UV Spectrophotometric Method Development and Validation for Determination of Cetilistat in API and in Pharmaceutical Dosage Form

Author(s)

Kshirsagar, S.A., Mane, S.B., Hanchate, Y.S., Katte, A.S.

Author's Affiliation

Abstract

Simple, rapid, sensitive, precise and specific UV Spectrophotometric for the determination of cetilistat in API and pharmaceutical dosage form were developed and validated. In this method solutions of cetilistat were prepared in n-hexane. Cetilistat standard solution was scanned in the UV range (400-200nm) in a 1cm quartz cell in a double beam UV spectrophotometer. The standard solution of cetilistat showed maximum absorption at wavelength 320.0 nm. The method obeys Beer’s law in the concentration range from 20-100µg/ml. The correlation coefficient was found to be 0.9996 and regression of the curve was found Y=0.0096x+0.0012 with excellent recovery 96-99%. Limit of detection and limit of quantification were found to be 2.7283µg/ml and 8.2677µg/ml respectively. The ruggedness and robustness were performed. The method was validated for several parameters like accuracy, precision as per ICH guidelines. Statistical analysis proved that the methods are repeatable and specific for determination of the said drug. These methods can be adopted in the routine assay analysis of cetilistat in API and pharmaceutical dosage form.

Keywords

Cetilistat, UV Spectrophotometry, Absorbance maxima, Method validation

Cite This Article

Kshirsagar, S. A., Mane, S. B., Hanchate, Y. S., & Katte, A. S. (2018). UV Spectrophotometric Method Development and Validation for Determination of Cetilistat in API and in Pharmaceutical Dosage Form, International Journal for Pharmaceutical Research Scholars , 7(1), 1-8.