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目的:建立丁丙诺啡贴剂中丁丙诺啡含量和体外透皮释放量的HPLC分析方法。方法:采用Waters Symmetry(C18(150mm×4.6mm,5μm)色谱柱,流动相:甲醇-0.02mol.L-1缓冲盐溶液(20mmol·L-1醋酸铵溶液,氨水调节pH=4.5)(50∶50),流速1.0mL·min-1,检测波长286nm。结果:在2.0~10.0μg·mL-1的浓度范围内呈良好的线性关系,r=0.9999。方法的平均回收率在99.9%~100.3%;日内和日间RSD分别小于0.38%和0.98%。最小检测浓度为0.2μg.mL-1。结论:该方法准确、可靠、灵敏度高,适用于丁丙诺啡贴剂的定量检测。
OBJECTIVE: To establish an HPLC method for the determination of buprenorphine and transdermal delivery in buprenorphine patch. METHODS: The mobile phase consisted of methanol-0.02mol.L-1 buffered saline solution (20mmol·L-1 ammonium acetate solution, pH = 4.5 in aqueous ammonia) (50 : 50), the flow rate was 1.0 mL · min-1, the detection wavelength was 286 nm.Results: The linear range was 2.0 ~ 10.0 μg · mL-1, r = 0.9999.The average recovery was 99.9% 100.3% .The intra-day and inter-day RSD were less than 0.38% and 0.98% respectively.The minimum detection concentration was 0.2μg.mL-1 Conclusion: The method is accurate, reliable and sensitive and suitable for the quantitative detection of buprenorphine patches.