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.
梁萌, 王玉丽, 杨阳, 高春生. 高效液相色谱法测定长循环自体红细胞载体中克林霉素磷酸酯和克林霉素的含量[J]. 中国药学杂志, 2020, 55(10): 838-842.
LIANG Meng, WANG Yu-li, YANG Yang, GAO Chun-sheng. Determination of Clindamycin Phosphate and Clindamycin in Long-Circulating Autologous Erythrocyte-Based Drug by HPLC. Chinese Pharmaceutical Journal, 2020, 55(10): 838-842.
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