Original Articles: 2015 Vol: 7 Issue: 7
Development and validation of HPTLC method for simultaneous estimation of Ambroxol hydrochloride, Phenylephrine hydrochloride, Chlorpheniramine maleate, Paracetamol and Guaiphenesin in pharmaceutical formulation
A simple, sensitive, accurate, precise and robust high performance thin layer chromatographic method for simultaneous quantification of Ambroxol hydrochloride, Phenylephrine hydrochloride, Chlorpheniramine maleate, Paracetamol and Guaiphenesin in tablet dosage form has been developed and validated. Chromatographic separation was carried out on Merck precoated aluminium plates with silica gel 60 F254 as the stationary phase. It is a double development method in which first optimized mobile phase used was ethyl acetate for Paracetamol and Guaiphenesin. Second mobile phase used was toluene: methanol: glacial acetic acid (1.4:8.3:0.3, v/v/v) for Ambroxol hydrochloride, Phenylephrine hydrochloride, Chlorpheniramine maleate. Detection wavelength was carried out at 277nm in reflectance/absorbance mode. The retardation factors were found to be 0.82±0.02 for Ambroxol hydrochloride, 0.67±0.02 for Phenylephrine hydrochloride, 0.12±0.02 for Chlorpheniramine maleate, 0.63±0.02 for Paracetamol and 0.47±0.02 for Guaiphenesin. Developed method was validated as per ICH Q2 (R1) guideline. Linearity range for AMB was found to be 1000-10000 ng band-1, for PHE 200-2000 ng band-1, for CPM 100-1000 ng band-1, for PARA 100-1000 ng band-1 and that of GUA 500-3000 ng band-1. The tablet dosage form was found to contain 99.41% (w/w) AMB, 99.77% (w/w) PHE, 100.37% (w/w) CPM, 100.98% (w/w) PARA and 100.44% (w/w) GUA.