A New Stability Indicating RP-HPLC Method for Determination of Chlorthalidone, Telmisartan and Cilnidipine in Bulk and Tablet Dosage Form

S. Sultana, P. Salomi, T. Vimalakkannan, K. Reddy
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Abstract

In present study, accurate, precise, rapid and sensitive stability indicting HPLC-UV method has been established for quantification of Telmisartan, Cilnidipine and Chlorthalidone simultaneously in Tablet and bulk. Telmisartan, Cilnidipine and Chlorthalidone were resoluted on Sunsil C18 column (4.6mmx250mm; 5μm) using mobile phase containing Acetonitrile and Potassium dihydrogen phosphate in 50:50(v/v) ratio with flow rate of 1ml/min at 238 nm. Concentrations were linear over the range of 40-120 μg/ml for Telmisartan, 10-30 μg/ml for Cilnidipine and 6.25-18.75 μg/ml for Chlorthalidone. The percentage recovery was found to be 99.70-100.51% for Telmisartan, 98.41-100.49% for Cilnidipine and 99.34-100.48% for Chlorthalidone. % RSD for peak area was 0.069% for Telmisartan, 0.058% for Cilnidipine and 0.057% for Chlorthalidone shows that the proposed method is precise. Force-degradation studies have not shown any observable change in the results and hence the proposed method is stability indicating and hence the method is suitable for routine analysis of Telmisartan, Cilnidipine and Chlorthalidone in bulk and tablet dosage form.
稳定性指示反相高效液相色谱法测定氯噻酮、替米沙坦、西尼地平原料药和片剂的含量
本研究建立了准确、精确、快速、灵敏、稳定的高效液相色谱-紫外分光光度法同时定量替米沙坦、西尼地平和氯噻酮片剂和散装药。替米沙坦、西尼地平和氯噻酮在Sunsil C18色谱柱(4.6mmx250mm;5μm),以乙腈和磷酸二氢钾为流动相,以50:50(v/v)比,流速为1ml/min,波长为238 nm。替米沙坦在40 ~ 120 μg/ml、西尼地平在10 ~ 30 μg/ml、氯噻酮在6.25 ~ 18.75 μg/ml范围内呈线性关系。替米沙坦回收率为99.70 ~ 100.51%,西尼地平回收率为98.41 ~ 100.49%,氯噻酮回收率为99.34 ~ 100.48%。替米沙坦、西尼地平和氯噻酮的峰面积RSD分别为0.069%、0.058%和0.057%。力降解研究未发现任何可观察到的结果变化,因此所提出的方法具有稳定性,因此该方法适用于替米沙坦、西尼地平和氯噻酮的散装和片剂的常规分析。
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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