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

Reverse phase high-performance liquid chromatography (RP-HPLC) 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.

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2026-04-16
DOI
https://doi.org/10.5281/zenodo.19629001
Primary Topic
Analytical Methods in Pharmaceuticals
Type
article
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article

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

R. Naveen Kumar2 K. Vijayalakshmi1*
Zenodo (CERN European Organization for Nuclear Research)
Analytical Methods in Pharmaceuticals
article

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

R. Naveen Kumar2 K. Vijayalakshmi1*
article en

Abstract

Reverse phase high-performance liquid chromatography (RP-HPLC) 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.

Zenodo (CERN European Organization for Nuclear Research)
Openalex Percentile: Top 7%
Analytical Methods in Pharmaceuticals
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