Abstract

A SIMPLE VALIDATED UV SPECTROPHOTOMETRIC METHOD FOR QUANTITATIVE ANALYSIS OF CETILISTAT IN PHARMACEUTICAL DOSAGE FORM

Prof. Dr. M. S. Kalshetti and R. N. Jalkote*

ABSTRACT

A simple, precise, accurate, economical and reliable UV Spectrophotometric method has been developed for the estimation of Cetilistat in tablet dosage form. The drug shows maximum absorption at 321 nm in n-hexane and ethanol (80:20) and obeys Beer’s law in the concentration range of 60-100 μg /mL with good correlation coefficient (R2=0.9992). The results of analysis were validated by recovery studies. The recovery was found to be 97-98 %. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 3.1781μg/ml and 9.8312μg/ml respectively. The relative standard deviation was found to be < 2.0 % in all cases. The Proposed Spectrophotometric method was validated as per the ICH Q2 (R1) guidelines. The proposed method can be used for the reliable quantification of Cetilistat in bulk form and routine analysis of pharmaceutical formulations.

Keywords: Cetilistat, UV Spectrophotometry, Absorbance maxima, Method validation.