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目的:建立测定盐酸奥布卡因凝胶含量及其有关物质的高效液相色谱法。方法:采用Agilent C18色谱柱(200 mm×4.6 mm,5μm),以乙腈-pH 2.5缓冲液(6 ml高氯酸、12 ml磷酸加950 ml水,用5 mol.L-1氢氧化钠调pH至2.5,用水稀释至1 000 ml)(30∶70)为流动相,流速为1.0 ml.min-1,检测波长为309 nm,柱温30℃。结果:盐酸奥布卡因与其相邻杂质峰能完全分离,在7.811～234.33μg.ml-1范围内与峰面积线性关系良好(r=1.000 0),平均回收率为101.3%(RSD=0.7%,n=9);最低检出量为0.3 ng。结论:本法专属性强,准确可靠,可用于盐酸奥布卡因凝胶的质量控制。
Objective: To establish a HPLC method for the determination of the content of AchIbine hydrochloride gel and its related substances. Methods: Agilent C18 column (200 mm × 4.6 mm, 5 μm) was used with acetonitrile-pH 2.5 buffer (6 ml of perchloric acid, 12 ml of phosphoric acid plus 950 ml of water and 5 mol·L -1 sodium hydroxide pH = 2.5 and diluted to 1000 ml with water (30:70) as the mobile phase at a flow rate of 1.0 ml.min-1 at a detection wavelength of 309 nm at a column temperature of 30 ° C. Results: The results showed that the concentration of buprenorphine hydrochloride was completely separated from the adjacent impurity peak, and the peak area was linear (r = 1.000 0) in the range of 7.811 ~ 234.33μg.ml-1 with an average recovery of 101.3% (RSD = 0.7 %, n = 9); the minimum detectable amount was 0.3 ng. Conclusion: This method is specific, accurate and reliable, and can be used for the quality control of Aconcagin Hydrochloride gel.