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目的:采用固相萃取-高效液相色谱法分析复方甲硝唑阴道栓中甲硝唑和盐酸四环素的含量。方法:采用C18固相萃取小柱分离除去复方甲硝唑阴道栓中的基质,高效液相色谱法测定甲硝唑和盐酸四环素的含量。色谱柱为Luna C8(5μm,4.6mm×250mm);流动相为0.1mol.L-1草酸铵溶液-二甲基甲酰胺-0.2mol.L-1磷酸氢二铵溶液(65:30:5),检测波长为270nm,流速为1.0mL.min-1。结果:甲硝唑进样量在0.228～2.28μg,盐酸四环素进样量在0.0121～0.121μg范围内,线性关系良好;平均回收率(n=9)甲硝唑为98.8%,盐酸四环素为98.3%。结论:本方法灵敏快速,结果准确,重现性好,可用于该制剂的质量控制。
OBJECTIVE: To determine the content of metronidazole and tetracycline hydrochloride in compound metronidazole vaginal suppository by solid-phase extraction and high performance liquid chromatography. Methods: The matrix of compound metronidazole vaginal suppository was separated by C18 solid phase extraction cartridge, and the contents of metronidazole and tetracycline hydrochloride were determined by high performance liquid chromatography. The column was Luna C8 (5 μm, 4.6 mm × 250 mm); the mobile phase was 0.1 mol·L-1 ammonium oxalate solution-dimethylformamide-0.2 mol·L-1 diammonium hydrogen phosphate solution ), Detection wavelength of 270nm, flow rate of 1.0mL.min-1. Results: The metronidazole injection volume was 0.228 ~ 2.28μg, tetracycline hydrochloride injection volume was in the range of 0.0121 ~ 0.121μg, the average recovery was (n = 9) metronidazole 98.8%, tetracycline hydrochloride 98.3 %. Conclusion: The method is sensitive, rapid, accurate, reproducible and can be used for the quality control of this preparation.