Validated Hptlc Method for Simulteneous Determination of Citicoline sodium and Piracetam in Combined Dosage Form

Abstract

A simple, accurate and precise HPTLC method for simultaneous estimation of Citicoline sodium and Piracetam in a bulk and in combined dosages form is described in this paper. After optimization a mobile phase of Methanol: Water (16:4 v/v) was used during validation of an analytical method. Aluminum plate coated with the silica Gel 60 F254 was used as stationary phase. Densitometric evaluation of the separated bands was performed at wavelength 212 nm. The Rf values of Citicoline sodium and Piracetam were 0.30 and 0.68 respectively. The validated method was linear over the concentration range of 400 ng to 3200 ng /spot and 1200 ng to 3600 ng/spot of Citicoline sodium and Piracetam respectively. Precision of the method was evaluated by inerday and intraday RSD. The results were Citicoline sodium: Inter day RSD of peak response 0.62 % and Intraday RSD f peak response 1.05 % and for Piracetam : Interday RSD of peak response 1.44 % and Intraday RSD of peak response 1.06 %. Accuracy was determined in terms of percentage recovery at three concentration levels. The results are for Citicoline sodium: 97.66 %, 99.70 % and 97.91 % and for Piracetam: 98.52 %, 97.61 and 96.64 % respectively. Specificity was determined by spectral analysis of Citicoline sodium and Piracetam and overlaying the standard spectra and sample spectra respectively .There was no any interference of mobile phase and diluents at the Rf values of Citicoline sodium and Piracetam. Validation was done in accordance with the ICH Guidelines.