NOVEL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF PRAVASTATIN IN PURE AND PHARMACEUTICAL FORMULATION
Abstract
Introduction: A simple, rapid, precise, accurate, sensitive and stability indicating RP-HPLC method for the determination of Pravastatin in pure and tablet dosage form.
Materials & Methods: HPLC Method was developed using Zorbax ODS (250×4.6 mm ×5 μ) with the mobile phase of 0.1% formic acid pH adjusted to 3 and methanol in the ratio 50:50 v/v. Pravastatin peak was monitored at 238 nm, and the retention time was 4.44 minutes.
Results and Discussion: ICH guidelines were followed to validate the proposed method regarding specificity, precision, linearity, accuracy, system suitability, and robustness. The method was found to be linear in the range of 10–50 μg/mL, and also the regression equation was found to be y=124936 x+19884 R2=0.997. For intra- and inter-day precision, the %RSD for Pravastatin was 1.05 and 0.917%. Percentage mean recovery was found to be 98.36%. LOD and LOQ values were 0.231 and 0.701 μg/mL, respectively. Pravastatin stability was inspected under various forced degradation conditions, and it was found to be easily degraded in acidic and basic conditions.
Conclusion: The developed method was found to be having a suitable application for routine quality control analysis of Pravastain in pharmaceutical formulations.
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