hplc -密度法测定复方氯噻酮、琥珀酸美托洛尔和替米沙坦的含量

IF 1.8 Q3 CHEMISTRY, ANALYTICAL Journal of Chemical Metrology Pub Date : 2022-12-15 DOI:10.25135/jcm.77.2208.2546
Avani Chokshi, R. Prajapati, Pritesh Desai, Niraj Vyas
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引用次数: 1

摘要

:本研究显示了对原料药和市售制剂中氯噻酮(CHL)、琥珀酸美托洛尔(MET)和替米沙坦(TEL)的非常简单、快速和精确的高效薄层色谱(HPTLC)-密度测定结果的汇编。样品的色谱分离在硅胶60 F254铝板上进行,使用甲苯:甲醇:乙酸乙酯:三乙胺作为流动相,体积比为4:0.8:1:1.2。使用CAMAG TLC Scanner-IV在225nm波长下进行密度扫描。所述色谱系统显示CHL、MET和TEL的紧密带和对称峰,延迟因子(Rf)分别为0.40(±0.2)、0.69(±0.26)和0.27(±0.27)。所报道的方法在500-2000纳克/带、1000-400纳克/带和1600-6400纳克/带的浓度范围内呈线性,而CHL、MET和TEL的回收率分别在98.94-99.62%、98.26-98.41%和99.86-100.28%之间。该方法测定了上市制剂的CHL含量为99.89(±0.91),MET含量为98.92(±1.07),TEL含量为100.12(±0.65)。所有结果表明,所开发的方法符合ICH Q2(R1)指南,并适用于联合药物制剂中这些药物的日常分析。
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HPTLC- Densitometric method for assay of chlorthalidone, metoprolol succinate and telmisartan in combined pharmaceutical formulation
: The present study shows the compilation of the results obtained for a very simple, fast and precise high-performance thin-layer chromatography (HPTLC) - densitometric determination of chlorthalidone (CHL), metoprolol succinate ( MET) and telmisartan ( TEL) in bulk drugs as well as the commercially available formulation. The chromatographic separation of samples was performed on Silica Gel 60 F254 aluminum sheets using Toluene: Methanol: Ethyl acetate: Tri-ethylamine as the mobile phase in the volume ratio 4:0.8:1: 1.2. The densitometric scanning was performed at 225 nm wavelength using CAMAG TLC Scanner- IV. The mentioned chromatographic system showed the compact band and symmetrical peaks of CHL, MET and TEL with 0.40 (±0.2), 0.69 (±0.2) and 0.27 (±0.2) retardation factor (Rf) respectively. The reported method is linear in the concentration range of 500-2000 ng/band, 1000-4000 ng/band and 1600-6400 ng/band while the recovery was found in the range of 98.94-99.62%, 98.26-98.41% and 99.86-100.28% for CHL, MET and TEL respectively. The method assayed the marketed formulation with 99.89 (±0.91) for CHL, 98.92 (±1.07) for MET and 100.12 (±0.65) for TEL concerning the label claim. All the results suggested the agreement of the developed method to the ICH Q2(R1) guidelines and its applicability for day-to-day analysis of these drugs in combined pharmaceutical formulations.
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来源期刊
Journal of Chemical Metrology
Journal of Chemical Metrology CHEMISTRY, ANALYTICAL-
CiteScore
2.30
自引率
15.40%
发文量
7
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