ANALYTICAL METHODS FOR THE DETERMINATION OF STATIN DRUGS USED IN DYSLIPIDEMIA AND HYPERCHOLESTEROLEMIA
HTML Full TextANALYTICAL METHODS FOR THE DETERMINATION OF STATIN DRUGS USED IN DYSLIPIDEMIA AND HYPERCHOLESTEROLEMIA
N. Tumung *, H. Jajo, S. Bairagi and B. Shrestha
Department of Pharmaceutical Analysis, Himalayan Pharmacy Institute, Majhitar, East Sikkim, India.
ABSTRACT: Statins are the first line of defense in the treatment of dyslipidemia and hypercholesterolemia illness. HMG-CoA reductase inhibitors or statins are the most widely prescribed drugs for persons at risk of cardiovascular disease. Cardiovascular disease (CVD) is the leading cause of death and a major cause of morbidity around the world. Statins have the same mechanism of action, but their chemical structures, pharmacokinetic profiles, and lipid-modifying potency differ. Triglycerides, cholesterol, and low-density lipoprotein (LDL) levels in the blood are all known risk factors for vascular disease, but statin drugs help to increase high-density lipoprotein (HDL) levels in our bloodstream. Some of the drugs utilized include rosuvastatin, atorvastatin, simvastatin, and pravastatin. According to clinical data, rosuvastatin is the most effective drug for decreasing low-density lipoprotein cholesterol and triglycerides, followed by atorvastatin, simvastatin and pravastatin. A brief review of the analytical methods developed from 2001-2021 for the estimation of Antilipidemic drugs has been discussed in the present study. This study will help the researchers to develop better methods for this class of drugs.
Keywords: Statins, Hypercholesterolemia, Drugs, Analytical methods
INTRODUCTION: Around the world, cardiovascular disease (CVD) is the leading cause of death and a major cause of morbidity. A major goal of medical treatment is to lower high blood cholesterol, a risk factor for cardiovascular disease. Because statins lower blood cholesterol, they are the first-line treatment. All causes of mortality, coronary heart disease, and stroke events were reduced with statins as was for revascularization 1.
It took several years for the causal link between blood cholesterol levels and the risk of coronary heart disease to be widely accepted. In 1970, scientists in atherosclerosis research were firmly convinced that cholesterol-lowering would work. Interest in pharmacological approaches began as early as the 1950s and ultimately led to the discovery of statins 2.
Clinical investigations were beginning to show the role of cholesterol in atherosclerosis, necessitating the creation of new drugs. In 1976, Japanese researcher Akira Endo identified three compounds from the fungus Penicillium citrinum that were able to block the 3-hydroxy-3-methylglutaryl-CoA reductase (HMG-CoA) enzyme in a mouse liver enzyme system, preventing cholesterol synthesis 3.
Because of their efficacy and safety profile, statins are the treatment of choice for hypercholesterolemia. They're also becoming more essential in managing cardiovascular risk in persons with quite low plasma cholesterol levels. Statins have the same mechanism of action, although they differ in chemical structures, pharmacokinetic profiles, and lipid-lowering potency. The chemical structures of statins govern their water solubility, which controls their absorption, distribution, metabolism, and excretion. Lipophilic statins are taken up by active carrier-mediated processes in the liver due to first-pass metabolism and passive diffusion. In contrast, hydrophilic medicines are taken up by active carrier-mediated processes 4.
In recent clinical trials, statins have been proven to lessen the risk of stroke in persons with vascular disease. According to several epidemiological studies, hypercholesterolemia is the most prominent risk factor for coronary heart disease in industrialized countries. 3 – hydroxyl – 3 –methyl-glutaryl coenzyme A reductase inhibitors (statins) have been proven to decrease coronary events in the primary and secondary prevention of coronary heart disease. Triglyceride, cholesterol, low-density lipoprotein, and high-density lipoprotein abnormalities are all known risk factors for vascular disease. Cholesterol and low-density lipoprotein has a direct relationship with the incidence of coronary heart disease, while high-density lipoprotein has an inverse relationship 5. Furthermore, scientific research has revealed that rosuvastatin, followed by atorvastatin, simvastatin, and pravastatin, is the most effective medicine for decreasing LDL cholesterol. Statins (HMG-CoA reductase inhibitors) are among the most widely prescribed medications for persons at risk of cardiovascular events. However, statins are well tolerated by most patients 6.
Statins used in Dyslipidemia and Hyper-cholesterolemia: Astra-Zeneca produced rosuvastatin (C22H28FN3O6S), which was approved by the US Food and Drug Administration in 2003 7. It was created to help people with dyslipidemia and hypercholesterolemia. It's a novel HMG-CoA reductase inhibitor that stops cholesterol synthesis by inhibiting HMG-CoA reductase, the rate-limiting enzyme that converts HMG-CoA to mevalonate, a precursor of cholesterol 8-12. It's sold under the brand name Rosuvas. In tablet form, act as Rosuvas, Rosulip-F, and other similar products. Spectrophotometry 8-13, HPLC 14-19, and LC-MS 20-23 have all been used to create analytical procedures for determining Rosuvastatin Table 1.
FIG. 1: CHEMICAL STRUCTURE OF ROSUVASTATIN
Bruce Roth invented atorvastatin (C33H35FN2O5) in 1985. Lipitor was approved by the Food and Drug Administration (FDA) in 1996 24. In treating hyperlipidemias, it is used to lower LDL cholesterol, apolipoprotein B, and triglycerides while increasing HDL cholesterol 25. The enzyme (HMG-CoA) reductase catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis 26-29. It's sold under the brand name Atorva. In tablet form, act as X'tor, Vasolip, and other similar drugs. Spectrophotometry 30-34, HPLC 25, 26, 28, 29, 31, MS 24, 35, 36, and GC/MS 37 have all been used to create analytical procedures for determining Atorvastatin Table 2.
FIG. 2: CHEMICAL STRUCTURE OF ATORVASTATIN
Simvastatin (C25H38O5) was discovered and developed at Merck in 1980. It was the first member of the statin class and a derivative of an Aspergillus terreus fermentation product. This prodrug is metabolized to simvastatin hydroxy acid, a strong inhibitor of HMG CoA reductase, a crucial enzyme in cholesterol formation in the liver 38-40.
It's sold under the brand name Zocor. In tablet form, act as Simvas 10 and Starstat 10. Analytical approaches for determining Simvastatin have been included in HPLC 39-42, spectrophotometry 40, 43, and LC-MS 44 Table 3.
FIG. 3: CHEMICAL STRUCTURE OF SIMVASTATIN
Fluvastatin (C24H26FNO4) is a white crystalline powder that inhibits the enzyme hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase, a rate-limiting step in cholesterol biosynthesis that transforms HMG-CoA to mevalonate 45-48.
It lowers plasma lipoprotein and cholesterol levels, which helps to prevent cardiovascular disease 49. It is sold under the brand name Lescol XL. HPLC 45, 46, capillary electrophoresis 47, and spectro-photometry 48-51 have all been used to create analytical procedures for determining Fluvastatin Table 4.
FIG. 4: CHEMICAL STRUCTURE OF FLUVASTATIN
During the compactin medication research phase, Sankyo Co., Ltd. (now Daiichi Sankyo) found pravastatin (C23H36O7) as an active compactin metabolite in canine urine 53. Blocking the cholesterol-producing enzyme HMG-CoA reductase reduces cholesterol production in the liver 54-56. The drug pravastatin is used to treat hyperlipidemia and familial hypercholesterolemia. It's sold under the brand name Pravator. In pill form, it act as prastatin and pravator. HPLC 57, 58, 59, 61, capillary electrophoresis 54, LC-UV 55 and Spectrophotometry 56, 57, 60 were used to create analytical procedures for determining Pravastatin Table 5.
FIG. 5: CHEMICAL STRUCTURE OF PRAVASTATIN
TABLE 1: A REVIEW OF ANALYTICAL METHODS FOR ROSUVASTATIN
Method | Mobile phase/ reagent | Column | References |
Spectrophotometry | Methanol | 8 | |
Spectrophotometry | Methanol | 9 | |
Spectrophotometry (derivative) | Distilled water | 10 | |
Spectrophotometry | Acetonitrile, Phosphate buffer (pH 9.8) | 11 | |
Spectrophotometry | Methanol, Phosphate buffer | 12 | |
Spectrophotometry | Methanol | 13 | |
HPLC | Methanol: acetonitrile: water (40:40:20) | Thermo scientific C8 | 14 |
HPLC | Acetonitrile: Phosphatebuffer (50:50) | C 18 | 15 |
HPLC | Phosphate buffer (pH 2.5): Methanol:
Acetonitrile (45:33:22) |
Agilent Zorbax CYANO C 18 | 16 |
HPLC | toluene: chloroform: n-butanol: formic acid (6:2:1.5:0.5) | C 18 | 17 |
HPLC | Acetonitrile: water | ZORBAX EclipseC18 | 18 |
HPLC | ACN: methanol: water (20:25:55), pH 3adjusted with phosphoric acid | C 18 | 19 |
LC-MS | 0.1% formic acid: MeOH (20:80) | Phenomenex Kinetex C18 | 20 |
LC-MS | 0.1% formic acid: acetonitrile (30:70) | C18 | 21 |
LC-MS | ACN: formic acid (0.1%) (60:40) | Agilent Eclipse Plus ODS | 22 |
LC-MS | Methanol: water (with 0.1% formic acid) | Poroshell 120 EC-C18 | 23 |
TABLE 2: A REVIEW OF ANALYTICAL METHODS FOR ATORVASTATIN
Method | Mobile phase/ reagent | Column | References |
Spectrophotometry | Methanol | 30 | |
Spectrophotometry | Methanol | 31 | |
FTIR spectroscopy | Methanol | 32 | |
Spectrophotometry | Methanol | 33 | |
Spectrophotometry | Methanol | 34 | |
HPLC | Phosphate buffer (pH 4): Acetonitrile (90:10) | C 18 | 25 |
HPLC | Cetrimide: acetonitrile (35:65) | Nucleodur C18 | 26 |
HPLC | 0.025M phosphoric acid: acetonitrile (60:40) | C18 | 28 |
HPLC | Acetonitrile: methanol: 0.1% formic acid (50:10:40) | C 18 | 29 |
LC-Q-TOF-MS | ACN: aqueous 5mM ammonium formate solution | Zorbax Eclipse XDB-C18 | 35 |
LC-MS | Acetonitrile 0.025M: NaH2PO4: buffer pH 4.5 (55:45) | C 18 | 24 |
LC-MS | tertbutyl methyl ether: n-hexane (70:30) | Zorbax Eclipse XDB-C8 | 36 |
GC-MS | Hexane: methanol (1:50) | Capillary column HP5-MS | 37 |
TABLE 3: A REVIEW OF ANALYTICAL METHODS FOR SIMVASTATIN
Method | Mobile phase/reagent | Column | References |
HPLC | Acetonitrile: phosphate buffer
solution, pH 4 (25:75) |
C 18 | 39 |
HPLC | Ammonium acetate buffer (10 mM; pH 4.0): acetonitrile (40:60) | Symmetry C18 | 40 |
HPLC | Acetonitrile: potassium dihydrogen phosphate buffer (pH 4) (75:25) | C18 | 41 |
HPLC | Acetonitrile: water (pH 3.0 adjusted with ortho-phosphoric acid) (50:50) | Purospher Star C 18 | 42 |
Spectrophotometry | Methanol | 43 | |
Spectrophotometry | 0.25N NaOH | 44 | |
LC-MS | 0.04% formic acid in water) and mobile phase B (acetonitrile) | Acquity UPLC BEH C18 | 45 |
TABLE 4: A REVIEW OF ANALYTICAL METHODS FOR FLUVASTATIN
Method | Mobile phase/reagent | Column | References |
HPLC | Acetonitrile:0.1% orthophosphoric acid (50:50) | C18 | 46 |
HPLC | Acetonitrile: 0.02M potassium phosphate buffer (50: 50, v/v, pH 5) | Phenomenex LunaC18 | 47 |
Capillary Electrophoresis | Methanol | fused-silica capillary | 48 |
Spectrophotometry
(difference method) |
Methanol, 0.1N NaOH, 0.1N HCl | 49 | |
Spectrophotometry (derivative method) | Methanol | 50 | |
Spectrophotometry | Phosphate buffer 7.4 | 51 | |
Spectrophotometry | NaOH | 52 |
TABLE 5: A REVIEW OF ANALYTICAL METHODS FOR PRAVASTATIN
Method | Mobile phase/ reagent | Column | References |
HPLC | Acetonitrile (0.1%): diethylamine (50:50) | HYPERSIL C 18 | 57 |
HPLC | Methanol: phosphate buffer (70:30%) | C 18 | 58 |
HPLC | Water: acetonitrile: acetic acid(40:59:1) | Phenomex C 18 | 59 |
HPLC | ACN: MeOH(0.08M): Orthophosphoric acid (23:20:57) | Hypersil ODS | 61 |
Capillary Electrophoresis | borate buffer (pH 8.5): 10%acetonitrile | Fusedsilica capillary | 54 |
LC-UV | Methanol: water(80:20): 85% o-phosphoric acid | Purospher Star, C18 | 55 |
Spectrophotometry | Ethanol | 56 | |
Spectrophotometry (derivative method) | Methanol | 57 | |
Spectrophotometry | Methanol and acetonitrile | 60 |
CONCLUSION: The present study has discussed a brief review of the analytical methods developed from 2001-2021 for estimating Antilipidemic drugs. This current review paper included thorough information on statins which includes their mechanisms, essential features, and analytical methods reported by various authors. This study will help the researchers to develop better methods for these classes of drugs.
ACKNOWLEDGMENT: We would like to express our sincere gratitude to Director Dr. H. P. Chettri and Principal Dr. N. R. Bhuyan, Himalayan Pharmacy Institute, for their continuous support and encouragement.
Funding: None
CONFLICTS OF INTEREST: There were no conflicts of interest declared by the authors.
REFERENCES:
- Taylor F, Ward K, Moore TH, Burke M, Smith GD, Casas JP and Ebrahim S: Statins for the primary prevention of cardiovascular disease. Cochrane Database of Systematic Reviews 2011; (1).
- Steinberg D: Thematic review series: the pathogenesis of atherosclerosis. An interpretive history of the cholesterol controversy, part V: the discovery of the statins and the end of the controversy. Journal of Lipid Research 2006; 47(7): 1339-51.
- Grable‐Esposito P, Katzberg HD, Greenberg SA, Srinivasan J, Katz J and Amato AA: Immune‐mediated necrotizing myopathy associated with statins. Muscle & Nerve: Official Journal of the American Association of Electrodiagnostic Medicine 2010; 41(2): 185-90.
- Schachter M: Chemical, pharmacokinetic and pharmacodynamic properties of statins: an update. Fundamental & Clinical Pharmacology 2005; 19(1): 117-25.
- Paciaroni M, Hennerici M, Agnelli G and Bogousslavsky J: Statins and stroke prevention. Cerebrovascular Diseases 2007; 24(2-3): 170-82.
- Carter AA, Gomes T, Camacho X, Juurlink DN, Shah BR and Mamdani MM: Risk of incident diabetes among patients treated with statins: population-based study. BMJ 2013; 346.
- Angelo ML, Moreira FD, MoraisRuela AL, Santos AL, Salgado HR and de Araújo MB: Analytical methods for the determination of rosuvastatin in pharmaceutical formulations and biological fluids: A critical review. Critical Reviews in Analytical Chemistry 2018; 48(4): 317-29.
- Singh H, Gupta RD and Gautam G: Determination of Rosuvastatin Calcium in bulk and Pharmaceutical dosage forms by using UV-Spectrophotometric method. Asian Journal of Pharmacy and Pharmacology 2018; 4(1): 45-8.
- Gupta A, Mishra P and Shah K: Simple UV spectrophotometric determination of rosuvastatin calcium in pure form and in pharmaceutical formulations. E-journal of Chemistry 2009; 6(1): 89-92.
- Patel AI, Gosai SV, Vyas AJ, Patel NK and Patel AB: UV spectrophotometric estimation of propranolol hydrochloride and rosuvastatin calcium in synthetic mixture using first order derivative method. Asian Journal of Pharmaceutical Analysis 2020; 10(4).
- Ramadan AA, Mandil HA and Alshelhawi NO: Spectrophotometric determination of rosuvastatin calcium in pure form and pharmaceutical formulations by the oxidation using iodine and formation triiodide complex in acetonitrile. Int J Pharm Pharm Sci 2014; 6(5): 579-85.
- Jose E, Nair AC and Kuttichan M: Development and Validation of a Solvent Extraction UV Spectrophotometric Method for the Estimation of Rosuvastatin Calcium and Telmisartan in Combined Dosage Form. Research Journal of Pharmacy and Technology 2022; 15(5): 2065-9.
- Kumar PR, Padmavathi Y, Niveditha P and Babu NR: Development and validation of difference spectrophotometric method for the quantitative estimation of mesalamine in bulk drug and dosage forms. Asian Journal of Pharmaceutical Analysis 2017; 7(4).
- Jana K and Mahanti B: Development and Validation of a new improved RP-HPLC Method for estimation of Rosuvastatin calcium in Pharmaceutical dosage form. Research Journal of Pharmacy and Technology 2020; 13(6): 2886-92.
- Moid M, Afzal S, Rahim N, Ali T, Iffat W, Bashir L and Naz S: High performance liquid chromatographic method validation for determination of rosuvastatin calcium in tablet dosage forms. Pak J Pharm Sci 2018; 31(4): 1577-82.
- Celina N and Anushka B: Development and Validation of A Novel Cleaning Validation and Assay Method For Simultaneous Estimation of Rosuvastatin And Fenofibrate By RP-HPLC.
- Kalyankar GG, Ghariya VV, Bodiwala KB, Lodha SR and Joshi SV: Development and validation of HPTLC method for simultaneous estimation of Fenofibrate and Rosuvastatin in tablet dosage form. Journal of Pharmacy and Applied Sciences 2016; 3(1): 1.
- Hamdy MM, Korany MA, Ebied SA and Haggag RS: Stability-indicating RP-HPLC assay of three novel oral anticoagulants binary mixtures with rosuvastatin calcium: Application to pharmaceutical preparations and human plasma. J of Chromatography B 2022; 1193: 123160.
- Kumar P, Ankalgi AD, Kaushal P and Ashawat MS: Method development and validation for multicomponent analysis of rosuvastatin calcium and losartan potassium in bulk drug by RP-HPLC. Journal of Drug Delivery and Therapeutics 2020; 10(5): 76-84.
- Moon SJ, Lee SE, Kwak YG and Kim MG: Validation of LC-MS/MS method for determination of rosuvastatin concentration in human blood collected by volumetric absorptive microsampling (VAMS). Translational and Clinical Pharmacology 2021; 29(3): 125.
- Dayyih WA, Al-Shdefat R, Zakarya Z, Hamad M and Felicia G: Determination of Rosuvastatin and Dabigatran Simultaneously in Human Plasma for Application to Pharmacokinetic Parameters in Healthy Jordanian Subjects by LC-MS/MS-Method. Journal of Pharmaceutical Sciences and Research 2019; 11(8): 2934-41.
- Elgawish MS, Soltan MK and Sebaiy MM: An LC–MS/MS spectrometry method for the simultaneous determination of Rosuvastatin and Irbesartan in rat plasma: Insight into pharmacokinetic and drug-drug interaction studies. Journal of Pharmaceutical and Biomedical Analysis 2019; 174: 226-34.
- Zeng X, Su W, Liu H, Zheng Y, Chen T, Zhang W, Yan Z, Bai Y and Yao H: Simultaneous determination of rosuvastatin, naringin and naringenin in rat plasma by RRLC–MS/MS and its application to a pharmacokinetic drug interaction study. Journal of Chromatographic Science 2018; 56(7): 611-8.
- Roth BD: 1 the Discovery and Development of Atorvastatin, A Potent Novel Hypolipidemic Agent. Progress in Medicinal Chemistry 2002; 40: 1-22.
- Chaudhari SM, Prajapati KM, Luhar SV, Narkhede SB.RP-HPLC Method Development and validation for simultaneous stimation of atorvastatin, aspirin, ramipril and metoprolol succinateintablet dosage form. Pharma Science Monitor 2018; 9(2).
- Trefi S: Simultaneous assessment of atorvastatin-ezetimibe combination in tablets by an ion-pair RP-HPLC. Res. J. Pharm. Technol 2020; 13(9): 1-5.
- Mazurek S and Szostak R: Quantification of atorvastatin calcium in tablets by FT-Raman spectroscopy. J of Pharma and Biomedical Analysis 2009; 49(1): 168-72.
- Islam SA, Dewan I, Khatun R, Haider SS and Reza MS: Development and validation of a simple RP-HPLC method for the estimation of atorvastatin in self-emulsifying drug delivery system (SEDDS).
- Gaikwad VM: Development and validation of RP-HPLC method for simultaneous estimation of Atorvastatin and Irbesartan for combined dosage form. IJNRD-International Journal of Novel Research and Development (IJNRD). 2020; 5(11): 347-91.
- Qassim BB and Zydan AA: Sensitive simultaneous estimation of Atorvastatin. Ca in pure and dosage forms via developed CFIA using 1, 2 Naphthoquinone-4-sulfonate as a suitable organic agent. Indian Journal of Forensic Medicine & Toxicology 2020; 14(2): 2161.
- Chaudhari DP, Rane SS and Nemade MS: Development and validation of absorption ratio method for simultaneous estimation of atorvastatin and clopidogrel in formulation and bulk.
- Mounika PE, Padmavathi Y, Anjali AK and Reddy NP: Quantitative estimation of Atorvastatin calcium in bulk and tablet dosage forms using FTIR spectroscopy. International Journal of Pharma and Bio Sciences 2018; 9(2): 221-32.
- Singh S, Dubey N, Jain DK. Simultaneous estimation of atorvastatin, clopidogrel and aspirin in capsule dosage forms using UV-spectroscopy. Asian Journal of Research in Chemistry 2010; 3(4): 885-7.
- Lala RR and Shinde AS: Estimation of Atorvastatin Calcium and Vinpocetine in a Pharmaceutical Dosage form using Validated Simultaneous UV Spectroscopic and HPLC Methods. Quality Assurance 2021; 12(1): 26-30.
- Martín J, Buchberger W, Alonso E, Himmelsbach M and Aparicio I: Comparison of different extraction methods for the determination of statin drugs in wastewater and river water by HPLC/Q-TOF-MS. Talanta 2011; 85(1): 607-15.
- Bichala PK, Atmakuri LR and Kotra V: Development and validation of an LC-MS/MS method for determination of atorvastatin in human plasma. Asian Journal of Medicine and Health Sciences 2021; 4: 255.
- Wang M, Wang Y, Zhao M, Wang F, Zhao C. Metabolic profiling analysis of fatty acids from hyperlipidemic rats treated with Gynostemm apentaphyllum and atorvastatin based on GC/MS. Analytical Methods 2014; 6(21): 8660-7.
- Dixit RP, Barhate CR, Padhye SG, Viswanathan CL and Nagarsenker MS: Stability indicating RP-HPLC method for simultaneous determination of simvastatin and ezetimibe from tablet dosage form. Indian Journal of Pharmaceutical Sciences 2010; 72(2): 204.
- Sailesh WJ, Shivraj SS and Liyakat SI: Development and Validation of Stability Indicating RP-HPLC Method for the Estimation of Simvastatin in Bulk and Tablet Dosage form. Research Journal of Pharmacy and Technology 2018; 11(4): 1553-8.
- Alhazmi HA, Alnami AM, Arishi MA, Alameer RK, Al Bratty M, Rehman ZU, Javed SA and Arbab IA: A fast and validated reversed-phase HPLC method for simultaneous determination of simvastatin, atorvastatin, telmisartan and irbesartan in bulk drugs and tablet formulations. Scientia Pharmaceutica 2018; 86(1): 1.
- Pandey NK, Singh SK, Ghosh D, Khursheed R, Kumar R, Kapoor B, Kumar B and Awasthi A: Method development and validation for simultaneous estimation of glimepiride and simvastatin by using reversed phase high-performance liquid chromatography. Research Journal of Pharmacy and Technology 2020; 13(4): 1655-9.
- Naveed S, Usmanghani K, Sana A, Ali H, Zafar F, Qamar F, Sarwer G, Abbas S, Alam MT and Shinwari MI: Estimation of simvastatin and cetirizine by RP-LC method: Application to freeze and thaw (FT) stability studies. Pak J Pharm Sci 2018; 31(1): 137-41.
- Bandgar SA and Jadhav NR: Validated UV Spectrophotometric method for estimation of Simvastatin in Bulk and Pharmaceutical Formulation. Research Journal of Pharmacy and Technology 2019; 12(12): 5745-8.
- Popat M, Jyoti W, Pradnesh M and Sachin Y: Development and validation of Q-Absorbance ratio spectrophotometric method simultaneous estimation of simvastatin and labetalol HCl in combined dosage form.
- El-Zailik A, Cheung LK, Wang Y, Sherman V and Chow DS: Simultaneous LC–MS/MS analysis of simvastatin, atorvastatin, rosuvastatin and their active metabolites for plasma samples of obese patients underwent gastric bypass surgery. Journal of Pharmaceutical and Biomedical Analysis 2019; 164: 258-67.
- Sandhala D and Lankalapalli S: New Method for the in vivo Estimation of Fluvastatin and its Application for Pharmacokinetic Studies in Rabbit. Indian Journal of Pharmaceutical Education and Research 2020; 54(4): 1153-8.
- Akabari A, Saralai M, Sutariya V and Suhagia B: “Development and validation of stability indicating RP-HPLC method for estimation of Fluvastatin sodium in bulk and capsule dosage form. Journal of Analytical Chemistry 2017; 12(2): 87-105.
- Antakli S, Nejem L and Kullah A: Determination of pravastatin sodium by analytical Spectrophotometry. Research Journal of Pharmacy and Technology 2021; 14(2): 741-6.
- Tuljapure DS, Gowekar NM, Yadav SS and Mogale AS: Development and validation of difference spectrophotometric method for estimation of fluvastatin sodium and bulk dosage form. Am J Pharm Tech Res 2012; 2(4): 388-94.
- Stolarczyk M, Maślanka A, Apola A, Rybak W and Krzek J: Derivative spectrophotometric method for simultaneous determination of zofenopril and fluvastatin in mixtures and pharmaceutical dosage forms. Spectrochimica Acta Part A: Molecular and Biomol Spectroscopy 2015; 148: 66-71.
- Singh S, Sharma N, Kanojia N, Kaur G and Arora S: Development and validation of UV-spectrophotometer method for analysis of Fluvastatin sodium in polyethylene glycol 6000 and polyvinyl pyrollidone K30 solid dispersions. Plant Archives 2020; 20(1): 3365-71.
- Saminathan J, Sankar AS, Anandakumar K and Vetrichelvan T: Simple UV spectrophotometric method for the determination of fluvastatin sodium in bulk and pharmaceutical formulations. E-Journal of Chemistry 2009; 6(4): 1233-9.
- Hara Y and Nagaoka S: Pravastatin (Pravachol, Mevalotin). In Drug Discovery in Japan Springer Singapore 2019; 35-49.
- Kırcalı K, Tunçel M, Aboul-Enein HY. Determination of pravastatin in tablets by capillary electrophoresis. Il Farmaco 2004; 59(3): 241-4.
- Sultana N, Arayne MS and Ali SN: An Ultra-sensitive and selective LC-UV method for the simultaneous determination of pravastatin, diltiazem, naproxen sodium and meloxicam in API, pharmaceutical formulations and human serum. American J of Appl Chem 2013; 1(1): 1-8.
- Shi JH, Wang Q, Pan DQ, Liu TT and Jiang M: Characterization of interactions of simvastatin, pravastatin, fluvastatin and pitavastatin with bovine serum albumin: multiple spectroscopic and molecular docking. J of Biomol Structure and Dynamics 2017; 35(7): 1529-46.
- HeFnawy MM, MoHaMed MS, Abounassif MA, Alanazi AM and Mostafa GA: High-performance liquid chromatography and derivative spectrophotometry for simultaneous determination of pravastatin and fenofibrate in the dosage form. Acta Pharmaceutica 2014; 64(4): 433-46.
- Ahmad A, Raish M, Alkharfy KM, Mohsin K and Shakeel F: Box-Behnken supported development and validation of robust RP-HPLC method: an application in estimation of pravastatin in bulk and pharmaceutical dosage form. Journal of the Chilean Chemical Society 2016; 61(2): 2963-7.
- Athota RV, Jagarlapudi SK and Singampalli MR: Stability indicating HPLC method for the simultaneous quantification of aspirin and pravastatin in bulk and tablets: method development and validation. J Appl Pharm Sci 2017; 70(3).
- Antakli S, Nejem L, Kullah A. Determination of pravastatin sodium by analytical Spectrophotometry. Research J of Pharmacy and Tech 2021; 14(2): 741-6.
- Antakli S, Nejem L and Kullah A: Determination of pravastatin sodium by analytical Spectrophotometry. Research Journal of Pharmacy and Technology 2021; 14(2): 741-6.
How to cite this article:
Tumung N, Jajo H, Bairagi S and Shrestha B: Analytical methods for the determination of statin drugs used in dyslipidemia and hypercholesterolemia. Int J Pharm Sci & Res 2023; 14(3): 1435-41. doi: 10.13040/IJPSR.0975-8232.14(3).1435-41.
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English
IJPSR
N. Tumung *, H. Jajo, S. Bairagi and B. Shrestha
Department of Pharmaceutical Analysis, Himalayan Pharmacy Institute, Majhitar, East Sikkim, India.
nilotpalm.pharmofficial@gmail.com
23 July 2022
29 August 2022
09 September 2022
10.13040/IJPSR.0975-8232.14(3).1435-41
01 March 2023