Dapagliflozin is a highly selective, orally active and reversible inhibitor of the human sodium glucose cotransporter 2 (SGLT2). The dapagliflozin is a diabetic drug which is used with proper diet and exercise in adults with type 2 diabetes to improve the glycemic control. The aim of this study is to develop a rapid, precise and accurate RP-HPLC method for estimation of dapagliflozin in bulk and formulation as per ICH guidelines. The chromatography was carried on Sunsil C18 (150 X4.5mm, 5µ) column HPLC (Water's) using a mixture of methanol and water at different ratios and finally optimized with 85:15 v/v as mobile phase with flow rate 1.0ml/min at 225nm. The correlation regression is found to be 0.999. The retention time was found to be 2.74min. The accuracy of the present method was evaluated at 50%, 100% and 150%. The recoveries of dapagliflozin API and tablet were found to be in the range of 98.5%-100.6%. Precision studies were carried out and the relative standard deviation values were less than two. The method was found to be robust. The limit of detection and limit of quantification were determined as 0.011µg/ml and 0.034µg/ml. The proposed method was found to be rapid, precise, accurate and robust and can be used for the estimation of dapagliflozin in API and Pharmaceutical dosage form.
To develop an accurate, precise, specific high performance liquid chromatography method for quantification of Canagliflozin in bulk and dosage forms. A C18 column (250mm X 4.6mm; 5μm phenomenex) was used with mobile phase containing Acetonitrile-0.1% sodium acetate buffer (pH-4.6), (20:80) in isocratic mode. The flow rate maintained was 1.0ml/min and the U.V detector was operated at 291nm. The retention time of Canagliflozin was 3.307min and showed a good linearity in concentration range of 2-14μg/ml with correlation coefficient of 0.999. The average percent recovery was found to be 99.98%. The developed method follows validation parameters such as system suitability, linearity, precision, accuracy, limit of detection and limit of quantification and robustness as per ICH guidelinesQ2(R1). The proposed method was found to provide faster retention time with sharp resolution with linearity at a lowest concentration as compared to previous methods and this method is validated as per International conference on harmonization guidelines and successfully applied for bulk and pharmaceutical dosage form.
Proton transfer reaction mass spectrometry (PTR-MS) allows for real time, online determination of absolute concentrations of volatile organic compounds (VOCs) with a high sensitivity and low detection limits (in the parts per trillion ranges). The technique utilizes H3O+ions for proton transfer reactions with many common VOCs while having little to no reaction with any constituents commonly present in it are detected by PTR-TOF .It combines the desirable attributes of high sensitivity and short integration times with good precision and accuracy . Medical applications by means of breath analysis allow the monitoring of metabolic processes in the human body, and examples of food research include investigations of volatile organic compound (VOC) emissions from fruit, coffee and meat. Investigations of VOC emissions from decaying bio-matter and on-line monitoring of the diurnal variations of VOCs in ambient air are typical examples of Environmental applications.
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