Compendial invitro - Method validation for pyrimethamine tablet dosage form by UV spectrophotometric method

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.iss3.2020.167-171

Keywords:

Pyrimethamine, Dissolution, Method validation, Method verification, UV spectrophotometry

Abstract

Dissolution testing has developed in the pharmaceutical sector as a crucial key to illustrate drug released from the dosage forms. Pyrimethamine tablets USP, 25mg prescribed for anti-parasitic and to treat the toxoplasmosis. It has dissolution method in official monograph. The aim of current study was to verify the compendial dissolution method to adapt as In- house  method.  Outcomes  from  the  dissolution  method  verification  show  that  the  method  is suitable  for  in  house laboratory.  In vitro dissolution tests were performed using official method conditions.  Filter compatibility  study was evaluated. The test conditions were 0.1N HCl (900 mL at 37 ± 0.5 °C) as dissolution medium, paddle method (USP-II), 50 rpm, and 45 minutes. Results were satisfactory. The UV spectroscopy method was used to record the absorbance. The method shows linearity (r2 = 0.99986) in the concentration  range of 50% to 150% of standard concentration.  The % recoveries were good, ranging from 99.70% to 102.50%. The validated dissolution test is acceptable for its purpose and it can be applied in in-house analysis

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Published

2020-08-14

How to Cite

Kannan Jakkan, Nataraj palaniyappan, & Ravisankar Mathesan. (2020). Compendial invitro - Method validation for pyrimethamine tablet dosage form by UV spectrophotometric method. IJPAR JOURNAL, 9(3), 167–171. https://doi.org/10.61096/ijpar.v9.iss3.2020.167-171