Validated Hptlc Method for Simulteneous Determination of Ceftriaxone Sodium and Sulbactam Sodium in Combined Dosage Form

Abstract

A simple, accurate and precise HPTLC method for simultaneous estimation of Cefoperazone sodium and Sulbactam sodium as bulk and dry powder for injection in combined dosages form is described in this paper. A mobile phase of Chloroform: Ethyl alcohol: Diethyl amine: Water (14: 16:8:1.2 v/v) was used after optimization at different concentrations for the development of densitogram. Aluminum plate coated with the silica Gel 60 F254 was used as stationary phase. Densitometric evaluation of the separated bands was performed at 274 nm. The Rf values of Cefoperazone sodium and Sulbactam sodium were 0.41 ± 0.01 and 0.56 ± 0.01respectively. The validated method was linear over the concentration range of 200 ng to 900 ng /spot and 400 ng to 1800 ng/spot of Cefoperazone sodium and Sulbactam sodium respectively. Precision of the method was evaluated by inerday and intraday RSD. The results were Cefoperazone sodium: Inter day RSD of peak response 1.25 % and Intraday RSD 1.73 % and for Sulbactam sodium Interday RSD of peak response 1.54 % and Intraday RSD 0.98 %. Accuracy was determined in terms of percentage recovery at three concentration levels for Cefoperazone sodium RSD 99.20 %, 99.50 % and 100.32 % and for sulbactam sodium RSD 101.25 %, 100.40 % and 100.60 % respectively. Specificity was determined by spectral analysis of cefoperazone sodium and sulbactam sodium and overlaying the standard spectra and sample spectra respectively .There was no any interference of mobile phase and diluents at the RF values of Cefoperazone sodium and sulbactam sodium. Validation was done in accordance with the ICH Guidelines.