Posted by admin on Jul 31, 2023 in |
Sudden cardiac death (SCD) is the most common cause of mortality among cardiovascular etiologies. Drug-induced Long-QT syndrome (diLQTS) is a prominent occurrence in Intensive Care Units (ICUs), often progressing to Torsades de Pointes (TdP), resulting in SCD. A prospective observational cross-sectional study was conducted to determine the prevalence of risk factors for diLQTS and to identify patients at risk for it in ICUs using the Tisdale score. Patients were recruited based on the selection criteria, and data on their demographics, laboratory and ECG assessments and administered medications were obtained from their case files. The prevalence of risk factors was calculated and the risk for diLQTS among the patients was assessed using the Tisdale score. Among 150 patients recruited, 51% and 49% were male and female, respectively, mostly aged >65 years (38%). QTc-prolongation was prevalent in 46% of patients. The prevalence of risk factors among the patients was: 35.33% aged ≥68 years, 40% females, 42% hypokalemic, 14% with acute MI, 28% with heart failure, 4% with sepsis, 24.66% prescribed with...
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Posted by admin on Jul 31, 2023 in |
A new simple, accurate, rapid, selective and robust high-pressure liquid chromatography (HPLC) method was developed and validated for simultaneous estimating itraconazole and Terbinafine in bulk and marketed formulation. Acetonitrile and double distilled water was used as a mobile phase for chromatographic separation and estimation on C18 Targetsil column with dimensions 250×4.6 mm in the ratio of 90:10 v/v at flow rate of 1.0 ml/min. The detection was carried out with U.V. Visible detector (Shimadzu SPD10A) at 225 nm. The retention time for itraconazole (6.1 min) and for Terbinafine (9.8min) was obtained. The linearity range for itraconazole and Terbinafine was 1-8μg/ml with a coefficient of linear regression 0.996 and 0.992, respectively. The method was validated in accordance with the requirements of the International Conference on Harmonization (ICHQ2 (R1) 2005) guidelines for accuracy, precision, LOD & LOQ, linearity and...
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Posted by admin on Jun 30, 2023 in |
Bazedoxifene acetate represents a promising new treatment for osteoporosis. LC-MS SIR (Selective ion recording) mode, the shortest runtime method, was developed and validated for the trace level quantification of two potential genotoxic impurities, i.e., Impurity-A (1 – Benzyloxy – 4 – nitrobenzene) and Impurity – B (4-benzyloxy-2-bromopropiophenone) in Bazedoxifene acetate drug substance. The concentration limits of both genotoxic impurities were calculated a limit of 75ppm based on the concept of TTC (threshold of toxicological concern) and MDD (maximum daily dosage, which is 20mg/day for Bazedoxifene acetate drug substance). The mobile phase used for the method was 10mM Ammonium acetate and acetonitrile in the ratio of (30:70) v/v with isocratic mode elution at flow rate 0.6mL/min, stationary phase used as X-Bridge C18 (50×4.6) mm, 3.5µm and run time was 5 minutes. The Impurities were quantified by using MS detector SIR mode (Selective ion recording) at m/z of 230.12 and 319.01 for Impurity-A and Impurity-B, respectively. The detection limit (DL) was 1.4 ppm for both Impurity-A and Impurity-B. The quantification limit (QL)...
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Posted by admin on Jun 30, 2023 in |
Tinospora sinensis (Lour.) Merr. belongs to the family Menispermaceae is, an important medicinal plant. Ayurveda, an Indian medicinal system, strongly advocates use of T. sinensis as a rejuvenator and several other therapeutic activities. The study’s objectives were to assess the effect of the extraction procedure and different solvent systems on antioxidant, total phenol content and total flavonoid content of T. sinensis. Two conventional extraction methods, cold maceration and Soxhlet extraction, were used to extract four parts of the plant and six different solvent systems viz., petroleum ether, ethyl acetate, chloroform, acetone, ethanol and methanol were used according to their polarity gradient. The total phenolic content was determined using the Folin-Ciocalteau method, and total flavonoid content was determined by aluminium chloride. The antioxidant activity was performed following two in-vitro technique assays, DPPH and ABTS radical scavenging assay. All the extracts of six solvents have potent antioxidant activity and methanol and ethanol extracts showed higher levels. The assimilatory root, stem, root and leaf of T. sinensis possess total phenol and flavonoid...
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Posted by admin on Jun 30, 2023 in |
In this paper, a Quality by Design-guided and Risk Assessment (RA)-based study was performed to determine the Critical Material Attributes and the Critical Process Parameters. Direct compression method was applied for the preparation of ODT containing Brivaracetam using 22 factorial designs with the quantity of drug, pharmabust 500 and crosspovidone as independent variables. Pharmabust 500 and crosspovidone were used as Superdisintegrants. Design Expert 11.0 described adequately impact of selected variables as dependent (pharmabust 500 and crosspovidone) at various levels for response under study (DT and Drug Release at 2 min). Further Optimization of formulation was done using Factorial design (2 factor 2 levels) and established control strategy and design space of the formulation. Design validation was done and final optimized batch P7 was chosen from the design space. The final formulation P7 was tested for Accelerated Stability Studies for 1 month and found stable. As per the results obtained from the experiments, it can be concluded that QbD is an effective and efficient approach for developing quality into ODT...
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