Development and Validation of a New Reversed Phase HPLC Method for the Quantitation of Azithromycin and Rifampicin in a Capsule Formulation.

IF 1.5 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS

Journal of chromatographic science Pub Date : 2024-10-01 DOI:10.1093/chromsci/bmae006

Foram Patel, Rajendra Kotadiya, Rashmin Patel, Mrunali Patel

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引用次数: 0

Abstract

This research aimed to develop a new method for simultaneously estimating the presence of azithromycin (AZT) and rifampicin (RIF) in a capsule formulation using reverse-phase high-performance liquid chromatography. The developed method utilized a Gemini column with a 60:40% v/v acetonitrile and potassium dihydrogen phosphate mobile phase, a flow rate of 1 mL/min, and an injection volume of 20 μL. The detection wavelengths of 210 and 254 nm for AZT and RIF, respectively, were used. Validation ensures specificity with a peak purity index > 0.99999 for AZT and >0.99995 for RIF, affirming unambiguous analyte detection. The system suitability test, within acceptable limits, validates method reliability. Linearity calibration curves (R2 = 0.998) cover a 25-150% target concentration range. Accuracy studies employing the standard addition method yield recovery values between 96.6 and 103.9% for both drugs, confirming method accuracy. Precision studies reveal % relative standard deviation values consistently below 2%, highlighting reproducibility. Robustness testing supports method reliability under varying conditions. Application to a pharmaceutical capsule formulation demonstrates the method's practicality, accurately quantifying AZT (98.30%) and RIF (99.37%). This study provides a validated analytical approach for simultaneous quantification in commercial pharmaceutical products containing both drugs, enhancing pharmaceutical quality control for critical antibiotics in complex formulations.

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用于胶囊制剂中阿奇霉素和利福平定量的新型反相高效液相色谱法的开发与验证

本研究旨在开发一种新方法，利用反相高效液相色谱法同时估测胶囊制剂中阿奇霉素（AZT）和利福平（RIF）的含量。该方法采用 Gemini 色谱柱，流动相为 60:40% v/v 乙腈和磷酸二氢钾，流速为 1 mL/min，进样量为 20 μL。AZT 和 RIF 的检测波长分别为 210 纳米和 254 纳米。验证确保了特异性，AZT 的峰纯度指数大于 0.99999，RIF 的峰纯度指数大于 0.99995，肯定了分析物检测的明确性。在可接受范围内进行的系统适用性测试验证了方法的可靠性。线性校准曲线（R2 = 0.998）覆盖 25-150% 的目标浓度范围。采用标准添加法进行的准确度研究表明，两种药物的回收率介于 96.6% 和 103.9% 之间，证实了方法的准确性。精密度研究显示，相对标准偏差的百分比值始终低于 2%，突出了重现性。稳健性测试证明了该方法在不同条件下的可靠性。在药物胶囊制剂中的应用证明了该方法的实用性，可准确定量 AZT（98.30%）和 RIF（99.37%）。这项研究为同时定量含有这两种药物的商业药品提供了一种经过验证的分析方法，从而加强了对复杂制剂中关键抗生素的药品质量控制。

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.