ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF ROPIVACAINE: A REVIEW OF UV AND HPLC TECHNIQUES
Gunasekaran A.*, T. Vetrichelvan Thangarasu, S. Murugan
ABSTRACT
Ropivacaine hydrochloride is a widely used long-acting local anesthetic that requires reliable analytical methods to ensure its quality, safety, and therapeutic efficacy. Numerous analytical techniques have been reported for its quantitative determination, among which UV spectrophotometry and reverse-phase high-performance liquid chromatography (RP-HPLC) are the most commonly employed. Previous reported methods for stability-indicating forced degradation studies was not performed. Therefore, a new stability indicating RP-HPLC method was going to develop and validate. The new stability indicating RP-HPLC method is accurate, precise, reliable, and suitable for routine analysis and stability studies of Ropivacaine Hydrochloride in pharmaceutical formulations. There is No UV spectroscopy method was not done in literature review. So I plan to do UV spectroscopy method by using simple solvent in e.g Distilled water. The reported methods were compared based on chromatographic conditions, sensitivity, specificity, precision, accuracy, and compliance with ICH validation requirements. The review demonstrates that UV spectrophotometric methods are suitable for rapid routine analysis, whereas RP-HPLC offers superior performance for stability studies, impurity profiling, and regulatory quality control. overall, this review provides a comprehensive evaluation of the reported analytical methods for ropivacaine hydrochloride and serves as a valuable reference for method selection, validation, pharmaceutical development, and quality control.
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