Development and validation of HPTLC method for simultaneous estimation of canagliflozin and metformin hydrochloride in bulk and tablet dosage form
Keywords: metformin hydrochloride, canagliflozin, HPTLC, validation
AbstractThe discovery of new drug combinations and the ongoing update of international regulations for the safety and efficacy of pharmaceutical formulation, demand the development of new analytical methods for these combinations. Combined-dose tablet formulation containing metformin hydrochloride (MET) and canagliflozin (CANAG) has recently been introduced in the market and a literature survey revealed a limited number of high-performance liquid chromatography (HPLC) and spectrophotometric methods reported, but no high-performance thin-layer chromatographic (HPTLC) method for the simultaneous estimation of these drugs in pharmaceutical formulation. The present work describes the development and validation of an HPTLC method for the simultaneous determination of MET and CANAG in a combined dosage formulation. The chromatography was performed on pre-coated silica gel 60 F 254 plates using methanol : toluene : ethyl acetate : ammonia (2 : 4 : 4 : 0.1) as mobile phase. A thin layer chromatographic (TLC) scanner set at 254.0 nm was used for direct evaluation of the chromatograms in reflectance/absorbance mode. The drugs were satisfactorily resolved with Rf 0.15 for MET and 0.50 for CANAG. The method was validated according to The International Council on Harmonisation (ICH) guidelines. The calibration plot was linear between 0.5–3.0 μg/band for MET and 50–300 ng/band for CANAG respectively. Accuracy and precision of the proposed method were evaluated by recovery studies and intra-day and inter-day precision studies respectively. In stability testing, MET and CANAG were found to be susceptible to acid hydrolysis and alkaline degradation. Because the method could effectively separate the drugs from their degradation products, it may be used as a stability-indicating method.
Basic pharmaceutical science/Pharmacognosy
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