• GANGU SREELATHA

The gradient HPLC technique was developed in order to identify and estimate seven related substances in Regadenoson drug material. Also known as organic impurities, they come from what are known as By-products of the synthesis of drug substance. In the present work the optimized method chromatogram was run through the column ACE 3 C18- PFP, 150×4.6mm 3.0µm or equivalent and the diluent used was Dimethyl Sulfoxide, whereas buffer was 1.0 ml of methane Sulfonic acid in 1000ml of water. The flow rate used was 0.8ml/min and the detector wavelength were at 272nm. The temperature was maintained at 30ºC and injection volume was 5µl. The total run time was 55 minutes and the retention time for Regadenoson was found to be 17.1 min. The correlation coefficient obtained was 0.9995, while the LOD and LOQ values were found to be in the range of 3.3 to 4.8 and 10.7 to 14.1 respectively. %RSD was found to be well within the limits.

Regadenoson, Methane Sulfonic Acid, Dimethyl Sulfoxide, Related Substances, RSD, LOD, LOQ.

"A REVIEW ON DETECTION AND EVALUATION OF IMPURITIES IN REGADENOSON MONOHYDRATE DRUG MATERIAL BY RP-HPLC – A STABILITY STUDY", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 2, page no.g455-g458, February-2024, Available :http://www.jetir.org/papers/JETIR2402659.pdf

"A REVIEW ON DETECTION AND EVALUATION OF IMPURITIES IN REGADENOSON MONOHYDRATE DRUG MATERIAL BY RP-HPLC – A STABILITY STUDY", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 2, page no. ppg455-g458, February-2024, Available at : http://www.jetir.org/papers/JETIR2402659.pdf