A NEW POLARIMETERIC METHOD FOR THE ANALYSIS OF SUCROSE – IN IRON SUCROSE RAW MATERIAL, IRON SUCROSE INJECTION AND INPROCESS BULK FORMULATIONSAbstract
A simple, sensitive, rapid, accurate and economical polarimeteric method has been developed and subsequently validated for simultaneous determination of Sucrose – in Iron Sucrose Raw material, Iron Sucrose Injection and Inprocess Bulk sample of Iron Sucrose formulations in pharmaceuticals. The usual measure of purity of sucrose is by polarimetry – the measurement of the rotation of plane-polarized light by a solution of sucrose. The specific rotation at 20°C using yellow “sodium-D” light (589 nm) is +66.47°. Commercial samples of sucrose are assayed using this parameter. Readings are not affected by the molecular weight of the Iron Sucrose, the entire procedure takes much less time to perform. The developed method was compared with RP-HPLC method. The described method was linear over a concentration range of 10-70 mg per ml for the assay of Sucrose. Results of analysis were validated statistically and by recovery studies. The limit of detection (LOD) and the limit of quantification (LOQ) for Sucrose were found to be 0.076 and 0.231mg per ml. The results of the study showed that the proposed polarimeteric method is simple, rapid, precise, accurate and economical (as compared to conventional RP-HPLC methods) which is useful for the routine determination of Sucrose.
Hemant Desai*, Manan Sevak, Vipul Panchal, Kalpesh Panchal and Nirav Patel
Nirlife Healthcare (Healthcare Division of Nirma Limited), Sachana, Ahmedabad-382 150, Gujarat, India
20 March, 2013
22 May, 2013
15 July, 2013
01 August, 2013