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目的:制备复方异烟肼凝胶剂并建立质量控制的方法。方法:以异烟肼和盐酸左氧氟沙星为主药,卡泊姆为基质制备凝胶剂。采用高效液相色谱法同时测定异烟肼和盐酸左氧氟沙星的含量并进行稳定性试验。结果:异烟肼和盐酸左氧氟沙星均在2～20μg·ml~(-1)的范围内线性良好(r=0.999 8),平均回收率分别为99.51%和99.70%。结论:该制剂制备工艺可行,凝胶性质稳定,质控方法准确、可靠。
Objective: To prepare compound isoniazid gel and to establish a quality control method. Methods: Isoniazid and levofloxacin hydrochloride as the main drug, carbomer gel preparation. Simultaneous determination of isoniazid and levofloxacin hydrochloride by high performance liquid chromatography and stability test. Results: Both isoniazid and levofloxacin hydrochloride showed good linearity (r = 0.999 8) in the range of 2 ~ 20μg · ml ~ (-1) and the average recoveries were 99.51% and 99.70%, respectively. Conclusion: The preparation process is feasible, the gel is stable, the quality control method is accurate and reliable.