Method development, validation and comparative study of generic Vs. branded generic formulations of amoxicillin trihydrate in capsule dosage form

摘要

The present work relates to development and validation of simple, precise and sensitive UV spectrometric and high-performance thin layer chromatographic (HPTLC) method for the analysis of Amoxicillin Trihydrate in Capsule dosage form. Method were developed and applied for comparative study of generic vs branded generic formulations of Amoxicillin Trihydrate. Amoxicillin Trihydrate in methanol shows maximum absorbance at 229 nm and the data of linear regression analysis indicated a good linear relationship over the concentration range of 5-30 μg/ml with a correlation coefficient (Rsup2/sup) 0.998 by UV- Spectroscopy and the concentration range of 2000-12000 ng/band with a correlation coefficient (Rsup2/sup) 0.997 by HPTLC. The main objective was to compare and evaluate the price and quality of branded generic and generic formulations of Amoxicillin Trihydrate 250 mg Capsule. The evaluation parameters like content of active ingredients, content uniformity test, mass variation, disintegration test, and in vitro release studies were performed as described in Indian Pharmacopeia 2010.