Forced Degradation Tests of Ampicillin in Medication Forms

Ampicillin is a β lactam antibiotic having broad spectrum having activity against Gram +ve, Gram –ve bacteria as well as enterococci. It is indicated for respiratory tract, urinary tract and soft tissue susceptible infections. Forced degradation commonly includes exposure of drug to heat, range of pH values, UV light. forced degradation study helps to determine the loss of drug substance and the degradation product under diverse conditions. According to ICH guidelines Ampicillin was exposed to different stress conditions. For the analysis of drug in the presence of degradation products, UV spectroscopic method was developed which calculate the amount of the degraded product. According to the BP, the official assay limit of the content should NLT 95% and NMT 105% of labelled amount. AMP, AMP.L, AMP.M on exposure to acidic (1 N HCl) and basic (1 N NaOH) medium shows heavy degradation. However, when AMP, AMP.L, AMP.M are exposed to heat and UV light negligible difference in availability was determined. After 8 days, the effect of time shows that AMP shows no degradation whereas AMP.L and AMP.M shows less degradation as compared to other stress degradation factors. The method was found to be simple, cost effective and less time consuming. Hence this method can be successfully used.

Keywords:

Ampicillin , Degradation Studies , API , Formulations