Фармацевтика Аналитика Акта

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Stability-Indicating HPTLC Method for Simultaneous Estimation of Amoxicillin Trihydrate and Ambroxol Hydrochloride in Bulk and Pharmaceutical Dosage Form

Sohan S Chitlange, Sneha R Tawargeri and Ritesh P Bhole

A rapid, precise, selective and sensitive HPTLC method for simultaneous determination of Amoxicillin trihydrate (AMOX) and Ambroxol hydrochloride (AMBRO) in pharmaceutical dosage form was developed and validated in the present work. The chromatographic separation was performed on precoated silica gel 60 F₂₅₄ plates with Ethyl acetate: methanol: toluene: water: glacial acetic acid (6.0: 3.0: 2.0: 1.0: 0.5 v/v) as the mobile phase with UV detection at 237nm. Retention factor for AMOX and AMBRO were found to be 0.32 ± 0.04 and 0.70 ± 0.05 respectively. Linearity was observed in the concentration range of 2000-12000ng/band for AMOX and 500-2500 ng/b and for AMBRO and the coefficient of regression for both the drugs was 0.9986 and 0.995 respectively. The method was validated for precision, robustness, and recovery and the values obtained were within the ICH limits. The LOD and LOQ values for AMOX were 105 and 220 ng per band respectively and for AMBRO 50 and 120 ng per band respectively. Drugs were subjected to oxidation, acid hydrolysis, base hydrolysis and sun light to apply stress condition for degradation studies as per ICH guidelines. The degradation products were well resolved from the pure drug with significantly different Rf values. Since the method could effectively separate the drug from its degradation products, it could be used as a stability-indicating method for analysis of individual drugs and the combined dosage form.