DEVELOPMENT AND VALIDATION OF HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHY METHOD FOR SIMULTANEOUS ESTIMATION OF AMBROXOL HYDROCHLORIDE AND DESLORATADINE HYDROCHLORIDE IN THEIR COMBINED TABLET DOSAGE FORM
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 5
Abstract
The present manuscript describes new, simple, accurate, and precise high performance thin layer chromatography method for the simultaneous determination of Ambroxol Hydrochloride and Desloratadine Hydrochloride in combined tablet dosage form. Chromatographic separation of the drugs was performed on aluminium plates pre coated with silica gel 60 F254 as the stationary phase and the solvent system consisted of Chloroform: Ethyl Acetate: Methanol: Tri ethylamine (6: 4.5: 2.5: 0.8, v/v/v/v). Densitometric evaluation of the separated zones was performed at 245 nm. The two drugs were satisfactorily resolved with Rf values 0.72 and 0.26 for Ambroxol Hydrochloride and Desloratadine Hydrochloride, respectively. The linear regression data for the calibration plots showed good relationship with r2 = 0.99886 from 1500 – 5250 ng/spot for Ambroxol Hydrochloride and r2 = 0.99875 from 100 – 350 ng/spot for Desloratadine Hydrochloride. The methods were validated for precision, accuracy, and recovery. The percentage recovery for Ambroxol Hydrochloride was found to be 99.92 – 100.20 % and 99.73 – 100.18 % for Desloratadine Hydrochloride. The limits of detection and quantification were 201.26 and 609.87 ng/spot per spot for Ambroxol Hydrochloride and 14.05 and 42.57 ng/spot per spot for Desloratadine Hydrochloride, respectively.
Authors and Affiliations
Ekta Sharma , Nehal Shah
Keywords
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