A SENSITIVE AND ECONOMICAL DIFFERENT SPECTROSCOPIC METHODS DEVELOPMENT AND VALIDATION FOR THE QUANTIFICATION OF CAPECITABINE AND STRESS DEGRADATION STUDIES

KALLAM JEEVAN SAI; SUMANTA MONDAL; SUBHADIP CHAKRABORTY; BABY NALANDA REVU

doi:10.22159/ijap.2023v15i3.47316

Authors

KALLAM JEEVAN SAI Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam 530045, A.P., India https://orcid.org/0009-0006-8964-5711
SUMANTA MONDAL Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam 530045, A.P., India
SUBHADIP CHAKRABORTY Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam 530045, A.P., India https://orcid.org/0000-0003-4232-4022
BABY NALANDA REVU Department of Pharmaceutical Chemistry, School of Pharmacy, GITAM (Deemed to be University), Gandhinagar Campus, Rushikonda, Visakhapatnam 530045, A.P., India https://orcid.org/0000-0002-9314-2459

DOI:

https://doi.org/10.22159/ijap.2023v15i3.47316

Keywords:

Capecitabine, Spectroscopic methods, Method development, Validation, Stress degradation studies.

Abstract

Objective: The present investigation aims to develop an efficient, rapid, sensitive, selective, linear, and accurate method for analyzing capecitabine in bulk and tablet dosage form by UV-spectroscopy approaches.

Methods: Capecitabine is an estimation by three different developed methods with different UV detection, method A (zero-order spectrophotometric method) at 239 nm, method B (first-order spectrophotometric method) at 231 nm, and method C (area under the curve spectrophotometric method) at 230 to 248 nm. The method's validation and stress degradation studies were done following the International Conference on Harmonization (ICH) guidelines.

Results: The methods were validated using the prescribed parameters like system suitability, LOD, LOQ, accuracy, precision, robustness, specificity, etc. The relative standard deviation (% RSD) of the peak area observed in each case was found within the accepted range (<2%). The linearity study's coefficient of correlation (R²) value was <0.99. The drug was found to be quantified accurately in the presence of its degraded products.

Conclusion: The developed simple and economical method is a suitable option for the qualitative and quantitative study of capecitabine in bulk and tablets, even in its degraded products, which may arise because of oxidation, hydrolysis, thermal, and photolytic decomposition.

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