Stability- Indicating HPTLC densitometric method for determination of Metformin hydrochloride in tablet formulation

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DOI: 10.4103/2231-4040.197331

A simple, selective, precise and stability-indicating high-performance thin-layer chromatographic method of analysis of metformin hydrochloride both as a bulk drug and in formulation was developed and validated. The method employed HPTLC aluminium plates precoated with silica gel 60F254 as the stationary phase. The solvent system consisted of water: methanol: tri-ethylamine (1:3.5:0.2 v/v). The system was found to give compact spot for metformin hydrochloride (RF value of 0.48±0.02). Densitometric analysis of metformin hydrochloride was carried out in the absorbance mode at 247 nm. The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9965 ± 0.0013 with respect to peak area in the concentration range 100–600 ng per spot. The mean value ± S.D. of slope and intercept were 9.047 ± 0.11 and 553.0 ± 39.06 with respect to peak area. The method was validated for precision, recovery and robustness. The limits of detection and quantitation were 9.40 and 28.51 ng per spot, respectively. Metformin hydrochloride was subjected to hydrolysis (in acid, alkali, and neutral solutions), oxidation and photo- degradation. The drug undergoes degradation under acid, alkali, neutral, H2O2, and photolytic conditions. This indicates that the drug is susceptible to hydrolysis, oxidation and photo degradation. Statistical analysis proves that the method is selective, precise and accurate for the estimation of said drug. The proposed developed HPTLC method can be applied for identification and quantitative determination of metformin hydrochloride in bulk drug and dosage forms.

Keywords: Metformin hydrochloride, HPTLC, Stability, Tablet.