STABILITY INDICATING RP-HPLC METHOD FOR ESTIMATION OF TWO SYNTHETIC ANTIBIOTICS, AMOXICILLIN AND ENROFLOXACIN, SIMULTANEOUSLYAbstract
This work proposes a precise, accurate, sensitive and selective stability indicating RP-HPLC method for the simultaneous quantification of amoxicillin and enrofloxacin in bulk powder and oral suspension formulations. Chromatographic separation was performed on the reverse phase C18 analytical column using 0.1M potassium dihydrogen orthophosphate–methanol (65:35, v/v) as mobile phase and with detection at 235 nm. The retention times of amoxicillin and enrofloxacin were 3.364 min and 6.604 min, respectively. The linearity ranges were found to be 38.5-115.5-10 µg/ml (for amoxicillin) and 17.5-52.50 µg/ml (for enrofloxacin). The developed method was validated following International Conference on Harmonization guidelines. All validation parameters are fulfilled by the proposed method. Amoxicillin and enrofloxacin was subjected to different stress conditions like acid, alkali, oxidation, thermal, photo, and hydrolytic degradation. Both the analytes undergo degradation in all stress conditions. Since, the method effectively separated the analytes from their degradation products, it can be used as a stability-indicating method.
S. Anwar * and P. M. A. A. Khan
Department of Analytical Research and Development, Mylan Laboratories Limited, Hyderabad, Telangana, India.
05 April 2019
21 September 2019
06 November 2019
01 January 2020