复方奥硝唑栓的制备及质量控制

Preparation and quality control of compound ornidazole suppository

目的研究复方奥硝唑栓制备工艺及质量控制。方法用高效液相色谱法,20RBA×Eclipse×C8柱（150mm×4.6 mm,5μm）,以甲醇-水-三乙胺（70∶30∶0.3）（含庚烷磺酸钠10 mol·L·mL^-1^-1,用磷酸调pH至4.0）为流动相,检测波长为260 nm,流速为1 mL·min^-1,分别测定奥硝唑、克霉唑的含量。结果奥硝唑在40-240μg·mL^-1,克霉唑在32-192μg·mL^-1线性关系良好,r值分别为0.9998和0.9996,平均回收率分别为99.10%和98.35%。结论复方奥硝唑栓配方合理,制备工艺简单,质控方法可靠,稳定性良好。

Objective To determine the preparation and quality control of compound ornidazole suppository. Methods High pressure Liquid chromatography was used with 20 RBA× Eclipse× DB-C8 （150 mm× 4.6 mm, 5 μm）, with methanol-water- triithlamine （70 ： 30 ： 0.3） （containing G camphatase sulfonic acid 10 mol · L^-1 , pH of phosphatase being 4.0） being the mobile phase and detective wavelength being 260 nm. The flow rate was 1 mL · min^-1 , the contents of ornidazole and clotrimazole were determined respectively. Results Good linear dependence was observed when ornidazole was within 40-240 μg · mL^-1 , clotrimazole within 324192 μg · mL^-1 , r was 0. 9998 and 0. 9996. Meanwhile, the average recovery rate was 99.10%, and 98. 35%. Conclusion Ornidazole with rational formula and simple preparation is reliable and stable in quality control .