International Journal For Multidisciplinary Research

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ANALYTICAL METHOD VALIDATION FOR ANTI-TUBERCULOSIS DRUGS: A REVIEW OF RIFAMPICIN ISONIAZID AND PYRIDOXINE

Author(s) Ms. Himanshi Aggarwal, Dr. Kalpana Singh
Country India
Abstract TB is still a major worldwide health concern, especially in low- and middle-income nations. Accurate dosing, pharmacokinetic profile, and quality control of vital medications including pyridoxine, isoniazid, and rifampicin are crucial to the effectiveness of anti-tuberculosis treatment. For methods used for drug quantification in bulk materials, pharmaceutical formulations, and biological matrices to be reliable, specific, and reproducible, analytical method validation is essential. This study offers a thorough summary of the approved analytical techniques used to determine pyridoxine, isoniazid, and rifampicin, namely High-Performance Liquid Chromatography (HPLC), UV-Visible spectrophotometry, and LC-MS/MS. In compliance with ICH and USP criteria, important validation factors are examined, including accuracy, precision, linearity, sensitivity, specificity, robustness, and system adaptability. Rifampicin needs method development techniques that address matrix interference and degradation because of its instability and low solubility. While pyridoxine, which is used prophylactically to avoid neurotoxicity from isoniazid, requires precise monitoring, particularly in fixed-dose combination therapy, isoniazid, a hydrophilic molecule, presents difficulties in derivatization and UV detection. Common problems include matrix effects in biological materials and drug-drug interactions during co-formulation are also highlighted in the paper. Additionally assessed are recent developments in chromatographic methods, such as UPLC and bioanalytical validations for monitoring therapeutic drugs (TDM). In order to promote strong quality assurance and regulatory compliance in anti-TB pharmacotherapy and enhance treatment results and medication safety, this paper attempts to compile important insights into method development and validation.
Keywords Tuberculosis, TB, Rifampicin, Isoniazid, Pyridoxine, and Analytical Method Validation.
Field Medical / Pharmacy
Published In Volume 7, Issue 3, May-June 2025
Published On 2025-06-19
DOI https://doi.org/10.36948/ijfmr.2025.v07i03.46700
Short DOI https://doi.org/g9qxcv
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