Stability-Indicating Reversed-Phase Liquid Chromatographic Method for Simultaneous Determination of Simvastatin and Ezetimibe from Their Combination Drug Products

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Abstract:

A simple, precise, and rapid stability-indicating reversed-phase column liquid chromatographic (RP-LC) method has been developed and subsequently validated for simultaneous estimation of simvastatin (SIM) and ezetimibe (EZE) from their combination drug product. The proposed RP-LC method utilizes a LiChrospher 100 C18, 5 m, 250 4.0 mm id column at ambient temperature; optimum mobile phase consisting of acetonitrilewatermethanol (60 + 25 + 15, v/v/v) with apparent pH adjusted to 4.0 0.1; mobile phase flow rate of 1.5 mL/min; and ultraviolet detection at 238 nm. SIM, EZE, and their combination drug product were exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. There were no other coeluting, interfering peaks from excipients, impurities, or degradation products due to variable stress conditions, and the method is specific for the estimation of SIM and EZE in the presence of degradation products. The described method was linear over the range of 180 and 380 g/mL for SIM and EZE, respectively. The mean recoveries were 99.17 and 100.43 for SIM and EZE, respectively. The intermediate precision data were obtained under different experimental conditions, and the calculated value of the coefficient of variation was found to be less than the critical value. The proposed method can be useful in the quality control of bulk manufacturing and pharmaceutical dosage forms.

Document Type: Research Article

Affiliations: 1: Shri B.M. Shah College of Pharmacy, College Campus, Modasa-383 315, Gujarat, India. 2: Shri B.M. Shah College of Pharmaceutical Education and Research, College Campus, Modasa-383 315, Gujarat, India.

Publication date: September 1, 2007

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  • The Journal of AOAC INTERNATIONAL publishes refereed papers and reviews in the fields of chemical, biological and toxicological analytical chemistry for the purpose of showcasing the most precise, accurate and sensitive methods for analysis of foods, food additives, supplements and contaminants, cosmetics, drugs, toxins, hazardous substances, pesticides, feeds, fertilizers and the environment available at that point in time. The scope of the Journal includes unpublished original research describing new analytical methods, techniques and applications; improved approaches to sampling, both in the field and the laboratory; better methods of preparing samples for analysis; collaborative studies substantiating the performance of a given method; statistical techniques for evaluating data. The Journal will also publish other articles of general interest to its audience, e.g., technical communications; cautionary notes; comments on techniques, apparatus, and reagents.
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