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目的:建立中空纤维离心超滤的样品前处理技术结合HPLC法测定盐酸环丙沙星凝胶剂的含量。方法:采用中空纤维离心超滤技术对凝胶样品进行提取分离,基于中空纤维超滤膜特异性截留大分子原理,有效滤除了样品溶液中的高分子凝胶辅料卡波姆,超滤液直接进色谱分析。采用Promosil C_(18)柱(150×4.60 mm,5μm),流动相为甲醇-水(28∶72,含0.5%的三乙胺,用磷酸调节至pH4.0),检测波长为278 nm。结果:盐酸环丙沙星在2.51~25.1μg·mL-1范围内呈良好的线性关系(r=0.999 7),样品平均回收率为101.0%,RSD小于2%。结论:所建方法简便,快速,定量准确,色谱峰形良好,可用于盐酸环丙沙星凝胶剂的含量测定。
OBJECTIVE: To establish a sample pretreatment technique for hollow fiber ultrafiltration and determine the content of ciprofloxacin hydrochloride gel by HPLC. Methods: The hollow fiber ultrafiltration technique was used to extract and separate the gel samples. Based on the principle of hollow fiber ultrafiltration membrane specific interception of macromolecules, the polymer gel excipient carbomer and ultrafiltrate in the sample solution were effectively filtered out. Chromatographic analysis. The mobile phase was methanol-water (28:72, containing 0.5% triethylamine and adjusted to pH 4.0 with phosphoric acid) using a Promosil C 18 column (150 × 4.60 mm, 5 μm) at a detection wavelength of 278 nm. Results: Ciprofloxacin showed a good linear relationship (r = 0.999 7) in the range of 2.51 ~ 25.1μg · mL-1. The average recovery was 101.0% and the RSD was less than 2%. Conclusion: The proposed method is simple, rapid, accurate and accurate. It can be used for the determination of ciprofloxacin hydrochloride gel.