HPLC法同时测定复方奥美沙坦酯片中3种成分的含量  

Simultaneous Determination of Three Ingredients in Compound Olmesartan Medoxomile Tablets by HPLC

作　　者：刘艳明[1] 王雪芳[2] 

机构地区：[1]解放军251医院心内科,河北张家口075000 [2]河北北方学院医学院生理教研室

出　　处：《中国药师》2015年第11期1989-1991,共3页China Pharmacist

摘　　要：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 x4.6 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pH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=0.9999）范围内,氨氯地平质量浓度在1.0-20.0 mg·L-1（r=0.9999）范围内,氢氯噻嗪质量浓度在1.25-25.0 mg·L-1（r=0.9999）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 an HPLC method for the simultaneous determination of olmesartan medoxomile, amlodipine be-sylate and hydrochlorothiazide in compound olmesartan medoxomile tablets. Methods：The desired chromatographic separation was a-chieved on a Phenomenex C18 （250 mmx. 6 mm, 5μm） column. With gradient elution, the optimized mobile phase consisted of ace-tonitrile as solvent A, and 50 mmol·L-1 potassium dihydrogen phosphate buffer （pH 3. 0, containing 0. 05% triethylamine） as sol-vent B. The flow rate was set at 1. 0 ml·min-1 , the column temperature was 30 ℃, the UV detection was carried out at 236 nm and the sample size was 20μl. Results：The compounds were separated well, the linearity between the peak area and the concentration was observed within the range of 4. 0-80. 0 mg·L-1（r=0. 999 9）for olmesartan medoxomile, 1. 0-20. 0 mg·L-1（r=0. 999 9）for amlo-dipine besylate and 1. 25-25. 0 mg·L-1（r=0. 999 9）for hydrochlorothiazide. The average recovery of olmesartan medoxomile, amlo-dipine besylate and hydrochlorothiazide was 99. 1%（RSD=1. 31%, n=9）, 100. 3%（RSD=1. 21%, n=9） and 100. 2%（RSD=1. 06%, n=9）, respectively. Conclusion：The method is specific and stable in the determination of olmesartan medoxomile, amlo-dipine besylate and hydrochlorothiazide in the tablets.

关 键 词：奥美沙坦酯 苯磺酸氨氯地平 氢氯噻嗪 高效液相色谱法 含量测定 

分 类 号：R927.2[医药卫生—药学]