Journal of Analytical & Bioanalytical Techniques
Open Access

Abstract

A rapid, accurate, 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 F 254 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 237 nm. 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- 12000 ng/band for AMOX and 500-2500 ng/band 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.

Biography

Sohan S. Chitlange has completed his Master?s degree from University department of Pharmaceutical Sciences, Nagpur University, Nagpur and doctoral degree from Sant Gadge baba Amravati University, Amravati. He is a recipient of G. B. Singh Gold medal award & Husseni Daginwala Gold medal award for first merit at M.Pharm from Nagpur University. He has around 14 years of professional experience and has published more than 64 research papers in national & international journals of repute. He is editorial board member for Indian Pharma Pulse review & reviewer for various national & international journals. He is member, board of studies: Pharmaceutical Chemistry, faculty of pharmaceutical sciences, University of Pune, Executive council member, Association of Pharmacy Teachers of India (MS branch) and Executive committee member, Association of unaided private Pharmacy colleges (AUPPC).