Paper Title
ANALYTICAL VALIDATION METHOD OF ANTIHYPERLIPIDEMIC DRUG USING RPHPLCAbstract
This study describes the analytical validation of a reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous quantification of two antihyperlipidemic drugs, Pravastatin Sodium and Fenofibrate. The method was developed and validated following the guidelines of the International Conference on Harmonization (ICH) for specificity, linearity, accuracy, precision, robustness, and system suitability. The RP-HPLC method utilized an appropriate stationary phase and optimized mobile phase composition for efficient separation and quantification of Pravastatin Sodium and Fenofibrate. Specificity was demonstrated by analyzing the drugs in the presence of potential impurities and excipients commonly found in pharmaceutical formulations. Linearity was evaluated over a range of concentrations, and accuracy and precision were assessed through recovery studies and repeatability tests, respectively. Robustness of the method was evaluated by varying chromatographic conditions such as flow rate, column temperature, and mobile phase composition. System suitability parameters were determined to ensure consistent performance of the chromatographic system. The validated RP-HPLC method exhibited satisfactory results in terms of specificity, linearity, accuracy, precision, robustness, and system suitability, indicating its suitability for routine analysis of Pravastatin Sodium and Fenofibrate in pharmaceutical formulations. This validated method can serve as a reliable tool for quality control purposes in the pharmaceutical industry, particularly in the development and manufacturing of antihyperlipidemic drug products.
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