A QbD Based RP-HPLC Method for Stability Indicating Impurity Profiling of Pyridoxine: Method Development, Validation, and Application

Q3 Pharmacology, Toxicology and Pharmaceutics

International Journal of Pharmaceutical Quality Assurance Pub Date : 2023-09-25 DOI:10.25258/ijpqa.14.3.40

Avinash Chavan, R Gandhimathi

引用次数: 0

Abstract

Pyridoxine impurity profiling in bulk and formulations was devised and validated using a reversed-phase high-performance liquid chromatography (RP-HPLC) strategy. The technique was fine-tuned using an Analytical quality by design (QbD) approach, ensuring its dependability and sturdiness. Linearity, accuracy, and precision were carefully examined as key performance indicators. With a relative standard deviation (RSD) < 2%, the approach showed exceptional precision, excellent recovery rates (100 and, 101.2%), and a strong correlation value (R2 = 0.9990). The technique has been used successfully for impurity profiling, and because it indicates stability, it can be used for long-term stability studies. The work contributes to the body of knowledge and has applications for pharmaceutical quality assurance.

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基于QbD的反相高效液相色谱法测定吡哆醇杂质的稳定性:方法开发、验证和应用

采用反相高效液相色谱(RP-HPLC)策略设计并验证了吡哆醇原料药和制剂的杂质分析。该技术采用分析质量设计(QbD)方法进行微调，确保其可靠性和稳定性。线性度、准确度和精密度作为关键性能指标进行了仔细的检查。具有相对标准偏差(RSD) <结果表明，该方法精密度高，回收率分别为100和101.2%，相关性强(R2 = 0.9990)。该技术已成功地用于杂质分析，因为它表明稳定性，它可以用于长期稳定性研究。这项工作为知识体系做出了贡献，并在药品质量保证方面有应用。

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

International Journal of Pharmaceutical Quality Assurance Pharmacology, Toxicology and Pharmaceutics-Pharmacology, Toxicology and Pharmaceutics (miscellaneous)

CiteScore

0.80

自引率

0.00%

发文量

期刊介绍： INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE is a quarterly international journal publishing the finest peer-reviewed research in the field of Pharmaceutical Quality Assurance and Pharmaceutical Analysis on the basis of its originality, importance, disciplinary interest, timeliness, accessibility, elegance, and surprising conclusions. IJPQA also provides rapid, authoritative, insightful and arresting news and interpretation of topical and coming trends affecting science, scientists and the wider public.