A novel stability indicating method development and validation for the quantification of related substances in pyrimethamine tablet dosage form by RP-HPLC

Authors

  • Kannan Jakkan Department of Chemistry, Jaipur National University, Rajashthan. India
  • Nataraj palaniyappan Novitium Pharma LLC, New jersey, USA.
  • Ravisankar Mathesan Vinayaka missions Research foundation, Salem, Tamilnadu, India.

DOI:

https://doi.org/10.61096/ijpar.v9.iss3.2020.172-183

Keywords:

RP- HPLC, Related substance, Pyrimethamine, Method development, Method Validation

Abstract

A new stability indicating RP-HPLC method was developed to analyse the related substances in Pyrimethamine tablets. The projected method shows with accurate, precise, linear, robust and rugged. The developed method validated as per ICH guidelines by using high performance liquid chromatography.  Column configuration - Agilent zorbax SB-C8, 150 x 4.6 mm 3.5μm column. Mobile phase contains buffer pH 4.0: methanol in the ratio of 55:45 %v/v with the flow rate of 1.2 ml/min. Detection fixed at 280 nm. The retention time of the pyrimethamine is 5.007 min. Runtime 12 minutes for standard  and  40  minutes  for  blank  and  sample.  The  validation  parameters  such  as  precision,  accuracy,  linearity, robustness, ruggedness, forced degradation study and filter study were evaluated. Linearity range covered from LOQ level. Correlation coefficient square found not less than 0.98.Recovery % occurs between 99%  to 102 % for impurities

Downloads

Published

2020-08-14

How to Cite

Kannan Jakkan, Nataraj palaniyappan, & Ravisankar Mathesan. (2020). A novel stability indicating method development and validation for the quantification of related substances in pyrimethamine tablet dosage form by RP-HPLC. IJPAR JOURNAL, 9(3), 172–183. https://doi.org/10.61096/ijpar.v9.iss3.2020.172-183

Issue

Vol. 9 No. 3 (2020): 2020 Volume - 9 Issue - 3

Section

Articles