World Journal of
Pharmaceutical and Life Sciences

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD OF DRUG CETILISTAT IN BULK AND PHARMACEUTICAL FORMULATION

Samie Sable and Kanchan Chauhan*

ABSTRACT

Cetilistat is a new drug utilized in a treatment of obesity. Since no High Performance Liquid Chromatographic method has been reported in literature, an attempt was made to develop and validate a simple, rapid accurate and precise stability indicating RP-HPLC method for estimation of cetilistat in bulk and pharmaceutical dosage forms as per ICH guidelines. The separation was carried out by using mobile phase consisting of acetonitrile and phosphate buffer of pH 4.0 in the ratio 60:40 using BDS Hypersil C-18 (250×4.6?m) at the flow rate of 1.0 ml/min. The retention time of cetilistat was found to be 2.73 min at wavelength 228 nm. The method was found to be linear over the concentration range of 20-100 ?g/ml with correlation coefficient 0.9986. Mean percent recovery of cetilistat sample solutions was found to be 100.26%. The limit of detection and limit of quantification for cetilistat was found to be 1.961?g/ml and 5.944 ?g/ml respectively. To check the stability of drug, forced degradation was carried out under different stress condition recommended by International Conference on Harmonization (ICH). In acidic condition mild degradation was seen whereas significant degradation took place under alkaline and thermal condition. No degradation was seen under oxidative condition. From the results it was found that the proposed RP-HPLC method was simple, rapid, precise, accurate, robust and stability indicating and hence can be successfully used for the routine analysis of cetilistat in pharmaceutical formulation.

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