Jenish Shah
Central America
Research Article
Modification and Validation of HPLC Analytical Method for Estimation of Clotrimazole in Health Care Products
Author(s): Shahnaz Usman, Ali Muhammad Zulfiqar, Jenish Shah, Venkat Ramesh and Sawarkar SudhirShahnaz Usman, Ali Muhammad Zulfiqar, Jenish Shah, Venkat Ramesh and Sawarkar Sudhir
Objective: The aim of the study was to modify the USP analytical method and validate it for the estimation of clotrimazole in health care cream by using reverse phase HPLC. Methods: LC-20AD liquid chromatography equipped with SPD-20A UV-VIS detector was used for analysis. The separation was done on C18 column which was attached with loop 20 μL. Mobile phase was consisting of methanol: K2HPO4 (85:15) and flow rate was 1.5 mL/min. The method was validated as per the ICH guidelines. Results: The method is selective and reproducible, capable to separate all possible excipients and help to quantify accurately the amount of clotrimazole in health care product. The percentage coefficient variation (% CV) of the retention times and the peak areas were 0.504% and 1.453%, respectively. The linearity was evaluated by least square method i.e., r2=0.9996. The limits of detection (LOD) and limit.. View More»
