Abstract

VALIDATION OF ANALYTICAL METHOD OF ESTIMATION OF SODIUM IN API WITH THE HELP OF NMR SPECTROSCOPY

Partha Mukherjee*, Prasant K Deb, Kartikewa Dwivedi

Abstract

A simple, specific, sensitive method was developed and validated in NMR spectroscopy to know the percentage of sodium present as salt or as inorganic impurity in API and drug molecule. Unlike the Q-NMR studies where internal standards were mixed with the compound of interest, in this study standard and analyte solution were prepared separately and recorded in 400 MHz equipped with broadband probe. The method was validated by the recommendation mentioned in the ICH guidelines. Sodium chloride (NaCl) was taken as internal standard to draw the standard calibration curve (0.35 mg/ml -2.74 mg/ml). The concentration of the unknown solution was determined by comparing its integration value with the standard curve.

Keywords: Q-NMR, internal standard.