RAPID, HIGHLY EFFICIENT AND STABILITY INDICATING RP-UPLC METHOD FOR THE QUANTITATIVE DETERMINATION OF POTENTIAL IMPURITIES OF CARVEDILOL ACTIVE PHARMACEUTICAL INGREDIENT
Keywords:
Carvedilol, Impurities, RP-UPLC, Validation, Forced degradationAbstract
Objective: The main objective of the proposed study was to develop a sensitive, rapid and stability indicating reverse phase UV-UPLC method for the quantitative determination of potential impurities in carvedilol.
Methods: The chromatographic separations were achieved on waters Acquity UPLC BEH C18 column (100 mm length 2.1 mm ID with 1.7 µm particle size, Waters corporation, MA, USA). Mobile phase A consisted, 0.04% trifluroacetic acid in water and mobile phase B consisted as 0.04% trifluroacetic acid in acetonitrile with a gradient programme (Tmin A:B) T090:10, T465:35, T740:60, T1020:80, T10.1 90:10. The column temperature was maintained at 60 °C and the detection was carried out at 240 nm. The flow rate was set to 0.5 mL/min.
Results: Efficient chromatographic separation was achieved on UPLC BEH C18 stationary phase in gradient mode using simple mobile phase. In forced degradation study, major degradation of the drug substance was found to occur under oxidative stress conditions to form carvedilol hydroxylamine. The method was validated according to ICH guidelines with respect to specificity, precision, linearity and accuracy. Regression analysis showed the correlation coefficient value greater than 0.999 for carvedilol and its five impurities. Detection limit of impurities was in the range of 0.002–0.004% indicating the high sensitivity of the newly developed method. Accuracy of the method was established based on the recovery obtained between 96.7% and 108.1% for all impurities.
Conclusion: A new, rapid and highly efficient UPLC method was developed, which separates all impurities and degradation products of carvedilol. The method has been validated in order to ascertain the suitability and stability indicating power of the method.
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