Volume : 13, Issue : 05, May – 2026
Title:
A COMPREHENSIVE REVIEW OF RP-HPLC TECHNIQUES FOR IMPURITY PROFILING IN PHARMACEUTICAL DRUG ANALYSIS
Authors :
Ms. Kadam Susmita Bhausaheb*, Ms. Waghmode P.A., Mr. A.B. Waghmode,Dr. Nagaraju Potnuri
Abstract :
Impurity profiling is an essential component of pharmaceutical analysis that ensures the safety, efficacy, stability, and quality of drug substances and pharmaceutical formulations. The presence of impurities in active pharmaceutical ingredients (APIs) and finished dosage forms may arise from synthesis, degradation, storage conditions, residual solvents, excipient interactions, or manufacturing processes. Regulatory agencies such as ICH, USFDA, USP, BP, and IP have established stringent guidelines for identification, quantification, qualification, and control of impurities in pharmaceutical products. Among various analytical techniques, reversed-phase high-performance liquid chromatography (RP-HPLC) has emerged as one of the most reliable, sensitive, and widely employed methods for impurity profiling due to its excellent resolution, reproducibility, specificity, and compatibility with different detection systems. The present review comprehensively discusses the concept, classification, sources, and regulatory aspects of pharmaceutical impurities along with detailed applications of RP-HPLC in impurity profiling. The review also highlights RP-HPLC method development strategies, forced degradation studies, stability-indicating methods, and advanced detection approaches used for impurity analysis. Various chromatographic parameters including column selection, mobile phase optimization, buffer selection, pH optimization, wavelength selection, and gradient elution techniques have also been discussed. Furthermore, the applications of RP-HPLC in API impurity profiling, degradation product analysis, residual solvent analysis, genotoxic impurity determination, herbal drug analysis, and biological sample analysis are summarized. Owing to its high sensitivity, versatility, and regulatory acceptance, RP-HPLC continues to play a central role in pharmaceutical quality control and impurity assessment. The review concludes that RP-HPLC remains an indispensable analytical tool for comprehensive impurity profiling and stability evaluation in modern pharmaceutical industries.
KEYWORDS:RP-HPLC; Impurity Profiling; Pharmaceutical Analysis; Degradation Products; Stability-Indicating Method; ICH Guidelines; Genotoxic Impurities; Residual Solvents.
Cite This Article:
Please cite this article in press Kadam Susmita Bhausaheb et al., A Comprehensive Review Of Rp-Hplc Techniques For Impurity Profiling In Pharmaceutical Drug Analysis., Indo Am. J. P. Sci, 2026; 13(05).,
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