RP-HPLC Method Development and Validation for the Simultaneous Determination of Clindamycin and Miconazole in Pharmaceutical Dosage Forms

摘要

Objective: A simple, precise, reliable, rapid and reproducible reversed phase–high-performance liquid chromatographymethod was developed and validated for the simultaneous estimation of Clindamycin (CDM) and Miconazole (MCZ)present in tablet dosage forms. Method: Chromatographic separation achieved isocratically on Inertsil ODS C18 (250x4.6mm, 5 mm) column and buffer (pH 3.5) and acetonitrile (65:35 v/v) as mobile phase, at a flow rate of 1 ml/min. Detectionwas carried out at 220 nm. Parameters such as linearity, precision, accuracy, recovery, specificity and ruggedness arestudied as reported in the ICH guidelines. Results: The retention times for CDM and MCZ was found to be 2.2 and3.2 min, respectively. Linearity for CDM and MCZ was in the range of 5-30 μg/ml and 10-60 μg/ml, respectively. Themean recoveries obtained for CDM and MCZ were 99.73 ± 0.8 and 100.2 ± 0.58%, respectively, and Relative standarddeviation (RSD) was less than 2. The correlation coefficients for all components are close to 1. The RSDs for three replicatemeasurements in three concentrations of samples in tablets are always less than 2%. Conclusion: Developed method wasfound to be accurate, precise, selective and rapid for simultaneous estimation of CDM and MCZ in tablets.