Manuscript Title:

METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF ELEMENTAL IMPURITIES IN BILASTINE ACTIVE PHARMACEUTICAL INGREDIENT BY INDUCTIVELY COUPLED PLASMA MASS SPECTROMETRY

Author:

JERRI P VENKATA KRISHNA, Dr.S. RAJASEKARAN

DOI Number:

DOI:10.17605/OSF.IO/43V6T

Published : 2022-04-23

About the author(s)

1. JERRI P VENKATA KRISHNA - Research Scholar, Bhagwant University, Ajmer, Rajasthan, INDIA-305004.
2. Dr.S. RAJASEKARAN - Faculty of Pharmacology, Bhagwant University, Ajmer, Rajasthan, INDIA.

Full Text : PDF

Abstract

Bilastine active pharmaceutical ingredient was simultaneously quantified by inductively coupled plasma mass spectrometry using sensitive and selective technique. Inductively coupled plasma mass spectrometry, also known as ICP-MS, is a non-destructive method for the estimation of elemental impurities. The test sample was prepared with microwave assisted acid digestion and introduced into optimized instrumental parameters for use of a quadrupole based Agilent 7700 inductively coupled plasma mass spectrometry instrument. The developed method was validated in terms of specificity, linearity, accuracy, and precision, limit of detection and limit of quantitation. The results for recoveries of all elements were found between 70 to 150 %. Calibration plots were linear. The low relative standard deviation values and high recoveries of the method confirm the suitability of the method.


Keywords

Bilastine, Inductively Plasma Mass Spectrometry, Linearitty, Accuracy, Precision, ICP-MS.