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目的:建立复方氟西汀奥氮平胶囊中药物含量测定的HPLC法。方法:采用菲罗门C18色谱柱(250 mm×4.6 mm,5μm),以10 mmol·L~(-1)磷酸二氢钾溶液(p H 4.0)-乙腈-甲醇(55∶40∶5,v/v/v)为流动相,流速1.0 ml·min~(-1),检测波长227nm,柱温30℃,进样量20μl。结果:氟西汀和奥氮平可达到较好分离,氟西汀质量浓度在5.0~80.0 mg·L~(-1)(r=0.999 9)内,奥氮平质量浓度在1.2~19.2 mg·L~(-1)内(r=0.999 9)与峰面积呈良好的线性关系,平均回收率分别为99.9%(RSD=0.94%,n=9)、100.2%(RSD=2.08%,n=9)。结论:本方法简便、快速、准确,重复性好,可用于复方氟西汀奥氮平胶囊中药物含量测定。
Objective: To establish a HPLC method for the determination of the drug content in compound fluoxetine olanzapine capsules. Methods: The reaction was performed on a Phenomenex C18 column (250 mm × 4.6 mm, 5 μm) with 10 mmol·L -1 potassium dihydrogen phosphate solution (p H 4.0) -acetonitrile-methanol (55:40:5, v / v / v) as the mobile phase at a flow rate of 1.0 ml · min ~ (-1) at a detection wavelength of 227 nm at a column temperature of 30 ° C. Results: Fluoxetine and olanzapine could be separated well. The concentration of fluoxetine was 5.0-80.0 mg · L -1 (r = 0.999 9), the concentration of olanzapine was 1.2-19.2 mg · There was a good linear relationship between peak area and L -1 (r = 0.999 9). The average recoveries were 99.9% (RSD = 0.94%, n = 9), 100.2% (RSD = 2.08%, n = 9). Conclusion: The method is simple, rapid, accurate and reproducible. It can be used for the determination of the drug content of compound fluoxetine olanzapine capsules.