ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF CETILISTAT BY HPTLC METHOD

Kanchan Chauhan* and Samie Sable

ABSTRACT

Drug cetilistat is used in the treatment of obesity. There is no high performance thin layer chromatographic method has been reported in literature till date. Thus an attempt was made to develop and validate a simple, rapid accurate and precise high performance thin layer chromatographic method for estimation of cetilistat in pharmaceutical dosage forms as per ICH guidelines. Cetilistat was chromatographed on silica gel 60F254 TLC plate using n-hexane and methanol as mobile phase in the ratio of 8:2 v/v. Cetilistat was quantified by densitometric analysis at 228 nm. The method was found to give compact spots for the drug with Rf value 0.62± 0.01. The method was found to be linear over the concentration range of 200-1000 ng/spot with correlation coefficient 0.9985. The limit of detection and limit of quantification for Cetilistat was found to be 0.9094 ng/spot and 2.7558 ng/spot respectively. This method was validated with reference to linearity, accuracy, precision, specificity and robustness according to ICH guidelines.

Keywords: Cetilistat, HPTLC, densitometric analysis, Method validation.