HPTLC Method Development and Validation for the Simultaneous Estimation of Nortriptyline HCl and Pregabalin in their Combined Dosage Form.

IF 1.5 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS Journal of chromatographic science Pub Date : 2024-11-01 DOI:10.1093/chromsci/bmad081

Hinal Harkhani, Kashyap Thummar, Sanjay Chauhan, Jigna Vadalia

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Abstract

Nortriptyline HCl and pregabalin Tablet is used to treat neuropathic pain as well as mental or mood issues such as sadness, mood, feelings, anxiety and tensions. Very few analytical methods are available for the simultaneous estimation of nortriptyline HCl and pregabalin and no reports has been found for HPTLC method. In the current study, a reliable HPTLC method for the simultaneous measurement of nortriptyline HCl and pregabalin in pure forms and pharmaceutical formulations has been developed with ninhydrine post derivatization of pregabalin. The HPTLC method development was carried using silica gel G60 F254 as stationary phase and acetonitrile: methanol: triethylamine: water: formic acid (7:3:0.3:0.8:0.02 v/v/v/v/v) was used as mobile phase with saturation time of 20 min. The system was found to give a compact band for nortriptyline HCl (Rf = 0.523 ± 0.008) pregabalin (Rf = 0.279 ± 0.005). The developed method was found to be validated as per ICH Q2 (R1) guideline. The peak of nortriptyline HCl and pregabalin showed good linearity over the concentration range of 50-300 ng/band and 350-2250 ng/band, respectively, with a correlation coefficient of ˃0.995. The % recoveries of both drugs were found to be in the range of 98.84-101.87%. Statistical analysis proved that the method is selective, precise, robust and accurate for the estimation of nortriptyline HCl and pregabalin.

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同时测定盐酸去甲替林和普瑞巴林联合剂型的高效薄层色谱法的建立和验证。

盐酸去甲替林和普瑞巴林片用于治疗神经性疼痛以及精神或情绪问题，如悲伤、情绪、感觉、焦虑和紧张。很少有分析方法可用于同时测定盐酸去甲替林和普瑞巴林，也没有关于HPTLC方法的报道。在目前的研究中，已经开发了一种可靠的HPTLC方法，用于同时测量纯形式和药物制剂中的盐酸去甲替林和普瑞巴林，该方法使用普瑞巴林的茚后衍生化。以硅胶G60 F254为固定相，乙腈：甲醇：三乙胺：水：甲酸（7:3:0.3:0.8:0.02v/v/v/v）为流动相，饱和时间20min，进行HPTLC法的建立。发现该系统对盐酸去甲三丁基林（Rf = 0.523 ± 0.008）普瑞巴林（Rf = 0.279 ± 0.005）。发现所开发的方法根据ICH Q2（R1）指南进行了验证。盐酸去甲替林和普瑞巴林的峰分别在50-300纳克/带和350-2250纳克/带的浓度范围内表现出良好的线性，相关系数为0.995。两种药物的回收率在98.84-101.87%之间。统计分析表明，该方法对盐酸去甲替林和普瑞巴林的含量测定具有选择性、精密性、稳健性和准确性。

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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来源期刊

Journal of chromatographic science 化学-分析化学

CiteScore

2.90

自引率

7.70%

发文量

审稿时长

5.6 months

期刊介绍： The Journal of Chromatographic Science is devoted to the dissemination of information concerning all methods of chromatographic analysis. The standard manuscript is a description of recent original research that covers any or all phases of a specific separation problem, principle, or method. Manuscripts which have a high degree of novelty and fundamental significance to the field of separation science are particularly encouraged. It is expected the authors will clearly state in the Introduction how their method compares in some markedly new and improved way to previous published related methods. Analytical performance characteristics of new methods including sensitivity, tested limits of detection or quantification, accuracy, precision, and specificity should be provided. Manuscripts which describe a straightforward extension of a known analytical method or an application to a previously analyzed and/or uncomplicated sample matrix will not normally be reviewed favorably. Manuscripts in which mass spectrometry is the dominant analytical method and chromatography is of marked secondary importance may be declined.