Simultaneous Estimation and Validation of Levocetirizine, Pseudoephedrine and Ambroxol in Bulk and Combined Tablet Dosage Form by HPTLC.

Abstract

Objective: To develop and subsequently validate a new simple and sensitive high performance thin layer chromatographic (HPTLC) method for estimation of Levocetirizine, Pseudoephedrine and Ambroxol simultaneously, from a bulk drug and combined dosage form. Method: The separation of drugs was carried out on Merck HPTLC aluminium sheets of silica gel 60 F254 as stationary phase and the chromatogram was developed using Ethyl-acetate: methanol: ammonia (8: 1: 0.5 v/v/v) as the mobile phase. Result: Levocetirizine, Pseudoephedrine and Ambroxol showed Rf values 0.1 ± 0.02, 0.39 ± 0.05, and 0.73 ± 0.05 respectively, when scanned densitometrically at 212 nm using Camag TLC Scanner. The described method was linear over a concentration range of 100 ng spot-1 to 700 ng spot-1, 600 ng spot-1 to 4200 ng spot-1 and 1200 ng spot-1 to 8400 ng spot-1 for the Levocetirizine, Pseudoephedrine and Ambroxol respectively. Results of analysis were validated according to International Conference on Harmonization ICH Q2B guidelines statistically, and by recovery studies. The limit of detection (LOD) for Levocetirizine, Pseudoephedrine and Ambroxol were found to be 25 ng spot-1, 40 ng spot-1 and 35 ng spot-1 respectively. The limit of quantification (LOQ) were found to be 60 ng spot-1, 87 ng spot-1 and 71 ng spot-1 for Levocetirizine, Pseudoephedrine and Ambroxol respectively. Conclusion: The results of the study showed that the proposed HPTLC method is simple, rapid, precise and accurate, which is useful for the routine determination of Levocetirizine, Pseudoephedrine and Ambroxol bulk drug and in its pharmaceutical dosage form