Analytical high performance liquid chromatography method for estimating the combination of aspirin and omeprazole in bulk and tablet dosage form
Analytical high performance liquid chromatography method for estimating the combination of aspirin and omeprazole in bulk and tablet dosage form
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DOI：
10.12991/jrp.2018.91
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发表时间：
2018-01-01
影响因子：
0.8
通讯作者：
Navuluri, Srinivasu
中科院分区：
文献类型：
--
作者：
Yenduri, Gopikrishna;Navuluri, Srinivasu
建立了同时测定原料药和片剂中阿司匹林和奥美拉唑含量的高效液相色谱法。以0.1M磷酸二氢钾-乙腈(55：45v/v)为流动相，在pH为4.5的条件下，成功地对所选药物进行了分析。选用Zodiac C18(150×3.0 mm，5µm)色谱柱。奥美拉唑和阿司匹林的线性范围分别为0.08~24mU/ml和0.65~195mU/ml，检出限和检出限分别为：阿司匹林0.199 mU/ml和0.65 mU/ml，奥美拉唑0.024 mU/ml和0.080 mU g/ml。阿司匹林和奥美拉唑的回收率分别为99.75%~99.92%和99.46%~99.57%。阿司匹林和奥美拉唑的相对标准偏差分别为0.083%~0.085%和0.045%~0.047%。根据ICH指南对片剂样品进行强制降解研究(如碱性、酸性、氧化、热和光解条件)。降解物的峰与阿司匹林和奥美拉唑的主峰很好地分开。该方法成功地用于阿司匹林和奥美拉唑制剂中阿司匹林和奥美拉唑的含量测定，无普通辅料干扰。
A HPLC method was developed for the estimation of aspirin and omeprazole simultaneously in bulk drug and tablet dosage forms. 0.1 M potassium dihydrogen phosphate and acetonitrile in the ratio of 55:45 v/v at pH of 4.5 was used successfully as the mobile phase for the analysis of the selected drugs. Analysis of the selected drugs was carried out using Zodiac C18 (150 x 3.0 mm, 5 mu m) column. The calibration range for omeprazole was 0.08-24 mu g/ml, whereas, for aspirin was 0.65-195 mu g/ml. The LOD and LOQ values were; 0.199 mu g/ml and 0.65 mu g/ml for aspirin, 0.024 mu g/ml and 0.080 mu g/ml for omeprazole, respectively. The percentage recovery of aspirin and omeprazole was found to be 99.75%-99.92% and 99.46%-99.57%, respectively. Percentage relative standard deviation (RSD%) was found to be in the range of 0.083%-0.085% for aspirin and 0.045%-0.047% for omeprazole. Forced degradation studies (such as alkaline, acidic, oxidative, thermal and photolytic degradation conditions) were performed on tablet sample as per the ICH guidelines. The peaks of degradants are well separated from the main peaks of aspirin and omeprazole. The proposed HPLC method was successfully applied for the quantification of aspirin and omeprazole in its pharmaceutical dosage forms without interference from common excipients.