Abstract

DEVELOPMENT AND VALIDATION OF UV VISIBLE SPECTROPHOTOMETER METHOD FOR ESTIMATION OF BEMPEDOIC ACID AND EZETIMIBE IN BULK DRUGS AND DOSAGE FORM

Nilesh V. Pawar* and Sanjay Bhawar

Abstract

Aim: The objective of present investigation is to develop and validate UV visible spectrophotometer method for estimation of Bempedoic acid and Ezetimibe in marketed formulation. Materials and Method: Dissolution media was used for the development of UV visible spectrophotometer method. Both drugs Bempedoic acid and Ezetimibe was detected using 226nm wavelength. According to ICH requirements, the developed method was validated in terms of selectivity, linear range, precision, robustness, ruggedness, and reproducibility. The developed method was successfully used to estimate Bempedoic acid and ezetimibe in marked formulation. Results: Bempedoic acid and Ezetimibe has absorption wavelength of 226nm. Beer’s law was followed at concentration ranging from 39.8995-299.2462 ppm for Bempedoic acid 2.2968 -17.226 ppm for Ezetimibe. The precision and repeatability scores were all within acceptable limits. Bempedoic acid and Ezetimibe recovery in marked formulation was found to be between 98-100%. The precision and repeatability values were within a 2% tolerance range. Conclusion: The method was found to be easy environmentally friendly, repeatable and cost effective and it can be used for Bempedoic acid and Ezetimibe analysis on regular basis.

Keywords: Bempedoic acid, Ezetimibe, Dissolution media, UV visible spectrophotometer.