目的：建立梯度洗脫HPLC法同時測定丁丙諾啡納洛酮舌下片中兩種主藥的量。方法：采用梯度洗脫，用Diamonsil C₁₈（250 mm×4.6 mm，5 μm）色譜柱；以甲醇-乙腈-0.02 mol/L磷酸二氫鉀溶液（48∶32∶20）（用磷酸調(diào)pH 4.0）為流動相A，甲醇-乙腈-0.02 mol/L磷酸二氫鉀溶液（6∶4∶90）（用磷酸調(diào)pH 4.0）為流動相B；體積流量1.0 mL/min；檢測波長為230 nm。結(jié)果：納洛酮在5.0～30.0 μg/mL線性關系良好（r = 0.999 8），回收率為99.68%（RSD＝0.92%）；丁丙諾啡在20.0～120.0 μg/mL線性關系良好（r = 0.999 9），回收率為99.74%（RSD＝0.53%）。結(jié)論：采用梯度洗脫HPLC法同時測定丁丙諾啡納洛酮舌下片中兩主藥的量，方法簡便、靈敏、專屬，重現(xiàn)性好，該方法可以監(jiān)控藥品質(zhì)量。

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 of buprenorphine 5.0-30.0 μg/mL (r = 0.999 8), coefficient of recovery was 99.68% (RSD = 0.92%). The calibration curve was linear in the range of naloxone 20.0-120.0 μg/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 hydrochloride sublingual tablets at the same time. The Methods could be used to monitor drug quality.