Development and Validation of RP-HPLC method for the determination of Pyridostigmine drug

Abstract

A reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative determination of Pyridostigmine, a drug commonly used in the treatment of myasthenia gravis, both in bulk drug and tablet formulations. The method offers high precision, accuracy, and sensitivity, making it suitable for routine quality control analysis. This study outlines the optimization of chromatographic conditions, method validation, and results that comply with ICH guidelines, including specificity, linearity, precision, accuracy, and robustness. This research article focuses on the RP-HPLC method development and validation for Pyridostigmine, ensuring it is fit for use in pharmaceutical applications such as routine[1-4] quality control and analysis. RP-HPLC method development and validation are crucial in the pharmaceutical industry for ensuring the quality, safety, and efficacy of drug products. Pyridostigmine, a drug commonly used to treat myasthenia gravis, requires robust and reliable analytical methods for its quantification and quality control. RP-HPLC (Reversed-Phase High-Performance Liquid Chromatography) is a widely used technique for this purpose due to its versatility, sensitivity, and ability to separate complex mixtures.[4-5]

Keywords: Pyridostigmine, RP-HPLC, Method Development, Validation, Bulk Drug, Tablets, Myasthenia Gravis, Pharmaceutical Analysis