A new analytical method development and validation for the estimation of Midodrine HCl by UV and HPLC

Vijeta Dhote, P. Jain, V. Jain
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引用次数: 3

Abstract

http://dx.doi.org/10.21276/IJRDPL.22780238.2018.7(4).3060-3070 ABSTRACT:Two simple, accurate, sensitive and precise reverse phase-high performance liquid chromatographic and U.V. assay method for estimation of Midodrine hydrochloride (MD) was developed in tablet formulation. The chromatographic separation was performed on Thermo C18, (250 mm X 4.6 mm, 5 μm) column. The mobile phase consists of water: acetonitrile (30:70 v/v) pH adjust 3.5 with TEA was delivered at a flow rate of 1.0 ml/min and UV detection at 272 nm. The retention time of the drug was found to be 3.89 min. The developed method was found to be linear in a concentration range of 5-25μg/ml of the drug (r2= 0.999). The low value of % RSD indicates reproducibility of the methods. The low value of LOD and LOQ suggests the sensitivity of the method. Thus, this method can be used for routine analysis of Midodrine hydrochloride formulation and to check the stability of bulk samples.
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建立了一种新的紫外-高效液相色谱法测定盐酸米多德林的分析方法
http://dx.doi.org/10.21276/IJRDPL.22780238.2018.7(4).3060-3070摘要:建立了两种简便、准确、灵敏、精确的反相高效液相色谱法和紫外分光光度法测定盐酸米多德林(MD)片剂含量的方法。色谱柱为Thermo C18 (250 mm X 4.6 mm, 5 μm)。流动相为水:乙腈(30:70 v/v), pH调为3.5,以TEA为溶剂,流速1.0 ml/min,紫外检测波长272 nm。该方法在5 ~ 25μg/ml的浓度范围内呈良好的线性关系(r2= 0.999)。% RSD值较低表明该方法具有重复性。定量限和定量限均较低,表明该方法的灵敏度较高。该方法可用于盐酸米多德林制剂的常规分析和原料药的稳定性检验。
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