A Review on Analysis of Dapagliflozin.

Abstract

Dapagliflozin is a sodium-glucose co transporter 2 inhibitor (SGLT2) as a new class of oral antidiabetic drugs. It is indicated for treatment of Diabetes mellitus type 2, either alone or in combination with other oral hypoglycaemic agents. The aim of this review is to focus on update of determination of Dapagliflozin in bulk and in pharmaceutical preparations using chromatographic and spectrophotometric methods. Dapagliflozin is estimated by RP-HPLC, UV, RP-UPLC, LC-MS methods. This review provides detailed information on separation conditions for Dapagliflozin alone, in the presence combination with other drugs and in presence of its degradation products. KEYWORDS Dapagliflozin, RP-HPLC, UV, RP-UPLC, LC-MS/MS. mobile phase with the flow rate of 1 ml/min (milliliter/minute). The effluent was detected at 222 nm (nanometer) using photo diode array detector. The retention time of Dapagliflozin API and Dapagliflozin tablet were 3.160 min (minute) and 3.067 min (minute) respectively. Linearity for Dapagliflozin was established in the range of 50-150µg/ml (microgram/milliliter) (R2 = 0.99) respectively. The % recoveries of Dapagliflozin API and tablet were found to be in the range of 99.00-99.99 % and 98.50-99.99 % respectively. Precision studies were carried out and the relative standard deviation values were less than two. LOD and LOQ were noted to be 5.14 µg/ml and 15.6 µg/ml for API. The method was found to be robust. The proposed method was found to be specific, accurate, precise and robust can be used for estimation of Dapagliflozin in API and Pharmaceutical dosage form. Subrata Sarkar et al. [5] developed and validated a new simple, rapid, efficient and reproducible reverse phase high performance liquid chromatographic (RP-HPLC) method for the estimation of Dapagliflozin in Tablet dosage form. The separation was carried on a Symmetry C18, 25cmx 4.6mm i.d. 5μm, Particle size column. Mobile phase was mixture of Methanol: ACN: % OPA in a ratio of 75:25:05 v/v/v at a flow rate of 1.0ml/min. Dapagliflozin shows maximum absorbance at 246nm. Dapagliflozin was resolved at 2.797minutes. The Dapagliflozin drug was linear in the concentration range of 0-70μg/ml and correlation coefficient was 0.99. LOD & (LOQ) were found to be 0.04 & 0.12 μg/ml respectively. The developed method is also found to be simple, precise, accurate, specific, robust and rapid for the estimation of Dapagliflozin in bulk and tablet dosage form. Manasa Sangapati et al. [6] reported an accurate, precise, specific and rapid RP-HPLC method for the determination of Dapagliflozin in API. The method was developed and validated as described in ICH guidelines. Better separation of the drug was performed by BDS column (250×4.5mm, 5μ). Mixture of ortho phosphoric acid and acetonitrile (45:55 v/v) as a mobile phase at a flow rate of 1ml/min. Eluent was monitored using PDA detector at 245nm. The developed method was validated for different parameters such as linearity, accuracy, precision, limit of detection (LOD), limit of Quantitation (LOQ), robustness. The re...