DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR DETERMINATION OF AN ASSOCIATION OF AMPICILLINS IN LYOPHILIZED POWDER FOR INJECTION BY HPLC

摘要

DEVELOPMENT AND VALIDATION OF ANALYTICAL METHOD FOR DETERMINATION OF AN ASSOCIATION OF AMPICILLINS IN LYOPHILIZED POWDER FOR INJECTION BY HPLC. An analytical method has been developed and validated for the determination of an association of ampicillins in a lyophilized powder for injection by HPLC. The advantage of chromatographic method other than the microbiological one is that, it is possible to monitor precisely, out-of-specification results in quality control processes and also during stability studies, in which an association of ampicillins is present. The proposed HPLC method was developed by using forced degraded samples, in order to reach a selective analysis of ampicillins when in the presence of their degradation products. It was possible to detect benzatine and through indirect calculation, to determine the ampicillin sodium in the drug sample. The method showed to be selective, accurate, precise, robust and linear (from 45.92 to 36.04 mu g mL(-1) of total ampicillin and from 14.53 to 43.28 mu g mL(-1) of benzatine). The accuracy determined from recovery test, gave results in the range of 99.41% of total ampicillin to 100.31% of benzatine. Hence, it can be concluded that the proposed HPLC method is applicable for ampicillins determination.