Simultaneous estimation of olmesartan medoxomil and indapamide from bulk and commercial products using a validated reverse phase high performance liquid chromatographic technique

A. Sheth, K. Patel, R. Badmanaban, N. Doshi, N. Shah
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引用次数: 4

Abstract

Aim: A simple, rapid, accurate, precise and economical reverse phase high performance liquid chromatographicmethod is developed for simultaneous separation and quantification of two anti-hypertensive drugs, viz., olmesartan medoxomil and indapamide. Materials and Methods: The separation of both the drugs was achieved on ACE C 18 AR column (250 × 4.6 mm id, 5 μm particle size) column using a mobile phase of sodium perchlorate and triethylamine buffer solution (at pH 3): Acetonitrile (60:40 v/v). The flow rate was 1 ml/min and detection was done at 280 nm. Results: The retention time for indapamide was 5.3 min and for olmesartan medoxomil was 6.8 min. Olmesartan medoxomil and indapamide showed a linear response in the concentration range of 50-300 μg/ml and 3.75-22.5 μg/ml respectively. The correlation co-efficients for olmesartan medoxomil and indapamide were 0.9999 and 0.9998 respectively. The percentage recoveries obtained forolmesartan medoxomil and indapamide ranges from 99.3% to 99.8% and 99.7% to 100.9% respectively. The results of the analysis have been validated as per International conference on Harmonisation (ICH) guidelines. Validation results indicated that method shows satisfactory linearity, accuracy, precision, and ruggedness. Conclusion: The extremely low flow rate, simple mobile phase composition makes this method cost effective, rapid, and non-tedious and can also be successfully employed for simultaneous estimation of both drugs in commercial products.
使用有效的反相高效液相色谱技术同时估计散装和商业产品中的奥美沙坦美多索米和吲达帕胺
目的:建立一种简便、快速、准确、精密度高、经济的反相高效液相色谱同时分离、定量两种降压药奥美沙坦美多索米和吲达帕胺的方法。材料与方法:两种药物在ACE C 18 AR柱(250 × 4.6 mm id, 5 μm粒径)上分离,流动相为高氯酸钠-三乙胺缓冲溶液(pH 3):乙腈(60:40 v/v)。流速为1 ml/min,检测波长为280 nm。结果:吲达帕胺的保留时间为5.3 min,奥美沙坦美多索米的保留时间为6.8 min,奥美沙坦美多索米和吲达帕胺在50 ~ 300 μg/ml和3.75 ~ 22.5 μg/ml范围内呈线性关系。奥美沙坦与吲达帕胺的相关系数分别为0.9999和0.9998。回收率为99.3% ~ 99.8%,吲达帕胺为99.7% ~ 100.9%。分析结果已根据国际协调会议(ICH)指南进行验证。验证结果表明,该方法具有良好的线性度、准确度、精密度和耐用性。结论:该方法具有流速极低、流动相组成简单、成本低、快速、不繁琐等优点,可成功用于两种药物在商品中的同时测定。
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