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目的:建立盐酸噻吩诺啡片有关物质检查的HPLC法。方法:用Phenomenex C_(18)(250 mm×4.6 mm,5μm)色谱柱,以甲醇-0.02 mol·L~(-1)磷酸盐缓冲液(pH=3,含0.2%的三乙胺)(60:40)为流动相,检测波长242 nm,流速1.0 ml·min~(-1)。结果:最低检测限为15μg·L~(-1)。盐酸噻吩诺啡与有关物质分离良好。结论:本法灵敏度高、专属性强,可用于盐酸噻吩诺啡片的有关物质检查。
Objective: To establish an HPLC method for the determination of thiophene hydrochloride tablets related substances. METHODS: Phenomenex C_ (18) (250 mm × 4.6 mm, 5 μm) column was used in this study. The mobile phase consisted of 0.02 mol·L -1 phosphate buffer (pH = 3, containing 0.2% triethylamine) 60:40) as the mobile phase. The detection wavelength was 242 nm and the flow rate was 1.0 ml · min ~ (-1). Results: The minimum detection limit was 15μg · L -1. Thienorphine hydrochloride and related substances isolated. Conclusion: This method has high sensitivity and specificity and can be used for the related substances examination of thienorphine hydrochloride tablets.