Compendial invitro - Method validation for pyrimethamine tablet dosage form by UV spectrophotometric method
DOI:
https://doi.org/10.61096/ijpar.v9.iss3.2020.167-171Keywords:
Pyrimethamine, Dissolution, Method validation, Method verification, UV spectrophotometryAbstract
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