A validated UPLC method for the determination of process- related impurities in Antimigraine bulk drug

An UPLC method has been developed and subsequently validated for the determination of antimigraine drug and its process-related impurities. Separation was achieved with Halo C18, 50x 4.6 mm, 2.7μm column and 1.36 g ofmonobasic potassium phosphate in 1000 mL of water with 2 mL of triethylamine at pH 6.8 using H3PO4, acetonitrile and methanol in the ratio of 55 : 38 : 7 as eluent in isocratic mode. Flow rate was set as 1 mL.minUV detection was performed at 225 nm. The method was validated with respect to specificity, accuracy, precision, linearity, robustness, limit of quantification and limit of detection. The accuracy of the method demonstrated at three levels in the range of 50-150% of the specification limit and the recovery of impurities were found to be in range of 98 to 102%. The detection limits of the process related impurities ranged between 0.16 and 0.24 μgmL. The described method is simple, rapid, linear, precise, accurate, robust and stability indicating. The method is useful during process development and quality of bulk manufacturing.