Isocratic HPLC determination of related substances of clindamycin palmitate hydrochloride and its drug products.

To develop isocratic HPLC method for the determination of related substances of clindamycin palmitate hydrochloride drug substance, dispersible tablets, granules and for suspension. The column was Agilent ZORBAX XDB-C8 (4.6 mm × 150 mm, 5 µm. The mobile phase consisted of 5 mmol L–1 ammonium acetate solution-acetonitrile (50: 50) (A) and acetonitrile (B) with gradient program. The flow rate was 1.0 mL min–1, and the detection wavelength was 230 nm. Good separation of clindamycin palmitate and ten intermediates could be achieved. The RSD of precision was 2.9%. The detection limit was 10 g mL–1. The method is simple, sensitive and reproducible, and can be used for quality control of clindamycin palmitate hydrochloride.