HPLC法测定丁丙诺啡纳洛酮舌下片中两种主药的量

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。

Determination of content of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets by gradient HPLC

Objective：To establish agradient elution HPLC method for determination of the contents of buprenorphine hydrochloride and naloxone hydrochloride sublingual tablets at the same time.Methods：The column was Diamonsil C18（250 mm×4.6 mm,5 μm）.Mobile phase A was methanol：acetonitrile：0.02mol/L potassium dihydrogen phosphate buffer（48：32：20）（pH 4.0）;Mobile phase B was methanol：acetonitrile：0.02 mol/L potassium dihydrogen phosphate buffer（6：4：90）（pH 4.0）.Flow rate was 1.0 mL/min.Detection wavelength was. 314 nm. Results： The calibration curve was linear in the range ofbuprenorphine 5.0-30.0 Ixg/mL （r = 0.999 8）, coefficient of recovery was 99.68% （RSD = 0.92%）. The calibration curve was linear in the range ofnaloxone 20.0-120.0 ~tg/mL （r = 0.999 9）, coefficient of recovery was 99.74% （RSD = 0.53%）. Conclusion： The method is simple, sensitive, specific, reproducible, accurate and suitable for examination of the contents of buprenorphine hydrochloride and naloxone hydroehloride sublingual tablets at the same time. The Methods could be used to monitor drug quality.