Development and Validation of Stability-Indicating RP-HPLC Methods for Pharmaceutical Drugs: A Comprehensive Review

One important feature of pharmaceutical goods that has a direct bearing on their safety, effectiveness, and shelf life is stability. The need for reliable, validated analytical techniques grows as regulatory requirements change and formulation complexity rises. Because of its excellent resolution, sensitivity, reproducibility, and adaptability, Reverse Phase Excellent-Performance Liquid Chromatography (RP-HPLC) has become the gold standard among analytical techniques for creating stability-indicating methods (SIMs). The principles, development techniques, and validation criteria for stability-indicating RP-HPLC methods in the pharmaceutical business are thoroughly examined in this review article. A thorough review of method development, including the choice of chromatographic conditions, mobile and stationary phases, and detection parameters, follows a discussion of the significance of SIMs in guaranteeing medication quality. According to ICH Q1A(R2) recommendations, forced degradation tests are crucial for assessing the method's capacity to differentiate between the active pharmaceutical ingredient (API) and its breakdown products. The article also describes the validation procedure in accordance with ICH Q2(R1), emphasizing important criteria including robustness, specificity, linearity, accuracy, precision, limit of detection (LOD), and limit of quantification (LOQ). It is also covered how to include contemporary quality paradigms like Design of Experiments (DoE) and Quality by Design (QbD) into method development, highlighting how they can improve method robustness and regulatory compliance. Overall, this review contributes to efficient quality control, regulatory approval, and safe therapeutic outcomes by highlighting the crucial role stability-indicating RP-HPLC methods play in pharmaceutical analysis and offering a scientific framework for their methodical development and validation. Method dependability and regulatory compliance are improved by incorporating contemporary methods like Design of Experiments (DoE) and Quality by Design (QbD). All things considered, RP-HPLC is still an essential tool for pharmaceutical stability testing and quality control.