Abstract

ISOCRATIC RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR PHARMACEUTICAL TABLETS USING C18 COLUMN: A SYSTEMATIC REVIEW

K. Vijayalakshmi*, R. Naveen Kumar

Abstract

Reverse phase high-performance liquid chromatography (RPHPLC) is a popular analytical technique in pharmaceutical analysis for estimating drug concentrations in tablet dosage forms. The current review focuses on the development and validation of isocratic RP-HPLC techniques for analyzing pharmaceutical tablets utilizing C18 columns. In recent years, a great variety of analytical methods have been published for determining single and mixed drug formulations using simple and low-cost isocratic systems. The selection of an appropriate mobile phase composition, detection wavelength, flow rate, and column conditions is critical for obtaining accurate and exact results. The paper also discusses crucial validation criteria such as linearity, accuracy, precision, specificity, limit of detection (LOD), limit of quantification (LOQ), and robustness in accordance with ICH guidelines. This page summarizes many documented approaches for different drug types, such as analgesics, anti-diabetics, and cardiovascular medicines, in tablet dose forms. This review is valuable for researchers and postgraduate students who are developing analytical methods employing RP-HPLC. This study will be valuable for postgraduate students and researchers involved in pharmaceutical analysis, particularly in academic laboratories hat use isocratic RP- HPLC equipment with C18 columns for routine tablet analysis.

Keywords: RP-HPLC; Method Development; Method Validation; Isocratic HPLC; C18 Column; Pharmaceutical Tablets; Analytical Method; ICH Guidelines; Tablet Dosage Form; Pharmaceutical Analysis.