Abstract
A simple, accurate, rapid and precise isocratic stability indicating reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of Clindamycin and Adapalene in tablets. The chromatographic separation was carried out on C18 BDS Hypersil (150 x 4.6mm, 5µ) with a mixture of mixed phosphate buffer: acetonitrile (55:45%v/v) as a mobile phase at a flow rate of 1.0mL/min. UV detection was performed at 230nm. The retention times were 2.84 and 3.999 min for Clindamycin and Adapalene respectively. Calibration plots were linear (r2=0.999) over the concentration range of 25-150µg/mL for Clindamycin and 2.5-15µg/mL for Adapalene. The method was validated for accuracy, precisio006E, specificity, linearity and sensitivity. The proposed method was successfully used for quantitative analysis of tablets. No interference from any component of pharmaceutical dosage form was observed. Validation studies revealed that method is specific, rapid, reliable, and reproducible. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of Clindamycin and Adapalene in bulk and tablet dosage form.
Highlights
The supernatant liquid layer, which contains the analytes of interest, was separated
The developed method was validated according to International Conference on Harmonization (ICH) guidelines
Acid degradation studies: To 1ml of stock solution of Adapalene and Clindamycin, 1ml of 2N Hydrochloric acid was added and refluxed for 30mins at 600c .The resultant solution was diluted to obtain 100μg/ml&10μg/ml solution and 10 μl solutions were injected into the system and the chromatograms were recorded to assess the stability of sample
Summary
Form and validate it, in accordance with International Conference on Harmonization (ICH) [11,12] guidelines. The supernatant liquid layer, which contains the analytes of interest, was separated
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