::INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES::

CODEN : IAJPBB
issn 2349-7750

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TITLE:

METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN BULK AND PHARMACEUTICAL DOSAGE FORM BY UV-SPECTROSCOPIC METHOD

AUTHORS:

V.Shirisha*, K.Sarika Reddy, SK.Akbar, J.Vamshi, K.Archana , Santhosh Illendula, K.N.V.Rao, K. Rajeswar Dutt.

ABSTRACT:

A simple, sensitive, highly accurate spectrophotometric method has been developed for the determination of Dapagliflozin in bulk and pharmaceutical tablet dosage form as per ICH Guidelines. The adequate drug solubility and maximum assay sensitivity was found in sodium citrate. The absorbance of Dapagliflozin was measured at 231 nm in the wavelength range of 200‐400 nm. Beer’s law was obeyed in the concentration range of 10-50 μg/mL, in the linearity study regression equation was found to be y =0.2125x+0.0085 & amp; correlation coefficient was found to be 0.999. This method was Rugged and Robust in different testing criteria, LOD and LOQ was found to be 2.19μg / ml & 6.641 μg / ml respectively. Accuracy study was done in 3 different concentration levels 50, 100, 150% & % recovery of the method was found to be 99.8%, 99.7%, 99.8% respectively in 3 different levels & mean recovery was 99.7%, so method was accurate. Results of all validation parameter were within the limit as per ICH guideline. Results of percentage recovery shows that the method was not affected by the presence of common excipients. The proposed method has been successfully used for the analysis of the drug in pure and its tablet dosage forms. easily and the method was precise accurate to perform in future Keywords: Dapagliflozin, UV Visible Spectrophotometry, Method development, Validation, ICH guidelines, Sodium citrate , Accuracy, Precision.