Development and validation of UV Spectrophotometric method for simultaneous equation of Aspirin and Omeprazole in tablet dosage form

ip S. Chaudhari, Swapnil D. Phalak
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引用次数: 3

Abstract

YOSPRALA is newly designed tablet which effective in cardiovascular as well as gastrointestinal protection due to its immediate release of Omeprazole (40 mg) and delayed release of Aspirin (81 mg) or (325 mg) dose strength. Yosprala was approved by USFDA in Sept 2016 for cardiovascular and cerebrovascular diseases. Aspirin is an antiplatelet agent & Omeprazole is proton pump inhibitor therefore it is made to develop a new analytical method for Simultaneous estimation of Aspirin and Omeprazole using Mehtanol as a solvent on the basis of solubility. The maximum Absorption (λ max) of Aspirin and Omeprazole was found at 276 and 301 respectively. Linearity range for aspirin was given at 10-50 μg/ml with %RSD value 0.997 and Omeprazole was 2-10 μg/ml with %RSD value 0.997. The method was validated for precision and % RSD was found less than 2.0 for both aspirin and omeprazole. The proposed method was statistically validated for standard deviation, relative standard deviation, coefficient of variance and the results were within the range. Hence the above method was simple, cheap, cost effective, economical, and robust.
紫外分光光度法测定片剂剂型中阿司匹林和奥美拉唑的联立方程的建立与验证
YOSPRALA是一种新设计的片剂,由于其奥美拉唑(40毫克)的立即释放和阿司匹林(81毫克)或(325毫克)剂量强度的延迟释放,对心血管和胃肠道保护有效。Yosprala于2016年9月获得美国fda批准,用于治疗心脑血管疾病。阿司匹林是一种抗血小板药物,奥美拉唑是质子泵抑制剂,因此建立了一种以甲醇为溶剂同时测定阿司匹林和奥美拉唑溶解度的新分析方法。阿司匹林和奥美拉唑的最大吸收λ max分别为276和301。阿司匹林在10 ~ 50 μg/ml范围内线性,%RSD值0.997;奥美拉唑在2 ~ 10 μg/ml范围内线性,%RSD值0.997。方法精密度较高,阿司匹林和奥美拉唑的RSD均小于2.0。对该方法进行了标准差、相对标准差、方差系数的统计验证,结果均在范围内。因此,该方法简单、廉价、经济、可靠。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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