A NOVEL ASSAY METHOD OF 1-DEOXY NOJIRIMYCINE (DNJ) BY ION CHROMATOGRAPHYAbstract
A novel Assay method for the determinationof1-Deoxy nojirimycine(DNJ) was proposed by the authors using ion chromatography. The method was found to be accurate, simple and precise. A method precision RSD of 0.5%, RSD for intermediate precision of 0.6% and correlation coefficient was found to be 0.9999. A recovery of 99.7 to 100.1% at 50%, 100% and 150% levels was found. The DNJ solutions and mobile phase were found to be stable up to 48 hrs. The robustness study was found that the method was robust at low flow, high flow, low strength and high strength. Specificity of DNJ with other cations and organic bases were not interfered. The peak of DNJ was homogeneous, this specificity of peak homogeneity study was performed with UPLC-TOF by collecting peak of DNJ from detector end of Ion chromatography. All analytical parameters were performed by using ICH guidelines.
Nagaraju Rajana*, Rubia Lasker, Venkatesh P, Kaviraj Yarbagi, Balakumaran K and J. Moses Babu
Analytical Research, Custom Pharmaceutical Services, Dr. Reddy’s Laboratories Ltd., Bollaram road, Miyapur, Hyderabad (TS), India.
22 October, 2015
09 December, 2015
22 January, 2016
01 April, 2016