HPLC法测定盐酸消旋山莨菪碱注射液的含量及有关物质

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,5 μm);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1.0 mL·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 the determination of assay and related substances of raceanisodamine hydrochloride injection. Methods: The chromatograph was equipped with a C₁₈ column(Intersil,ODS-3,4.6 mm×250 mm,5 μm),with mobile phase of a mixture of 0.01 mol·L^-1 potassium dihydrogen phosphate solution(with 0.15% triethylamine,adjust pH to 6.5 with phosphoric acid) and methanol(50∶ 50),flow rate of 1.0 mL·min^-1 and detection wavelength at 220 nm. Results: The data show that this method can clearly separate Raceanisodamine peak from its impurity peaks,with a better linear range of 0.1234-0.4112 mg·mL^-1 (r=0.9999),and average recovery range of 99.2%-99.9% during tests in its high,middle and lower concentrations (n=9). Conclusion: This method is simple,accurate and reliable,so it can be used for quality control of this preparation.