Abstract
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 limits of quantitation (LOQ) for clotrimazole were 0.25 μg/mL and 0.5 μg/mL respectively. The results of Instrumental precision were 103.5% with %CV of 0.612% and the intermediate precision was 0.35 to 1.43%. The recoveries at three concentrations levels over a range of 80 - 120% were found within the range of 101.2 to 103.8% as per ICH guidelines. The results of robustness show no major changes occurring over changes in flow rate from 1.4 mL/min. to 1.6 mL/min. The method was also applied for the analysis of clotrimazole in formulated health care cream and marketed pharmaceutical creams that contain clotrimazole. Conclusion: It was concluded that the method is so simple, easy and applicable. It could be easily used for the analysis of compound in its dosage form. The robustness and ruggedness of the method are significantly broader, reproducible and could be adjusted according the needs.
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