Abstract

The present work takes into account the development of RP-HPLC for simultaneous method estimation and validation of pyrimethamine and sulfamethoxypyrazine in pharmaceutical formulation. The chromatographic separation was accomplished on C8 column by using acetonitrile and potassium dihydrogen phosphate as the mobile phase (60:40 v/v) having a flow rate of 0.8 mL/min. The eluent was detected at 254nm, simultaneously for both the drugs. The retention time for pyrimethamine and sulfamethoxypyrazine was found to be 3.33 min and 4.21 min respectively. According to the ICH guidelines the develop method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantitation, robustness and stress degradation studies. This validated method can be suggested for the routine simultaneous laboratory analysis of pyrimethamine and sulfamethoxypyrazine.

Key words: Pyrimethamine (PYR), Sulfamethoxypyrazine (SLP), RP-HPLC, ICH guidelines