Determination of Clindamycin Phosphate and Clindamycin in Long-Circulating Autologous Erythrocyte-Based Drug by HPLC / 中国药学杂志

ABSTRACT

OBJECTIVE: To establish a high performance liquid chromatography (HPLC) method to determine the contents of clindamycin phosphate and clindamycin in long-circulating autologous erythrocyte-based drug. METHODS: Clindamycin phosphate and clindamycin were determined by HPLC with Shimadzu Shim-pack VP-ODS chromatographic column (4.6 mm×250 mm, 5 μm) and Waters Symmetry C18 precolumn(3.9 mm×22 mm, 5 μm). The internal standard was nipagin ester. The mobile phase was composed of 0.062 5 mol•L-1 KH2PO4 and acetonitrile at 65∶35 (V/V) at a flow rate of 1.0 mL•min-1. The column temperature was maintained at 25 ℃ and the detection wavelength was set at 210 nm. RESULTS: The calibration curve of clindamycin phosphate showed good linearity in the range of 0.253-506 μg•mL-1, and the calibration curve of clindamycin showed good linearity in the range of 0.251-502 μg•mL-1. The average recovery was more than 98%. The test solution was stable at 4 ℃ and room temperature for 24 h, and the precision met requirements. CONCLUSION: The method is simple, specific, accurate and stable, which is suitable for the determination of clindamycin phosphate and clindamycin in long-circulating autologous erythrocyte-based drug.