A VALIDATED AND STABILITY INDICATING HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS ESTIMATION OF TERBUTALINE SULPHATE, GUAIPHENESIN AND BROMHEXINE HCL IN PHARMACEUTICAL FORMULATION

Safeena Sheikh, Suhail Asghar and Showkat Ahmad

A fast, rapid, sensitive and stability indicating high-performance thin-layer chromatographic (HPTLC) method is developed and validated for quantitative estimation of terbutaline sulphate (TS), Guaiphenasin (G) and Bromhexine hydrochloride (B.HCl) simultaneously in pharmaceutical formulation (Cough Syrup). The sample are chromatographed on silica gel 60F254- TLC plates, using solvent system Dichloromethane: Methanol: Acetic Acid (7.5: 1:0.5) and scanned at 254nm. The current method demonstrates good linearity over the range for TS was 200-1200ng/spot with r2 of 0.999; G is 1.0-6.0mcg/spot with r2 of 0.998 and B.HCl 500-3500ng/spot with r2 of 0.997. The average recovery of the method is 100.47% for TS; 99.94% for G and 100.12% for B.HCl in formulation. The limit of detection and limit of quantification for TS, G and B.HCl were found to be 50-150ng/spot, 200-800ng/spot and 100-300ng/spot respectively. The developed method was successfully applied for the assay of market formulation. The degree of reproducibility of the results obtained as a result of small deliberate variations in the method parameter and by changing analytical parameter operated proven that the method is robust.