TWO-DIMENSIONAL TLC METHOD FOR IDENTIFICATION AND QUANTITATIVE ANALYSIS OF SALBUTAMOL AND RELATED IMPURITIES IN PHARMACEUTICAL TABLET FORMULATION

A rapid and sensitive TLC method was developed and validated for the analysis of salbutamol and identification of its related impurities compounds. Spectro-densitometric scanningintegration was performed at an absorbance wave length of 254 nm. To justify the suitability of the proposed method, accuracy, precision and recovery studies were performed at three selected concentrations levels. The recovery data reveals that the RSD for intra-day and interday analysis were found to be 4.86 and 1.23%, respectively. A TLC plastic plate precoated with silica gel was used as the stationary phase. The solvent system was acetonitrile : methanol : ammonium hydroxide (10 : 85 : 5 v/v/v) gave a dense and compact spots of salbutamol and related impurities compounds namely: isopropyl salbutamol, desoxy salbutamol base, salbutamol ketone hydrochloride and 5-formyl saligenin salbutamol with a Rf values of 0.1, 0.26, 0.35, 0.54 and 0.75 respectively. The calibration plots exhibited good linear relationship (r = 0.9996) over a concentration range of 5–25 mg/ml. Statical analysis proved that the proposed method is accurate and reproducible. The method is stability indicating and being economical can be employed for the routine analysis of the bulk material of salbutamol and its pharmaceutical tablets formulations.