Development and Validation of HPTLC Method for Regadenoson and Its Pharmaceutical Formulation

Abstract

A new, simple, and rapid high-performance thin-layer chromatographic method was developed and validated for quantitative determination of Regadenoson. Regadenoson was chromatographed on silica gel 60 F254 TLC plate using ammonia:n-proapanol(3:7 v/v) as mobile phase. Regadenoson was quantified by densitometric analysis at 292nm. The method was found to give compact spots for the drug (Rf = 0.65). The linear regression analysis data for the calibration plots showed good linear relationship with R2 =0.999 in the concentration range 100–500 ng/spot. The accuracy and reliability of the proposed method was ascertained by evaluating various validation parameters like linearity, precision, accuracy, and specificity according to ICH guidelines. The proposed method provides a faster and cost effective quality control tool for routine analysis of Regadenoson as bulk drug and in injection formulation.