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

梁萌, 王玉丽, 杨阳, 高春生

中国药学杂志 ›› 2020, Vol. 55 ›› Issue (10) : 838-842.

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中国药学杂志 ›› 2020, Vol. 55 ›› Issue (10) : 838-842. DOI: 10.11669/cpj.2020.10.016
论著

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

  • 梁萌, 王玉丽, 杨阳*, 高春生*
作者信息 +

Determination of Clindamycin Phosphate and Clindamycin in Long-Circulating Autologous Erythrocyte-Based Drug by HPLC

  • LIANG Meng, WANG Yu-li, YANG Yang*, GAO Chun-sheng*
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文章历史 +

摘要

目的 建立自体红细胞载体中包载的克林霉素磷酸酯和转化产生的克林霉素含量测定方法。方法 采用高效液相色谱法,色谱柱为Shimadzu Shim-pack VP-ODS色谱柱(4.6 mm×250 mm,5 μm),Waters Symmetry C18预柱(3.9 mm×22 mm,5 μm),内标为尼泊金甲酯,流动相为0.062 5 mol·L-1KH2PO4-乙腈(65∶35,V/V),流速为1.0 mL·min-1,柱温为25 ℃,检测波长为210 nm。结果 克林霉素磷酸酯在0.253~506 μg·mL-1内质量浓度与峰面积比值呈良好的线性关系,克林霉素在0.251~502 μg·mL-1内质量浓度与峰面积比值呈良好的线性关系,方法回收率大于98%,供试溶液在4 ℃和室温下放置24 h均稳定,精密度符合要求。结论 该方法快速、简便、准确、重复性好,可用于自体红细胞载体中克林霉素磷酸酯和转化产生的克林霉素含量的测定。

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.

关键词

载体药物 / 红细胞 / 克林霉素磷酸酯 / 克林霉素 / 高效液相色谱法

Key words

carrier drug / erythrocyte / clindamycin phosphate / clindamycin / high performance liquid chromatography

引用本文

导出引用
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 https://doi.org/10.11669/cpj.2020.10.016
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[J]. Chinese Pharmaceutical Journal, 2020, 55(10): 838-842 https://doi.org/10.11669/cpj.2020.10.016
中图分类号: R917   

参考文献

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基金

国家“重大新药创制”科技重大专项项目资助(2018ZX09711003-008)
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