ANALYTICAL VALIDATION OF STABILITY-INDICATING METHOD FOR ESTIMATION OF ANTIHYPERTENSIVE DRUGS USING REVERSE PHASE ULTRA-PERFORMANCE LIQUID CHROMATOGRAPHY: A REVIEW

Antihypertensive drugs are widely used for the long-term management of elevated blood pressure and associated cardiovascular complications. Reliable analytical procedures are essential for confirming the identity, strength, purity, quality, and stability of these pharmaceutical substances and formulations. Reverse phase ultra-performance liquid chromatography (RP-UPLC) has emerged as an efficient chromatographic technique for pharmaceutical analysis because of its high separation efficiency, rapid analysis, improved resolution, reduced solvent consumption, and compatibility with different detection systems. A stability-indicating analytical method is particularly important because it should distinguish the intact drug from degradation products, process-related impurities, and formulation components. The present review discusses the principles of RP-UPLC, analytical method development, forced degradation studies, and validation of stability-indicating methods for antihypertensive drugs. Important validation characteristics, including specificity, linearity, accuracy, precision, detection limit, quantitation limit, robustness, and system suitability, are discussed in relation to current analytical practice. The role of analytical quality by design (AQbD), risk assessment, design of experiments, and method lifecycle management is also considered. Overall, a properly developed and validated RP-UPLC method can provide a rapid, sensitive, reproducible, and stability-indicating approach for pharmaceutical quality control and stability assessment of antihypertensive drug products.