盐酸克林霉素棕榈酸酯含量测定方法的改进研究

目的： 建立HPLC-UV法测定盐酸克林霉素棕榈酸酯的含量。方法： 采用Waters Symmetry C₈（4.6mm×250 mm，5 μm）色谱柱，以0.005 mol·L-1醋酸铵溶液-乙腈（10：90）为流动相，流速1.0 mL·min^-1，检测波长为230 nm。结果： 克林霉素棕榈酸酯质量浓度在0.2~4.0 mg·mL^-1范围内线性关系良好（r=1.000）；平均回收率（n=3）为100.3%~102.0%，RSD为0.33%~0.72%；3批样品中盐酸克林霉素棕榈酸酯的含量分别为58.76%、58.56%、58.33%。结论： 该方法可作为盐酸克林霉素棕榈酸酯的定量分析方法。

Objective: To establish an HPLC-UV method for determination of clindamycin palmitate hydrochloride.Methods: Waters Symmetry C₈ column(4.6 mm×250 mm,5 μm)was used.The mobile phase consisted of 0.005 mol·L-1 ammonium acetate and acetonitrile(10:90)at the flow rate of 1.0 mL·min^-1,and the UV detection wavelength was 230 nm.Results: The good liner range of clindamycin palmitate was obtained between 0.2-4.0 mg·mL^-1(r=1.000).The average recovery rate(n=3)was 100.3%-102.0% with RSD of 0.33%-0.72%.The contents of clindamycin palmitate hydrochloride in three batches were 58.76%,58.56%,58.33%,respectively.Conclusion: This established HPLC-UV method can be used as a quantitative analysis method for clindamycin palmitate hydrochloride drug substance.

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