Development and Validation of Stability Indicating Implementation of Quality by Design (QbD) Approach RP-HPLC Method for Quantitative Estimation of Metaxalone in Tablet Dosage Form

International Journal of Applied Chemistry

© 2020 by SSRG - IJAC Journal

Volume 7 Issue 3

Year of Publication : 2020

Authors : N. Prasad Babu, Dr. D. Ramachandran

10.14445/23939133/IJAC-V7I3P103

How to Cite?

N. Prasad Babu, Dr. D. Ramachandran, "Development and Validation of Stability Indicating Implementation of Quality by Design (QbD) Approach RP-HPLC Method for Quantitative Estimation of Metaxalone in Tablet Dosage Form," SSRG International Journal of Applied Chemistry, vol. 7,  no. 3, pp. 9-20, 2020. Crossref, https://doi.org/10.14445/23939133/IJAC-V7I3P103

Abstract:

A new, simple, rapid, selective, precise, and accurate isocratic reverse-phase high-performance liquid Chromatography assay method has been developed to estimate Metaxalone in tablet formulations. The separation was achieved using column Zorbax SB-AQ (150x4.6mm, 3.5μ) in the mobile phase consisting of pH 2.5 phosphate buffer and Acetonitrile. The flow rate was 1.5 mL/min, column oven temperature and sampler cooler was maintained 25°C, respectively. The Metaxalone was detected using a U.V. detector at the wavelength of 220 nm, and the injection volume was 10μL. Metaxalone's retention time was noted to be 4.40 min, respectively, indicative of rather shorter analysis time. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.

Keywords:

Metaxalone, Liquid chromatography, Force Degradation, QbD, and Validation.

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