STABILITY INDICATING HPTLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF AMBROXOL HYDROCHLORIDE AND CETIRIZINE DIHYDROCHLORIDE IN COMBINE TABLET DOSAGE FORM
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2011, Vol 2, Issue 3
Abstract
A new simple, sensitive and precise high performance thin layer chromatographic method has been developed for estimation of Ambroxol hydrochloride and Cetirizine dihydrochloride simultaneously from a combined Solid dosage form.In this method pre coated silica gel 60 GF 254 TLC plate was used as stationary phase and the chromatogram was developed using CCl4: Chloroform: Methanol (3:5:2v/v/v) as mobile phase. Ambroxol hydrochloride and Cetirizine dihydrochloride showed Rf values 0.74 ± 0.2, 0.47 ± 0.2 respectively. The plate was scanned and quantified at 230 nm using Camag TLC Scanner. The linear concentration 240-720ng/band and 20-60 ng/band for Ambroxol hydrochloride and Cetirizine dihydrochloride respectively. The percentage recovery for Ambroxol hydrochloride and Cetirizine dihydrochloride was found to be 100.08 % , 101.21%. As the method could effectively separate the drug from its degradation product it can be employed as stability indicating one. The method is validated as per ICH guidelines.
Authors and Affiliations
Advaita Patel , Sanket Patel , Deepa Patel , Bhavesh Patel , Madhabhai Patel
Keywords
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