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目的采用反相高效液相色谱法测定甲硝唑阴道泡腾片中甲硝唑的含量。方法采用Alltima C18色谱柱(150mm×4.6mm,5μm),以甲醇-水(20∶80)为流动相,流速1.0mL·min-1,紫外检测器检测波长为320nm。结果RP-HPLC测定的线性范围为0.13～0.40mg·mL-1,r=1.000;样品溶液在24h内稳定;平均回收率为100.1%,RSD为1.0%(n=9);日内和日间RSD分别为0.7%和1.2%。结论采用RP-HPLC测定甲硝唑阴道泡腾片中甲硝唑的含量,专属性强,结果准确可靠。
Objective To determine the content of metronidazole in metronidazole vaginal effervescent tablets by reversed-phase high performance liquid chromatography. Methods Alltima C18 column (150 mm × 4.6 mm, 5 μm) was used with mobile phase of methanol-water (20:80) as the mobile phase at a flow rate of 1.0 mL · min-1. The UV detection wavelength was 320 nm. Results The linear range of RP-HPLC was 0.13-0.40 mg · mL-1, r = 1.000. The sample solution was stable within 24 h. The average recovery was 100.1% and the RSD was 1.0% (n = 9). The intra- and inter- RSD 0.7% and 1.2% respectively. Conclusion RP-HPLC determination of metronidazole vaginal effervescent tablets metronidazole content, specificity, the results are accurate and reliable.