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目的:建立测定复方奥美沙坦酯片中3种药物含量的HPLC法。方法:色谱柱:采用菲罗门C18柱(250 mm×4.6 mm,5μm);流动相:A为乙腈,B为磷酸盐缓冲液(50 mmol·L-1磷磷酸二氢钾,加入0.05%三乙胺,用磷酸调节p H至3.0),进行梯度洗脱,流速1.0 ml·min-1;柱温:30℃;检测波长:236 nm;进样量:20μl。结果:奥美沙坦酯质量浓度在4.0~80.0 mg·L-1(r=0.999 9)范围内,氨氯地平质量浓度在1.0~20.0 mg·L-1(r=0.999 9)范围内,氢氯噻嗪质量浓度在1.25~25.0 mg·L-1(r=0.999 9)范围内与峰面积呈良好的线性关系,3种药物平均回收率分别为99.1%(RSD=1.31%,n=9)、100.3%(RSD=1.21%,n=9)和100.2%(RSD=1.06%,n=9)。结论:本方法简便快捷、专属性强、稳定可靠,适用于复方奥美沙坦酯片中的3种药物成分含量的测定。
Objective: To establish a HPLC method for the determination of three drugs in the compound olmesartan medoxomil tablets. Methods: The column was equipped with a Phenomenex C18 column (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile and B buffer (50 mmol·L-1 potassium phosphate monobasic, 0.05% Triethylamine, adjusted to pH 3.0 with phosphoric acid) and gradient elution was performed at a flow rate of 1.0 ml · min -1; column temperature: 30 ° C .; detection wavelength: 236 nm; injection volume: 20 μl. Results: The concentration of olmesartan medoxomil in the range of 4.0-80.0 mg · L-1 (r = 0.999 9) and the concentration of amlodipine in the range of 1.0-20.0 mg · L-1 (r = 0.999 9) The linear relationship between the mass concentration and the peak area was in the range of 1.25-25.0 mg · L-1 (r = 0.999 9). The average recoveries of the three drugs were 99.1% (RSD = 1.31%, n = 9) and 100.3 % (RSD = 1.21%, n = 9) and 100.2% (RSD = 1.06%, n = 9). Conclusion: The method is simple, rapid, specific, stable and reliable. It is suitable for the determination of three kinds of drugs in the compound olmesartan medoxomil tablets.