A simple and sensitive high performance liquid chromatography assay with a fluorescence detector for determination of canagliflozin in human plasma

Abstract

Canagliflozin is the first sodium-glucose co-transporter-2 inhibitor approved for the treatment of type 2 diabetes mellitus. In this study, a simple and sensitive HPLC assay with a florescence detector was developed for accurate quantification of canagliflozin in human plasma using telmisartan as the internal standard (IS). Plasma samples were extracted by a liquid-liquid extraction method using diethyl ether as an extracting solvent. Chromatographic separation of canagliflozin and IS was performed on a Nucleodur Isis C 18 column with an isocratic mobile phase of 20 mM potassium dihydrogen orthophosphate : acetonitrile (45 : 55, v/v) at a flow rate of 1 mL min À1 . Canagliflozin and IS were eluted at 2.8 and 5.8 min, respectively, and detected at 280 and 325 nm for excitation and emission, respectively. The plasma calibration curve displayed excellent linearity over the concentration range of 16.13-6000 ng mL À1 . The assay was fully validated in terms of selectivity & specificity, linearity of the calibration curve, accuracy & precision, recovery and stability under various storage conditions. To the best of our knowledge, this is the first validated HPLC-florescence detector assay for the quantification of canagliflozin in human plasma.

Stability‐indicating chromatographic and chemometric methods for environmentally benign determination of canagliflozin and its major degradation product; A comparative study and greenness assessment

“…A thorough literature survey showed canagliflozin determination by HPLC methods in a pharmacokinetic study ( Devineni et al, ), a pharmaceutical formulation (Kaur, Wakode, Singh, & Manachanda, ) in rat plasma (Iqbal, Ezzeldin, Al‐Rashood, Asiri, & Rezk, ; Iqbal, Khalil, Alanazi, & Al‐Rashood, ; Kobuchi, Yano, Ito, & Sakaeda, ; Dong et al, ), in human plasma (Iqbal, Ezzeldin, et al, ; Iqbal, Khalil, et al, ; Dudhe & Kamble, ; Saibaba, Pilli, Bimireddy, & Pandiyan, ; Udhayavani, Sastry, Rajan, Tejaswi, & Rajani, ), and along with metformin (Gaware, Patil, & Harole, ; Zaghary, Mowaka, & Hendy, ). Canagliflozin was also determined by spectrophotometric (Kaur et al, ; Kaur, Wakode, & Singh, ) and TLC–densitometric methods (Kaur, Wakode, & Singh, ; Emam, ).…”

Inhibitory effects of sulfonylureas and non‐steroidal anti‐inflammatory drugs on in vitro metabolism of canagliflozin in human liver microsomes

“…A flow rate of 1 ml/min was used throughout the analysis. The volume of the injection was 20 μl, and the eluents were detected by a fluorescence detector at 280 nm excitation and 325 nm emission wavelengths according to the method of Iqbal, Khalil, Alanazi, and Al‐Rashood ().…”

Bioanalytical Method Development and Validation of Canagliflozin in Human Plasma by Liquid Chromatography–tandem Mass Spectrometry

“…Canagliflozin is classified as SGLT-2 inhibitor, a new class of antidiabetic drug having an insulin-dependent mechanism that offers a considerable advantage of increasing urinary glucose excretion without inducing hypoglycemia [2]. Several analytical methods such as ultraviolet [3], high-performance liquid chromatography (HPLC) [4][5][6][7], high-performance thin-layer chromatography [8], liquid chromatography-tandem mass spectrometry (LC-MS/MS) [9][10][11] have been developed for analysis of canagliflozin. There are methods developed for canagliflozin in rat plasma.…”