替硝唑含片的高效液相色谱法测定Assaying determination of Tinidazole Buccal Tablets by HPLC
陈卫,梁勇军,陆琴
CHEN Wei, LIANG Yong-jun, LU Qin (China Associate Pharmaceutical Co.
摘要(Abstract):
目的建立替硝唑含片含量的高效液相色谱法(HPLC)测定法。方法采用KromasilC18色谱柱,甲醇-水-冰醋酸(20︰80︰0.1)为流动相,柱温35℃,流速1.0ml/min,检测波长为317nm,进样20μl。结果样品替硝唑浓度在9.91~80.19mg/L呈良好线性关系,相关系数r=0.9999;平均回收率101.5%(n=9),相对标准偏差(RSD)为0.84%。结论HPLC法测定替硝唑含片的含量,灵敏度高,操作方便、可行,可用于产品质量控制。
Objective To establish a HPLC method for the determination of tinidazole buccal tabs. Methods Chromatographic condition of included ODS C18 Kromasil (5 μm, 150 mm×4.6 mm) column and mobile phase of a mixture of methanol-water-acetic acid (20︰80︰0.1) was adopted. The detection wavelength was 317 nm. The flow rate was 1.0 ml/min. The injection volume was 20 μl. Results The method has a good linearity and correlation coefficient: the linear range was between 9.91~80.19 mg/L (r =0.9999). The recovery was 101.5% (n =9), RSD was 0.84%. Conclusion This method is a simple, rapid, and accurate assay, and suitable for quality control of large amounts of samples.
关键词(KeyWords):
替硝唑含片;含量;高效液相色谱法;测定
Tinidazole buccal tabs; assay; HPLC; determination
基金项目(Foundation):
作者(Author):
陈卫,梁勇军,陆琴
CHEN Wei, LIANG Yong-jun, LU Qin (China Associate Pharmaceutical Co.