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Method Development and Validation of Simultaneous Determination of Assay of Quinapril and Tolcapone
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A simple and selective HPLC method is developed for the simultaneous determination of quinapril and tolcopone. The chromatographic separation was achieved on a inertsil column, C18(150 X 4.6 ID) 5μm with mobile phase consisting of a mixture of 40 volumes of mixed phosphate buffer and 60 volumes of acetonitrile were prepared with a detection of wavelength of 239nm. The method was validated for analytical parameters such as specificity, accuracy, precision, robustness and ruggedness as per ICH guidelines. The correlation coefficient for linear curve obtained between concentration vs. Area for standard preparations of Quinapril and Tolcapone is 0.995 and 0.999. The percentage mean recovery of Quinapril and Tolcapone is 101.02% and 99.55% respectively. The proposed method was found to be simple, accurate, precise, and robust and stability indicating HPLC method. Hence this method can be used for routine analysis.
Keywords
RP-HPLC, Quinapril, Tolcapone, Method development, Validation.
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