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目的:建立盐酸消旋山莨菪碱注射液含量及有关物质的HPLC检测方法。方法:采用C18柱(Intersil,ODS-3,4.6 mm×250 mm,5μm);流动相为0.01 mol.L-1磷酸二氢钾溶液(含0.15%三乙胺,用磷酸调pH至6.5)-甲醇(50∶50),流速1.0mL.min-1,检测波长为220 nm。结果:盐酸消旋山莨菪碱与杂质峰能完全分离,盐酸消旋山莨菪碱在0.1234～0.4112 mg.mL-1浓度范围内线性关系良好(r=0.9999),高、中、低3种不同浓度的回收率为99.2%～99.9%(n=9)。结论:本方法操作简便,精密度好,结果准确可靠,可用于该制剂的质量控制。
Objective: To establish an HPLC method for determination of racimil hydrochloride injection and its related substances. Methods: C18 column (Intersil, ODS-3, 4.6 mm × 250 mm, 5 μm) was used. The mobile phase consisted of 0.01 mol·L-1 potassium dihydrogen phosphate solution containing 0.15% triethylamine and adjusted to pH 6.5 with phosphoric acid. -methanol (50:50) at a flow rate of 1.0 mL · min-1. The detection wavelength was 220 nm. Results: Anisodamine hydrochloride was completely separated from impurity peaks. Aniline anisodamine hydrochloride showed a good linearity (r = 0.9999) within the range of 0.1234 ~ 0.4112 mg.mL-1, with high, medium and low The recovery of the concentration ranged from 99.2% to 99.9% (n = 9). Conclusion: The method is simple, accurate, accurate and reliable, and can be used for the quality control of the preparation.