Formulation of Dapagliflozin and Saxagliptin Tablets and In vitro Evaluation by RP-HPLC Method

Abstract

Dapagliflozin and Saxagliptin is an efficient combination for the treatment of Type 2 diabetis introduced in 2017. No reports are available on the formulation of Dapagliflozin and Saxagliptin combined drug tablets. The objective of the present study is to formulate Dapagliflozin and Saxagliptin combined drug tablets and to perform their In vitro evaluation by an RP-HPLC method. Tablets each containing 10mg of Dapagliflozin and 5mg of Saxagliptin were formulated employing commonly used tablet excipients (lactose, dicalciumphosphate, Starch 1500 and β-cyclodextrin) and the tablets were prepared by direct compression method. All the prepared tablets and one commercial brand (Qtern) were evaluated for hardness, friability, disintegration time, content of active ingredients and dissolution rate of Dapagliflozin and Saxagliptin. An RP-HPLC method was used for simultaneous determination of Dapagliflozin and Saxagliptin content in the tablets and in the in vitro dissolution samples. Tablets of Dapagliflozin (10mg) and Saxagliptin (5mg) could be prepared employing commonly used tablet excipients (lactose, dicalcium phosphate, Starch 1500, β-cyclodextrin) by direct compression method. The physical parameters of the tablets prepared (hardness, friability, content of active ingredient and disintegration time) are comparable with those of commercial tablets, Qtern. Formulation F1 prepared using lactose as excipient gave dissolution similar to Qtern with regard to both Dapaliflozin and Saxagliptine. Formulations F3 and F4 which contain Starch 1500 and βCD respectively as excipients gave higher dissolution than Qtern tablets. Formulation F1 is considered equivalent to Qtern and formulations F3 and F4 are considered superior to Qtern. An RP-HPLC method could be used to estimate the content of Dapaliflozin and Saxagliptine in the tablets and also in dissolution samples.