RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF CLINDAMYCIN PHOSPHATE AND CLOTRIMAZOLE IN PHARMACEUTICAL DOSAGE FORMS
Keywords:
Clindamycin and Clotrimazole, RP-HPLC, ValidationAbstract
Objective: The aim of this work was to develop and validate a simple Reverse Phase-High Performance Liquid Chromatography method for the simultaneous estimation of Clindamycin and Clotrimazole in pharmaceutical dosage forms.
Methods: The mobile phase consists of phosphate buffer and Acetonitrile in the ratio of (48:52) with gradient programming, Hypersil BDS (250×4.6 mm,5µ) column used as stationary phase with a flow rate of 1 ml/min, injection volume 10 µl and the run time was 10 min. Detection wavelength was at 220 nm by using Photo Diode Array detector.
Results: The retention times of Clindamycin and Clotrimazole were found to be 2.2 min and 5.7 min respectively. The method was validated according to ICH guidelines. Validation parameters like accuracy, precision, linearity, range, limit of detection, limit of quantification and robustness all were within the limits. The linearity responses of Clindamycin and Clotrimazole were found to be in the concentration ranges of 25-150 µg/ml and 50-300 µg/ml. The percentage recovery for both drugs was found in the range of 99-100%. The LOD & LOQ values for were found to be 1.29µg/ml and 3.93µg/ml and Clotrimazole were found to be 1.31µg/ml and 3.96 µg/ml, respectively.
Conclusion: The results obtained are accurate and within the limits. Hence this method can be applicable for the estimation of Clindamycin and Clotrimazole in pharmaceutical dosage forms.
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