DEVELOPMENT AND VALIDATION OF TLC DENSITOMETRIC METHOD FOR THE STABILITY INDICATING STUDY OF METOPROLOL SUCCINATE AND HYDROCHLOROTHIAZIDE IN TABLET DOSAGE FORM

Accurate, specific, precise and robust TLC Densitometric method have been developed for simultaneous estimation of Metoprolol Succinate (METO) and Hydrochlorothiazide (HCTZ) in tablet dosage form. The chromatographic separation was performed on precoated silica gel TLC 60 F254 plates using Toluene: Methanol: Ethyl acetate: Glacial acetic acid (7: 1.5: 1: 0.5 v/v/v/v) as mobile phase. This system was found to give compact bands for Metoprolol Succinate and Hydrochlorothiazide (RF values 0.15 and 0.35 respectively). Densitometric analysis of Metoprolol Succinate and Hydrochlorothiazide were performed at 230 nm. Regression analysis data for the calibration plots were indicative of good linear relationships between response and concentration over the range 1000-5000 ng/band for Metoprolol Succinate and 500-2500 ng/band for Hydrochlorothiazide. An approach of forced degradation study was successfully applied for the development of a stability-indicating method for estimation of Metoprolol Succinate and Hydrochlorothiazide in the presence of its degradation products. The method was validated as per ICH guidelines for accuracy, precision, LOD, LOQ and robustness. Keywords: Metoprolol Succinate (METO), Hydrochlorothiazide (HCTZ), TLC Densitometric.