Kumawat, Prashanth and Jagadish, PC and Muddukrishna, * and Bhat, Krishnamurthy (2014) Development and validation of stability indicating HPLC method for clotrimazole lozenges fomulation. International Journal of Pharmacy and Pharmaceutical Sciences, 6 (1). pp. 126-129. ISSN 0975-1491

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Abstract

Objective: A simple, sensitive, precise and accurate stability-indicating HPLC method has been developed and validated for determination of Clotrimazole (CLOT) in its lozenges dosage form. Methods: The mobile phase consists of 0.1% Tri-ethylamine in water (pH 3.00±0.05 adjusted by using Ortho-phosphoric acid) and Methanol in ratio of (25:75 v/v %) with isocratic programming, Gracemart C18 (250mm×4.6mm, 5μ) column used as stationary phase with a flow rate of 1.0 mL/minute. The detection wavelength was set at 215 nm. Results: The retention time of clotrimazole was found to be 5.5 ± 0.008 min. Clotrimazole was subjected to different stress testing conditions. The degradation products were well resolved from the drug under the tested conditions. The method was linear (r = 0.9998) at a concentration range of 0.5 to 60 μg/mL. Precision study showed that the percentage relative standard deviation was within acceptable limits, and the mean recovery was found to be 100.75% ± 1.51 for assay of Clotrimazole in lozenges dosage form. Conclusion: The results demonstrated that the method would have a great value when applied in quality control and stability studies for Clotrimazole.

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