RP-HPLC Analytical Method Development and Validation for Estimation of Pravastatin and Niacin in API and Pharmaceutical Formulation

Abstract

A reliable and efficient reverse phase high-performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous estimation of Pravastatin and Niacin in active pharmaceutical ingredients and combined pharmaceutical dosage forms. Method development involved systematic optimization of chromatographic conditions to achieve adequate resolution, symmetrical peak shapes, and acceptable retention times for both analytes. Separation was accomplished using a suitable C18 stationary phase with an optimized mobile phase composition, and detection was carried out at an appropriate ultraviolet wavelength.

The developed method was validated in accordance with ICH Q2 (R1) guidelines. Validation studies demonstrated excellent specificity, with no interference from formulation excipients. The method exhibited linearity over the selected concentration ranges for both Pravastatin and Niacin, with satisfactory correlation coefficients. Accuracy was confirmed through recovery studies, while precision was established by repeatability and intermediate precision assessments. Sensitivity of the method was evidenced by low limits of detection and quantification. Robustness studies indicated that minor deliberate variations in chromatographic parameters did not significantly affect method performance.

The proposed RP-HPLC method is simple, precise, accurate, and reproducible, making it suitable for routine quality control analysis, assay determination, and stability studies of Pravastatin and Niacin in bulk drugs and pharmaceutical formulations.