METHOD DEVELOPMENT AND VALIDATION FOR ELEMENTAL IMPURITIES ANALYSIS OF MAGNESIUM STEARATE USP BY ICP-OES

ABM Mahfuz ul Alam*, Shahana Shilpi and M. I. R. Mamun

ABSTRACT

Method of analysis for determination of CADMIUM, LEAD & NICKEL in magnesium stearate USP was developed in inductively coupled plasma - optical emission spectrometry (ICP-OES). The Methods were found to be highly sensitive, selective, rapid, precise, accurate and affordable which can be followed by pharmaceutical industries. The method in ICP-OES was achieved at wavelength Cd (214.439 nm), Ni (231.604 nm) Pb (220.353 nm), with a measurement condition of Read time (s): 5, RF power (kW): 1.20, Stabilization time (s): 15, Nebulizer flow (L/min): 0.70, Plasma flow (L/min): 12.0, Aux flow (L/min): 1.00, Make up flow (L/min): 0.00, Viewing mode: Radial, Viewing height (mm): 8, Use multiple conditions: 2, Viewing mode: Axial. The method was validated as per ICH guidelines for Accuracy, Precision, Ruggedness, LOD and LOQ which showed that proposed method was simple, sensitive, and highly robust for routine analysis.

Keywords: ICP-OES, Magnesium Stearate, Elemental Impurities, Method Validation.