Development and validation of an inductively coupled plasma mass spectrometry method for estimation of elemental impurities in calcium acetate active pharmaceutical ingredient

Abstract

A sensitive and selective method has been developed and validated for the simultaneous quantitative estimation of aluminum, magnesium, potassium, strontium and sodium in calcium acetate active pharmaceutical ingredient by inductively coupled plasma mass spectrometry. Inductively coupled plasma mass spectrometry is an advanced technique which is capable of analyzing multiple elements simultaneously with high selectivity, sensitivity and much lower detection limit. The test sample was prepared with microwave assisted acid digestion and introduced into optimized instrumental parameters for use of a quadrupole based Agilent 7800 inductively coupled plasma mass spectrometry instrument. Scandium is used as an internal standard in the study. The developed method was validated in terms of specificity, linearity, accuracy, precision, range, limit of detection, limit of quantitation and ruggedness. The results for recoveries of all elements were found between 85.3 to 103.9 %. The relative standard deviation for precision was within 15 %. Calibration plots were linear. The low relative standard deviation values and high recoveries of the method confirm the suitability of the method.