RP-HPLC测定甲硝唑阴道泡腾片中甲硝唑含量

Determination of Metronidazole in Metronidazole Vaginal Effervescent Tablet by RP-HPLC

关键词:  甲硝唑  含量测定；反相高效液相色谱法；阴道泡腾片

Key words:  metronidazole  assay  RP-HPLC  vaginal effervescent tablet

摘要:

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（150 mm×4.6 mm，5 μm），以甲醇-水（20∶80）为流动相，流速1.0 mL·min-1，紫外检测器检测波长为320 nm。结果RP-HPLC测定的线性范围为0.13～0.40 mg·mL-1，r＝1.000；样品溶液在24 h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。

Abstract:

OBJECTIVE Establish a RP-HPLC method for the determination of the content of metronidazole in metronidazole vaginal effervescent tablet. METHODS Alltima C18（150 mm×4.6 mm，5μm）was used as the stationary phase. The mobile phase was methanol-water (20∶80). The flow rate was 1.0 mL·min-1, and the detection wavelength was 320 nm. RESULTS The method was proved to be linear in the range of 0.13-0.40 mg·mL-1(r =1.000). The average recovery of the method was 100.1% with RSD=1.0%(n=9). The RSD of average contents of inter and intra-day was 0.7% and 1.2% respectively. CONCLUSIONS This method is simple, rapid, accurate and is suitable for determination of the content of metronidazole in metronidazole vaginal effervescent tablet.