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目的:建立复方林可霉素滴耳液的含量测定方法。方法:采用高效液相色谱法变换检测波长的方法。结果:保留时间0~7min时,以214nm作为检测波长,测定盐酸林可霉素,测得线性范围为1.228~12.278g.L-1(r=0.999 7),平均回收率为99.68%;保留时间7~14min时,以241nm作为检测波长,测定地塞米松磷酸钠,测得线性范围为9.98~99.75mg.L-1(r=0.999 8),平均回收率为98.01%。结论:所用方法灵敏、准确,可作为该产品质量控制的方法。
Objective: To establish a method for determination of compound lincomycin ear drops. Methods: High performance liquid chromatography method of detection wavelength. Results: When the retention time was 0 ~ 7min, the detection wavelength of 214nm was lincomycin hydrochloride. The linear range was 1.228 ~ 12.278gL-1 (r = 0.999 7) with the average recovery of 99.68%. The retention time of 7 ~ 14min, with 241nm as the detection wavelength, the dexamethasone sodium phosphate was determined. The linear range was 9.98 ~ 99.75mg.L-1 (r = 0.999 8). The average recovery was 98.01%. Conclusion: The method used is sensitive and accurate, which can be used as the quality control method of this product.