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首页> 外文期刊>Der Pharma Chemica: journal for medicinal chemistry, pharmaceutical chemistry and computational chemistry >Validated RP-HPLC Method for the Determination of Indapamide in Bulk and Tablet Dosage Form
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Validated RP-HPLC Method for the Determination of Indapamide in Bulk and Tablet Dosage Form

机译：经验证的RP-HPLC法测定散装和片剂剂量形式的吲达帕胺

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摘要

A novel, simple and economic reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the estimation of Indapamide in bulk and tablet dosage form with greater precision and accuracy. Separation was achieved on C18 column (250X4.6mm i.d.,5μm) in isocratic mode using Acetonitrile:Methanol:Water in the ratio of 40:50:10 (v/v/v) as mobile phase, pumped in to the column at flow rate of 1.0 mL min−1and the detection of eluent from the column was carried out using variable wavelength UV detector at 242 nm. The total run time was 10 min and the column was maintained at ambient temperature. The retention time of Indapamide was 3.233 min. The standard curves were linear over the concentration range of 10-60 μg mL−1 with R2 9995 and the LOD and LOQ values for Indapamide were 0.52 μg mL−1and 0.78 μg mL−1, respectively. The percentage recovery was found to be 98.16 – 100.12%, the % RSD of intraday and inter day precision was found to be 0.4404 and 0.5588, respectively. The percentage amount of a marketed tablet formulation of Indapamide was found to be 99.12 %. The method was validated as per ICH guidelines. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible. Hence the proposed method can be applied for the routine quality control analysis of Indapamide in bulk and tablet dosage forms.
机译：开发了一种新颖，简单，经济的反相高效液相色谱（RP-HPLC）方法，用于以更高的精度和准确性估算散装和片剂剂型的吲达帕胺。使用乙腈：甲醇：水以40:50:10（v / v / v）的比例作为流动相，在等度模式下在C18色谱柱（250X4.6mm内径，5μm）上实现分离，并以流速将其泵入色谱柱流速为1.0 mL min-1并使用242 nm可变波长UV检测器检测色谱柱中的洗脱液。总运行时间为10分钟，色谱柱保持在环境温度下。吲达帕酰胺的保留时间为3.233分钟。标准曲线在R2 9995的10-60μgmL-1浓度范围内是线性的，吲达帕胺的LOD和LOQ值分别为0.52μgmL-1和0.78μgmL-1。回收率百分比为98.16 – 100.12％，日内和日间精度的RSD％分别为0.4404和0.5588。发现市售的吲达帕胺片剂的百分数为99.12％。该方法已按照ICH指南进行了验证。验证研究表明，所提出的RP-HPLC方法简单，专一，快速，可靠且可重现。因此，所提出的方法可以用于散装和片剂剂型吲达帕胺的常规质量控制分析。

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