Quantitative determination of canagliflozin in human plasma samples using a validated HPTLC method and its application to a pharmacokinetic study in rats

Abstract

Canagliflozin (CNZ) is the first sodium-glucose co-transporter-2 inhibitor approved for treatment of type 2 diabetes mellitus. In the proposed work, a sensitive, rapid and validated high-performance thin-layer chromatography (HPTLC) method was established for the estimation of CNZ in human plasma for the first time. HPTLC analysis of CNZ and internal standard (sildenafil) was performed on glass coated silica gel 60 F 254 HPTLC plates using a binary mixture of chloroform-methanol 9:1 (%, v/v) as the mobile phase. Densitometric detection was done at 295 nm. Retardation factor values were obtained as 0.22 and 0.52 for the CNZ and the IS, respectively. The linearity range of CNZ was obtained as 200-3,200 ng/ml. A simple protein precipitation method was used for the extraction of analyte from plasma using methanol. The proposed HPTLC technique was validated for linearity, accuracy, precision and robustness. The proposed HPTLC technique was successfully utilized for the assessment of pharmacokinetic profile of CNZ in rats after oral administration. After oral administration, the peak plasma concentration of CNZ was obtained as 1458.01 ng/ml in 2 h. The proposed HPTLC method could be applied to the study of the pharmacokinetic profile of pharmaceutical formulations containing CNZ.

Application of experimental design in HPLC method optimization and robustness for the simultaneous determination of canagliflozin, empagliflozin, linagliptin, and metformin in tablet

“…A review of the literature revealed that different methods were reported for the estimation of GAG either alone (Alam et al, 2020) or in combination with other antidiabetic drugs (Sharif et al, 2020;van der Aart-van der Beek et al, 2020). Also literature review reveals different methods for the simultaneous estimation of CAG and MEF using spectrophotometric (Lotfy et al, 2018;Moussa et al, 2018;Wafaa et al, 2020) and HPLC methods (Gaware et al, 2015;Mohamed et al, 2019;Nalawade et al, 2020;Wattamwar et al, 2020).…”

Evaluation of influence of telmisartan on the pharmacokinetics and tissue distribution of canagliflozin in rats and mice

“…The UPLC-MS/MS method was successfully applied to study the influence of telmisartan on the pharmacokinetics and tissue distribution of canagliflozin. This LLE approach was used to process the biological samples due to its higher extraction recovery compared to that of previous LLE approaches and protein precipitation methods (18)(19)(20). Different LLE solvents, including ethyl acetate, dichloromethane, and methyl tert-butyl ether, were explored.…”

A Stability Indicating RP-HPLC Method Validation for Simultaneous estimation of Metformin HCl and Canagliflozin in Pharmaceutical Dosage Form

“…After reviewing the literature it can be said that very limited techniques are available for simultaneous estimation of Canagliflozin and Metformin HCl in FDC [14][15][16][17][18][19][20][21][22][23][24]. The previous methods are not that much of economic or sensitive so it was thought to develop simple, novel, sensitive and selective method.…”