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目的:建立梯度洗脱HPLC法同时测定丁丙诺啡纳洛酮舌下片中两种主药的量。方法:采用梯度洗脱,用DiamonsilC18(250mm×4.6mm,5μm)色谱柱;以甲醇-乙腈-0.02mol/L磷酸二氢钾溶液(48:32:20)(用磷酸调pH4.0)为流动相A,甲醇-乙腈-0.02mol/L磷酸二氢钾溶液(6:4:90)(用磷酸调pH4.0)为流动相B;体积流量1.0mL/min;检测波长为230nm。结果:纳洛酮在5.0～30.0μg/mL线性关系良好(r=0.9998),回收率为99.68%(RSD=0.92%);丁丙诺啡在20.0～120.0μg/mL线性关系良好(r=0.9999),回收率为99.74%(RSD=0.53%)。结论:采用梯度洗脱HPLC法同时测定丁丙诺啡纳洛酮舌下片中两主药的量,方法简便、灵敏、专属,重现性好,该方法可以监控药品质量。
Objective: To establish a gradient elution HPLC method for simultaneous determination of two main drugs in buprenorphine naloxone sublingual tablets. Methods: A gradient elution was performed on a Diamonsil C18 column (250 mm × 4.6 mm, 5 μm). The column was eluted with methanol-acetonitrile-0.02 mol / L potassium dihydrogen phosphate solution (48:32:20) Mobile phase A, methanol-acetonitrile-0.02mol / L potassium dihydrogen phosphate solution (6: 4: 90) (adjusted to pH4.0 with phosphoric acid) as mobile phase B; volume flow rate 1.0mL / min; detection wavelength was 230nm. Results: The linear range of naloxone was 5.0 ~ 30.0μg / mL (r = 0.9998), the recovery rate was 99.68% (RSD = 0.92%). The linear relationship between buprenorphine and 20.0 ~ 120.0μg / 0.9999). The recovery rate was 99.74% (RSD = 0.53%). Conclusion: The method of gradient elution HPLC for simultaneous determination of two main drugs in buprenorphine naloxone sublingual tablets is simple, sensitive, specific and reproducible. This method can monitor the quality of drugs.