Development and Validation of UV Spectrophotometric Method for the Estimation of Canagliflozin in Bulk and Pharmaceutical Dosage Form
To develop and validate simple, sensitive, precise, rapid and cost effective method for determination of Canagliflozin in bulk and pharmaceutical formulations as per ICH Guidelines. A simple double beam UV Spectrophotometric method has been developed and validated with different parameters such as Linearity, Precision, Repeatability, Accuracy, Robustness and Ruggedness. Canagliflozin in phosphate buffer shows maximum absorbance at 289 nm. Beer's law was obeyed in the concentration range of 1 6 mcg ml 1. A recovery of Canagliflozin in tablet formulation was observed in the range of 80 120% Percentage assay of Canagliflozin tablets (INVOKANA(r) was found to be more than 99% The proposed method is precise, accurate and reproducible and can be used for routine analysis of Canagliflozin in bulk and pharmaceutical dosage form. Chinta Pooja* 1 Gurdeep Singh 1 Dharmesh Sisodiya 2 Department of Pharmaceutical Quality Assurance, Oriental College of Pharmacy Research, Oriental University, 1 Indore, Madhya Pradesh, India. Institute of Pharmacy, Vikram University, 2 Ujjain, Madhya Pradesh, India. Submission: 19 July 2018 Accepted: 27 July 2018 Published: 30 August 2018 www.ijppr.humanjournals.com Citation: Chinta Pooja et al. Ijppr.Human, 2018; Vol. 13 (1) 1 9. 2 INTRODUCTION Canagliflozin is an anti diabetic drug used to improve glycemic control in patients with type 2 diabetes. It inhibits sodium glucose cotransporter 2 (SGLT2) represent novel therapeutic approaches in the management they act on kidneys to decrease the renal threshold for glucose (RTG) and increase urinary glucose excretion (UGE) 1 3 Canagliflozin is chemically (2S,3R,4R,5S,6R) 2 {3 [5 (4 fluorophenyl) thiophen 2 ylmethyl] 4 methyl phenyl} 6hydroxymethyltetrahydro pyran 3,4,5 triol. 4 6 The structure of canagliflozin was shown in figure 1. It is white to off white solid with melting point of 95 105oC. Canagliflozin is soluble in phosphate buffer, methanol, dimethyl sulfoxide. Thereby increasing urinary glucose excretion and lowering blood glucose levels. It is a product of a division of Johnson and Johnson and marketed with the brand name of INVOKANA(r) in strengths of 100 and 300mg respectively. 7 Literature review revealed that they were several analytical methods like HPLC, LS MS, HPTLC and RP HPLC and only few UV Spectroscopic methods were reported for the estimation of canagliflozin in bulk and pharmaceutical dosage forms. Hence the present work aimed at the development and validates a simple, precise, sensitive UV spectrophotometric method for the estimation of Canagliflozin in its bulk and pharmaceutical dosage form. 8 10