DEVELOPMENT AND VALIDATION OF STABILITY-INDICATING RP-UPLC METHODS FOR DETERMINATION OF DRUGS IN PHARMACEUTICAL DOSAGE FORMS: A COMPREHENSIVE REVIEW
J. Pavan Kumar*, Rajiv Kukkar
ABSTRACT
Stability-indicating analytical methods are essential for assessing the quality, safety, and stability of
pharmaceutical products throughout their lifecycle. Reverse-phase ultra-performance liquid chromatography (RPUPLC)
has emerged as an efficient analytical technique because of its high chromatographic efficiency, rapid
separation, improved resolution, and reduced solvent consumption. The development of a stability-indicating
method requires appropriate forced degradation studies, effective separation of the drug from degradation
products, and comprehensive validation. In recent years, Analytical Quality by Design (AQbD) has transformed
analytical method development from empirical trial-and-error experimentation toward a systematic, science- and
risk-based approach. AQbD incorporates the Analytical Target Profile (ATP), risk assessment, Critical Method
Parameters (CMPs), Design of Experiments (DoE), statistical modelling, and establishment of a Method Operable
Design Region (MODR) (Xuan et al., 2024). This review discusses the principles and applications of stabilityindicating
RP-UPLC methods, forced degradation studies, chromatographic optimization, AQbD implementation,
statistical experimental design, analytical validation, and regulatory expectations under ICH Q2(R2) and Q14.
Keywords: RP-UPLC, stability-indicating method, forced degradation, AQbD, Design of Experiments, method validation, pharmaceutical analysis, ICH Q14, ICH Q2(R2), degradation products.
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