Abstract

STABIILITY INDICATING METHOD DEVELOPMENT AND VALIDATION OF FENOFIBRIC ACID AND PITAVASTATIN BY USING RP – HPLC TECHNIQUE

D. Sirisha*, Dr. K. Atchuta Kumar

ABSTRACT

Analytical methods involve employing a particular technique along with specific step-by-step guidelines that are utilized in the qualitative, quantitative, or structural examination of a sample for one or multiple analytes. Method validation is a “process of creating documented proof” that offers a strong assurance that the product (equipment) will fulfill the needs of the intended analytical applications. Using RP-HPLC, a straightforward, precise, and accurate technique was created for measuring Fenofibric Acid and Pitavastatin. The peaks were distinctly resolved at 254nm in isocratic mode at retention times of 5.800 and 7.895 min for Fenofibric Acid and Pitavastatin, respectively, using a flow rate of 1.0 ml/min with a Welchrom 250mm x 4.6mm, 5µm column over 15min. Phosphate buffer: A 50:50 mixture of acetonitrile serves as the mobile phase. The % Assay results for Fenofibric Acid and Pitavastatin were 99.00% and 99.90%, respectively. The linear correlation coefficient was 1.000 for Fenofibric Acid and 0.9900 for Pitavastatin. The established method was verified according to ICH guidelines and is designed for regular quality control tasks in the development of pharmaceutical drugs.

Keywords: Fenofibric Acid, Pitavastatin, Method development and validation, ICH guidelines, & RP-HPLC.