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ANALYTICAL METHOD DEVELOPMENT AND VALIDATION OF REGADENOSON BY USING UV AND HPLC TECHNIQUE
Shubham D. Sapkal, Dr. Pankaj M. Pimpalshende, Dr. Satish B. Kosalge, Surbhi S. Rawka.
ABSTRACT
This study focuses on the development and validation of analytical methods for accurately quantifying Regadenoson in bulk drug samples. Two distinct approaches were explored: UV spectrophotometry and HPLC. Through meticulous optimization of chromatographic conditions, it was determined that a Buffer: ACN (40:60) mobile phase at pH 3 exhibited the highest efficacy for HPLC analysis. Conversely, UV spectrophotometric methods displayed no significant variance among proposed techniques, highlighting their applicability for routine and quality control analyses. Validation parameters encompassing linearity, precision, and robustness were thoroughly assessed, with the HPLC method showcasing notable precision, specificity, and accuracy. The resultant methods were characterized as straightforward, sensitive, precise, and accurate, thereby presenting Keywords: Regadenoson, HPLC, UV spectrophotometer, Precision, Specificity, Accuracy. [Download Article] [Download Certifiate] |