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VOL. 10, ISSUE 1 (2026)
Development and validation of stability-indicating chromatographic methods for single and multi-component pharmaceutical dosage forms
Authors
Hareesh Kasam, Dr. Harbeer Singh
Abstract
The development and
validation of stability-indicating chromatographic methods for single and
multi-component pharmaceutical dosage forms is crucial to ensure accurate
quantification of active pharmaceutical ingredients (APIs) in the presence of
degradation products, impurities, and excipients. This study aimed to establish
validated analytical procedures capable of assessing drug stability and quality
throughout a product's lifecycle. A reverse-phase high-performance liquid
chromatography (RP-HPLC) method was optimized using a C18 column and gradient
elution with a mobile phase consisting of an aqueous buffer (pH 3.0) and
acetonitrile. Forced degradation studies were conducted under hydrolytic,
oxidative, thermal, and photolytic stress conditions as per ICH Q1A(R2)
guidelines. The method demonstrated excellent peak resolution, specificity, and
sensitivity, allowing clear separation of APIs from their degradation products.
Validation was performed according to ICH Q2(R1), and all parameters, including
linearity, precision, accuracy, LOD, LOQ, and robustness, met acceptance
criteria. The method was successfully applied to both single and
multi-component dosage forms, demonstrating its versatility and applicability
in pharmaceutical analysis. Compared to previously reported methods, the
developed procedure offers improved resolution, shorter run times, and strong stability-indicating
capability. The validated stability-indicating chromatographic method fulfills
the essential criteria for reliable use in routine quality control, formulation
development, impurity monitoring, and regulatory submissions.
Pages:47-50
How to cite this article:
Hareesh Kasam, Dr. Harbeer Singh "Development and validation of stability-indicating chromatographic methods for single and multi-component pharmaceutical dosage forms". International Journal of Chemistry Studies, Vol 10, Issue 1, 2026, Pages 47-50
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