'Routine quality control' presentation slideshows

Overall Course Overview:

406 views • 31 slides

Environmental Laboratory Central Analytical Facility - Stellenbosch University Victoria Street, Lombardi Building, Room

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A Discriminating UV-Spectrophotometric Method for In-Vitro Dissolution Study of Sertraline Hydrochloride in Tablet Dosag

The aim of this work was to develop and validate a dissolution test for Sertraline Hydrochloride in tablets using UV-Spectrophotometric method. The dissolution established conditions were: 900 ml of 0.05M Acetate buffer pH 4.5 as dissolution medium, using a paddle apparatus at a stirring rate of 75 rpm. The drug release was evaluated by UV-Spectrophotometric method at 274 nm. The method was successfully applied to marketed formulations containing 50 mg Sertraline Hydrochloride. More than 90% drug release was achieved in 45 min. in all products. The method was validated to meet requirements for a global regulatory filing. The validation included specificity, linearity, precision and accuracy. The dissolution test developed was adequate for its purpose and could be employed for routine quality control of Sertraline Hydrochloride tablets.

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Quantitation of alpha amyrin in Scoparia dulcis L. whole plant powder by high performance liquid chromatography

A rapid and sensitive HPLC method with UV detection (206 nm) for routine analysis of alpha amyrin from Scoparia dulcis plant extract was developed. Chromatography was performed with mobile phase containing a mixture of acetonitrile and water (59:41) with a flow rate of 1.5 mL min-1. The procedure was validated by linearity (correlation coefficient = 0.9997), accuracy, robustness and intermediate precision. Limit of quantitation and Limit of detection were found to be 1.2 µg and 0.4 µg respectively; this indicates the method is highly sensitive. Linearity was established by analyzing different concentration levels of alpha amyrin ranging from 0.008mg mL-1 to 0.032 mg mL- . For method precision the percent relative standard deviation was 2.96 and for intermediate precision it was 2.05 (n=6) value indicated a good precision of the analytical method.

83 views • 7 slides