Posted by admin on Jul 31, 2017 in |
Impurities will be present in all drug substances and drug products, i.e. nothing is 100% pure if one looks in enough depth. The current regulatory guidance on impurities accepts this, and for drug products with a dose of less than 2 g/day identification of impurities is set at 0.1% levels and above (ICH Q3B (R2), 2006). For some impurities, this is a simple undertaking as generally available analytical techniques can address the prevailing analytical challenges; whereas, for others this may be much more challenging requiring more sophisticated analytical approaches. The present review provides an insight into current development of analytical techniques to investigate and quantify impurities in drug substances and drug products providing discussion of progress particular within the field of chromatography to ensure separation of and quantification of those related impurities. Further, a section is devoted to the identification of classical impurities, but in addition, inorganic (metal residues) and solid state impurities are also discussed. Risk control strategies for pharmaceutical impurities aligned with several of the ICH guidelines,...
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Posted by admin on Jul 31, 2017 in |
Peptides are recognized for being highly selective efficacious and at the same time, relatively safe and well tolerated. Consequently, there is an increased interest in peptides, in pharmaceutical research and development (R&D) and approximately 140 peptide therapeutics are currently being evaluated in clinical trials. Ultrasonic is an area of intense scientific and technological research, science and technology of ultrasonics are widely used in the recent years for industrial and medical applications. Ultrasonic investigation in non- aqueous solutions of electrolytes and non- electrolytes with amino acids provide useful information in understanding the behaviour of liquid/solution system. In the present work, the ultrasonic velocity of a peptide with drug in formamide have been measured at various concentrations and at different temperatures. Using the measured value the thermodynamic parameters and acoustical parameters are calculated. These parameters have been utilized to study the interionic and intermolecular interactions existing in the system. The results arrived from ultrasonic methods have been corroborated with antimicrobial...
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Posted by admin on Jul 31, 2017 in |
In the present study, the hypolipidemic activity of Piper longum (Family: Piperaceae) fruit extract was studied in two experimental models of hyperlipidemia. In an acute model of hyperlipidemia, induced by injecting a single dose of triton WR-1339 (400 mg/kg, b.w.) intraperitonially in rats, administration of Piper longum extract at the dose of 500 mg/ kg, b.w. resulted in significant lipid lowering effect of total cholesterol (TC), phospholipids (PL), triglyceride (TG) and reactivation of post heparin lipolytic activity (PHLA). We observed significant decrease in TC, PL and TG levels by 32%, 19%, 39%, respectively, and increase in PHLA activity by 29% as compared to hyperlipidemic animals. In the chronic model, hyperlipidemia induced by cholesterol rich-high fat diet, we recorded significant decrease in TC, PL and TG levels by 27%, 15%, 34%, respectively, and increase in PHLA activity by 20 % as compared to hyperlipidemic animals. The treatment with fruit extract of Piper longum (500 mg/ kg b.w) simultaneously for 15 days also caused lowering of lipid levels in liver homogenate,...
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Posted by admin on Jul 31, 2017 in |
Eulophia nuda Lind. belongs to family Orichidaceae and is a rare and endangered orchid. Present research work was carried out on tuber extracts of Eulophia nuda for the evaluation of antimicrobial activities and hepatoprotective. Preliminary phytochemical screening revealed presence of phytochemical constituents like alkaloids, flavonoids, steroids, glycosides (cardiac), tannins, saponins, carbohydrates in three tuber extracts prepared by using solvents (chloroform, acetone and ethanol). Antibacterial activity was carried out with Disc Diffusion method against Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus. Acetone extract was more effective against Staphylococcus aureus with maximum zone of inhibition 18 mm compared to standard antibiotic Ampicillin with zone of inhibition 20 mm. Antifungal studies was carried out using well diffusion method against Candida albicans, Aspergillus niger and Aspergillus flavus. Chloroform extract was more effective against Aspergillus niger having zone of inhibition 17 mm compared with standard antifungal Fluconazole (20mm). Acetone extract shown the zone of inhibition of 16 mm against Aspergillus flavus compared to standard Fluconazole (22mm). Hepatoprotective activity was carried out as per OECD...
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Posted by admin on Jul 31, 2017 in |
A new stability indicating RP HPLC method has been developed and validated for simultaneous estimation of Metformin Hydrochloride and Canagliflozin in bulk and dosage forms. The method involves separation on Kromasil C18 column (250mm x 4.6mm x5µm particle size). The optimized mobile phase consists of 0.1% OPA (pH 2.8) and Acetonitrile (45:55v/v) with a flow rate of 1ml/min and UV detection at 254mn. Retention time was 2.112 min (Metformin Hydrochloride), 2.671 min (Canagliflozin). Linearity range was 25-150ug/ml (Metformin Hydrochloride), 2.5-15ug/ml (Canagliflozin). Accuracy was in the range of 98.22-101.54% for both drugs. Precision was 0.63% and 0.65% for Metformin Hydrochloride and Canagliflozin. LOD and LOQ are 0.17ug/ml and 2.20ug/ml for Metformin Hydrochloride, 0.01ug/ml and 0.50ug/ml for Canagliflozin. The method developed is more sensitive, accurate and precise than the methods reported earlier. Retention time and run time were also less and hence the method is economical. When applied for tablet assay, drug content was within 98.55-101.4% of labelled content. Forced degradation studies indicated the suitability of the method for stability...
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