Development and Validation of Stability Indicating HPTLC Method for Simultaneous Estimation of Metformin Hydrochloride and Remogliflozin Enabonate in Pharmaceutical Dosage Form
Abstract
Abstract A novel and quick HPTLC-densitometric method was developed for the simultaneous determination of Metformin Hydrochloride and Remogliflozin Enabonate. Chromatographic separation of the drugs was performed on precoated silica gel aluminium plate 60F254, (20×10) 100µm thickness; using Methanol: Ethyl Acetate: Acetic Acid (6:3.5:0.5v/v) as mobile phase. A TLC scanner set at 245 nm was used. The two drugs were satisfactorily resolved with Rf values Rf 0.23 for MET and Rf 0.83 for REMO respectively. Calibration curves were polynomial in the range concentration range of 200-1200ng/band for Remogliflozin Enabonate and 1000-6000ng/band for Metformin Hydrochloride. Correlation coefficients (r) values were 0.9999, 0.9999,for Metformin Hydrochloride and Remogliflozin Enabonate respectively. A low relative standard deviation (< 2%) was found for both precision and robustness study showing that the proposed method was precise and robust. The method had an accuracy of 98.82%, 98.42% of Metformine Hydrochloride and Remogliflozin Enabonate were validated according to ICH guidelines. The percentage recovery ranges from 98–101%. Forced degradation conditions of hydrolysis (neutral, acidic and alkaline), oxidation, photolysis and thermal stress, as suggested in the ICH guideline Q1A (R2).
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