Development of new Validated HPTLC Method for simultaneous estimation of Canagliflozin and Metformin in Tablet Formulation

Abstract

A new HPTLC method for simultaneous determination of Canagliflozin and Metformin was developed, validated and compared with the reported one. An excellent resolution with Rf values 0.21±0.02 and 0.50±0.03 for Metformin and Canagliflozin respectively was achieved by using optimized chromatographic conditions. Toluene: Methanol: Triethyl amine: Glacial Acetic acid (7:2.6:0.2:0.2, v/v/v/v) was chosen as a mobile phase. Detection was done at 254nm. When marketed formulation was analyzed by developed method, the % drug contents were found to be 98.20±0.24 and 99.33±1.80% w/w for Metformin and Canagliflozin respectively. Developed method was validated for linearity and range, DL, QL, accuracy, precision, robustness and specificity. The method was found to be linear, accurate, precise, robust and sensitive. The method was found to be linear in a range of 75-750ng/band of Canagliflozin with R2 value 0.9981 and 250-2500ng/band of Metformin with R2 value 0.9963. Detection and quantitation limits were found to be 8.01 and 24.28ng/band for Metformin and 8.27 and 25.07ng/band for Canagliflozin respectively. The % drug recovery was calculated as a measure of accuracy. The % drug recovery was found to be near to 100 %w/w confirmed the accuracy of the method. In case of precision studies, %RSD values were found to be less than two indicated, the method is precise. The % RSD values of deliberate variations like amount of mobile phase, saturation time were found to be less than two showed method is robust. The developed method was compared with the reported method and found to be more linear, accurate, precise and sensitive.