Development Of Validated Hptlc Method for Determination of Eletriptan Hydrobromide as Bulk Drug and In Tablet Dosage Form

Abstract

The aim of the present study was to develop a highly precise and accurate HPTLC method for the estimation of eletriptan hydrobromide in pharmaceutical formulations. The method was systematically validated according to International Council for Harmonisation (ICH) guidelines, and various validation parameters, including accuracy, precision, limit of detection (LOD), limit of quantification (LOQ), recovery studies, and linearity range, were thoroughly evaluated. The developed HPTLC method demonstrated simplicity, rapid execution, robustness, and high precision, making it suitable for routine quality control analysis of eletriptan hydrobromide in both bulk drug and pharmaceutical combinations. The method exhibited excellent linearity in the concentration range of 100–500 µg/mL, with a correlation coefficient (r²) of 0.995, indicating a strong linear relationship between peak area and drug concentration. Accuracy studies showed satisfactory percent recoveries, confirming the method’s reliability. Precision was demonstrated through repeatability and intermediate precision studies, with low relative standard deviation values. The LOD and LOQ were found to be within acceptable limits, signifying the method’s sensitivity for detecting and quantifying low levels of the drug. Recovery studies further confirmed the absence of interference from excipients present in the pharmaceutical formulations. Overall, the proposed HPTLC method is simple, fast, cost-effective, and highly reliable. It can be successfully applied for the routine analysis and quality assessment of eletriptan hydrobromide in various dosage forms, ensuring the drug’s consistency, stability, and compliance with regulatory standards over its shelf life.