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机构地区:[1]哈尔滨大中制药有限公司,黑龙江哈尔滨150060
出 处:《中国药业》2007年第9期18-19,共2页China Pharmaceuticals
摘 要:目的建立测定注射用盐酸维拉帕米含量的高效液相色谱法。方法采用C18色谱柱(150mm×4.6mm,5μm),以醋酸-醋酸钠溶液-甲醇-三乙胺(55∶45∶1)为流动相,检测波长为278nm。结果盐酸维拉帕米进样量在1.0~10.0μg范围内与峰面积线性关系良好,r=0.9998,平均回收率为99.75%,RSD为0.93%。结论高效液相色谱法精密可靠,可作为注射用盐酸维拉帕米的质量控制方法。Objective To establish a method for the determination of verapamil hydrochlofid for injection by HPLC. Methods HPLC conditions: C18 column (150 mm ×4. 6 mm,5μm) ,column temperature was 40℃ ,acetic acid -sodium acetate (using sodium acetate 1.36 g, dissolving with fight amount water,adding acetic acid 33 mL,adding fight amount water to 1 000mL)-methanol-triethylamine (55:45:1) as the mobile phase,278 nm as the detective wavelength. Results The linear range of verapamil hydrochlofide was 1.0- 10.0 μg, r =0. 999 8. The average recovery rate was 99.75%, RSD was 0.93%. Conclusion This method is precise and credible. It can be applied to the quality control of verapamil hydrochloride for injection.
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