Abstract

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 presentingviable options for routine Regadenoson analysis in pharmaceutical formulations. While these methods don't supplant existing ones, they offer alternative avenues for routine analysis. Furthermore, prospective research directions were identified, including stress degradation studies for identifying drug degradation products, the advancement of more sensitive methodologies like HPLC-MS or tandem MS, and the amalgamation of techniques such as LC-MS-MS and LC-NMR for enhanced molecular weight determination and structural elucidation. Additionally, the adoption of microbore columns and UPLC techniques holds promise for augmenting sensitivity, expediting analyses, and refining accuracy in analytical methodologies.

Keywords: Regadenoson, HPLC, UV spectrophotometer, Precision, Specificity, Accuracy.