Abstract

EXPLORING MODERN RP-HPLC TECHNIQUES FOR ACCURATE ESTIMATION AND VALIDATION IN DIFFERENT DOSAGE FORMS

Muskan Pal*, Ritunja Singh and Dr. Arpita Singh

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Abstract

In this review attempts to highlight the recent innovations in Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) with special reference to its use in the estimation and validation of various pharmaceutical dosage forms including tablets, capsules, liquid formulations, and injectables. With drug delivery systems and combination products becoming more and more advanced, there also arises a need for advanced analytical methods to cope with complicated formulations while keeping up with demanding regulatory requirements. It has emerged as a core tool within pharmaceutical analysis owing to its extremely high sensitivity, accuracy, and versatility in the determination of active pharmaceutical ingredients (APIs) and impurities. This paper discusses recent trends and recent technological advances in RP-HPLC, including mobile phase composition innovations, column choice, detector innovations, and gradient elution approaches that lead to enhanced method efficiency and shorter analysis time. The core elements of method development and validation like linearity, accuracy, precision, specificity, limit of detection (LOD), and limit of quantification (LOQ) are comprehensively reviewed to highlight their importance in guaranteeing the reliability of data as well as conformity to regulations. The review also discusses the application of Quality by Design (QbD) principles, illustrating how risk assessment and design of experiments (DoE) facilitate the development of robust, reproducible analytical procedures. Regulatory guidelines such as ICH, USP, and FDA standards are regarded to harmonize analytical methodologies with industrial standards. In conclusion, the present review presents an extensive overview of contemporary RP-HPLC methods and their pivotal significance in pharmaceutical quality control, facilitating further development of drug discovery and validation protocols.

Keywords: RP-HPLC, AI-driven optimization, green chromatography, QbD, LC-MS, PAT, ICH, USP, and FDA.