A NOVEL METHOD DEVELOPMENT FOR THE ESTIMATION OF IRBESARTAN IN TABLETS BY USING REVERSE PHASE LIQUID CHROMATOGRAPHY

S. Satyasri
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Abstract

A simple, sensitive, accurate method was developed for the estimation of Irbesartan in tablets by RP-HPLC technique. Chromatographic conditions used are stationary phase standard ODS (150 mm x 4.6 mm, 5) column, mobile phase was orthophosphate buffer: methanol in the ratio of (50:50,v/v) and flow rate was maintained at 1 ml/min, detection wave length was 258 nm, column temperature was set to 30 o C and diluent was mobile phase conditions were finalized as optimized method. System suitability parameters were studied by injecting the standard six times and results were well under the acceptance criteria. Linearity study was carried out between 37.5 to 225 μg/ml levels, R 2 value was found to be as 0.999. Precision was found to be 1.3 for repeatability and 0.8 for intermediate precision. LOD and LOQ are 0.205 μg/ml and 0.623 μg/ml, respectively. By using above method assay of marketed formulation was carried out 99.89% was present.
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建立了反相液相色谱法测定厄贝沙坦片剂含量的新方法
建立了简便、灵敏、准确的反相高效液相色谱法测定厄贝沙坦片剂中厄贝沙坦含量的方法。色谱条件为固定相标准ODS (150 mm × 4.6 mm, 5)柱,流动相为正磷酸盐缓冲液:甲醇,比例为(50:50,v/v),流速为1 ml/min,检测波长为258 nm,柱温为30℃,流动相为稀释液,确定最佳色谱条件。通过注入6次标准液,对系统适宜性参数进行了研究,结果完全符合验收标准。在37.5 ~ 225 μg/ml浓度范围内进行线性研究,r2值为0.999。重复性精密度为1.3,中间精密度为0.8。定量限和定量限分别为0.205 μg/ml和0.623 μg/ml。采用该方法对市售制剂进行了检测,回收率达99.89%。
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