Stability evaluation of amoxicillin in a solid premix veterinary formulation by monitoring the degradation products through a new HPLC analytical method.
A methodology (by VICH guidelines) for the stability evaluation of amoxicillin in granular premixes is described. This method is based on the monitoring of the degradation products formed during the stability study by a new HPLC-RP method, which has been developed and validated for the simultaneous determination of amoxicillin and its degradation products. The method uses a Nucleosil 120 C18 column and gradient elution. The mobile phase consisted of a mixture of methanol and buffer solution pH 3+/-0.05 at different proportion according to a time-schedule programme, pumped at a flow rate of 1.750 ml min(-1). The DAD detector was set at 230 nm. The validation study was carried out fulfilling the VICH guidelines in order to prove that the new analytical method, meets the reliability characteristics, and these characteristics showed the capacity of analytical method to keep, throughout the time, the fundamental criteria for validation: selectivity, linearity, precision, accuracy, sensitivity (LOD, LOQ) and robustness. The method was applied during the stability study of an amoxicillin premix in order to quantify the drug (amoxicillin) and all its degradation products to evaluate the shelf life of the new veterinary dosage form. The method also proved to be suitable as a rapid and reliable quality control method.
Pérez-Lozano
P
P
Unit of Pharmaceutical Technology, Pharmacy and Pharmaceutical Technology Department, School of Pharmacy, University of Barcelona, Avda Joan XXIII s/n 08028, Barcelona, Spain. perezlo@ub.edu
García-Montoya
E
E
Orriols
A
A
Miñarro
M
M
Ticó
J R
JR
Suñé-Negre
J M
JM
D000658:Amoxicillin / Q000032:analysis / Q000592:standards; D000900:Anti-Bacterial Agents / Q000032:analysis / Q000592:standards; D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000662:veterinary; D004355:Drug Stability; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D000900:Anti-Bacterial Agents; D000658:Amoxicillin