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Method Development and Validation for Assay of Minocycline Hydrochloride in Dosage Forms by RP-HPLC

Alka Agarwal, I. J. Singhvi, S. K. Gupta, K. C. Gupta and M. Thakkar

A simple, fast, precise and accurate high performance liquid chromatographic method has been developed for the quantitative estimation of minocycline hydrochloride from powder for oral suspension formulation. The method was developed using acetonitrile : Phosphate buffer in the proportion of 25 : 75 v/v at flow rate of 0.5 mL/min as mobile phase. The separation was carried out on Inertsil ODS 3V C18 (250 mm x 4.6 mm, 5 µm) column and the eluents were detected at 280 nm. The linearity was observed in the concentration range of 100 to 900 µg/mL of minocycline hydrochloride. The LOD and LOQ of the method were 0.816 and 2.474 µg/mL, respectively. The system suitability parameters and other validation studies were performed to ensure accurate and precise method for estimation of minocycline hydrochloride.