Original Articles: 2010 Vol: 2 Issue: 4
Validation of Spectrophotometric Methods for Quantitative Determination of 7-ADCA in Pharmaceutical Formulations
Abstract
Two simple, sensitive and accurate methods are described for the determination of 7-Amino deacetoxy cephalosporanic acid (7-ADCA) in bulk drug and in formulations. Method M1&M2 are based on the oxidizing reaction between 7-ADCA and Ninhydrin-Ascorbic acid (NIN-AA) (M1); β-Napthol-H2O2-Cupric nitrate-2, 4-DNP-Ammonium hydroxide (β-NPT,H2O2-DNP)(M2) solutions. The chromogen being extractable with chloroform could be measured quantitatively at 400 nm (M1) and 420 nm (M2). All variables were studied to optimize the reaction conditions. Regression analysis of Beer's Law plot showed good correlation in the concentration range 0.5- 3.0 for M1and 0.8-4.8 for M2 mg/ml. The calculated molar absorptivity values are 6.701´104 and 7.015´104 L/mol/cm for M1 and M2, respectively. The methods were successfully applied to the determination of 7-ADCA in formulations and the results tallied well with the label claim. The results were statistically compared with those of a literature method by applying the Student’s ttest and F-test. No interference was observed from the concomitant substances normally added to preparations. The accuracy and validity of the methods were further ascertained by performing recovery experiments via standard-addition method