Stability-Indicating RP-HPLC Method Development and Validation for Quantification of Butylated Hydroxyanisole Content in Loperamide Oral Solid Dosage Form

IF 1.8 4区医学 Q4 BIOCHEMICAL RESEARCH METHODS

Biomedical Chromatography Pub Date : 2025-05-26 DOI:10.1002/bmc.70103

Prasanna Kumar Lankalapalli, Srinivasulu Kasa, Pranitha Sambu, Rama Krishna Myneni, Teja Kamireddy, Vijaykumar chollety, Hareesh Divadari

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Abstract

The present study discusses the development of a simple, rapid, and specific high-performance liquid chromatography (HPLC) method for the estimation of butylated hydroxyanisole (BHA) in loperamide HCl capsule dosage formulations. The developed HPLC method was validated in accordance with current ICH guidelines. Chromatographic separation was achieved using a phosphate buffer (pH 6.8) as mobile phase A and a mixture of acetonitrile and buffer in a ratio of 80:20 (v/v) as mobile phase B. The flow rate was 0.8 mL/min, and column temperature was maintained at 35°C. Detection of the component was performed at 290 nm for BHA. The optimized HPLC method was validated as per current ICH guidelines and demonstrated high specificity with a linearity range of 13–83 μg/mL for BHA, with a correlation coefficient greater than 0.999. The method showed accuracy exceeding 97%. Stress studies revealed that BHA is sensitive to peroxide stress conditions. The results highlight the successful applicability of the current method for estimating BHA in marketed formulations, which can be further utilized to evaluate other formulation systems. The developed method was validated according to international ICH guidelines concerning specificity, linearity, precision, and accuracy. The method was developed and validated in a quality control lab for stability analysis.

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稳定性指示反相高效液相色谱法测定洛哌丁胺口服固体剂型中丁基羟基茴香醚含量的建立与验证

本研究探讨了一种简便、快速、特异的高效液相色谱法测定盐酸洛哌丁胺胶囊剂型中丁基羟基茴香醚（BHA）含量的方法。根据现行的ICH指南对该方法进行了验证。以磷酸缓冲液（pH 6.8）为流动相a，乙腈与缓冲液的混合物以80:20 （v/v）的比例为流动相b进行色谱分离，流速0.8 mL/min，柱温35℃。在290 nm处对BHA进行成分检测。优化后的高效液相色谱法符合现行ICH指南，对BHA的特异性较高，线性范围为13 ~ 83 μg/mL，相关系数大于0.999。该方法准确度超过97%。胁迫研究表明，BHA对过氧化胁迫条件很敏感。研究结果表明，目前的方法在市场配方中评估BHA是成功的，可以进一步用于评估其他配方体系。根据国际ICH指南对所开发的方法进行了特异性、线性度、精密度和准确性的验证。该方法在质量控制实验室进行了稳定性分析和验证。

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来源期刊

Biomedical Chromatography 生物-分析化学

CiteScore

3.60

自引率

5.60%

发文量

268

审稿时长

2.3 months

期刊介绍： Biomedical Chromatography is devoted to the publication of original papers on the applications of chromatography and allied techniques in the biological and medical sciences. Research papers and review articles cover the methods and techniques relevant to the separation, identification and determination of substances in biochemistry, biotechnology, molecular biology, cell biology, clinical chemistry, pharmacology and related disciplines. These include the analysis of body fluids, cells and tissues, purification of biologically important compounds, pharmaco-kinetics and sequencing methods using HPLC, GC, HPLC-MS, TLC, paper chromatography, affinity chromatography, gel filtration, electrophoresis and related techniques.