DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF CETRIZINE HYDROCHLORIDE AND AMBROXOL HYDROCHLORIDE IN COMBINED TABLET DOSAGE FORM
Yogesh Gandhi, Padmanabh Deshpande*, Neha Deore, Ganesh Sarowar and Janvi Bhatt
ABSTRACT
The present study describes development and validation of a simple, accurate, precise and selective stability-indicating high performance thin layer chromatographic method for simultaneous estimation of Cetrizine hydrochloride and Ambroxol hydrochloride in combined tablet dosage form. Chromatographic separation of both the drugs was carried out by using silica gel 60F254 as stationary phase and Ethyl acetate: Methanol: Ammonia in the ratio of (8: 1.5: 0.5, v/v/v) as mobile phase. Densitometric detection was carried out at 222 nm. The two drugs were satisfactorily resolved with Rf values of 0.30 ± 0.06 for Cetrizine hydrochloride and 0.71 ± 0.03 for Ambroxol hydrochloride. The developed method was validated in terms of linearity, accuracy, precision and robustness as per ICH guidelines. The drugs were subjected to forced degradation studies under condition of hydrolysis (acid, base), oxidation, photolysis and thermal stress. Results were found to be linear in the concentration range of 25-150 ng band-1 for Cetrizine hydrochloride and 300-1800 ng band-1 for Ambroxol hydrochloride. The method has been successfully applied for the estimation of drugs in tablet dosage form. The % assay (Mean ± S.D.) was found to be 100.62 ± 1.45 for Cetrizine hydrochloride and 100.37 ± 0.95 for Ambroxol hydrochloride. The developed method can be used efficiently for routine quality control analysis of both the drugs as bulk and in combined tablet dosage form.
Keywords: Cetrizine, Ambroxol hydrochloride, HPTLC, Forced degradation, Tablet dosage form.
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