STABILITY INDICATING RP-UPLC METHOD DEVELOPMENT FOR RELATED SUBSTANCES OF ANTI-EMETIC TRIMETHOBENZAMIDE HYDROCHLORIDE, ITS VALIDATION AND MASS BALANCE STUDY
Author(s): Vitthal. M. Dhalape, Santosh.T. Khadangale and Rahul.V. Pinjari*
Abstract: A simple and rapid reverse phase ultra-performance liquid chromatographic (RP-UPLC) method for determination of related substances of an antiemetic drug Trimethobenzamide Hydrochloride (TMB·HCI) is reported. The RPUPLC method is developed and validated as per the International Council for Harmonisation (ICH) guidelines Q2(R1). The effective chromatographic separations were achieved on Acquity CSH Phenyl-Hexyl, 2.1 x 100 mm 1.7µm column and reverse phase with linear gradient elution. The mobile phase-A is 0.1% Nonaflurobutane -1 sulfonic acid in water, while mixture of 35:65 ratio of 0.1 % Nonaflurobutane-1-sulphonic acid in purified water to acetonitrile is mobile phase-B. The flow rate of 0.4 mL min−1 and PDA/UV detector are used. The method is linear in the range of limit of quantitation (LOQ) to 150 % level with respect to specification concentration limit of impurities. The correlation coefficient of all impurities and TMB is greater than 0.999. The LOQ of all known impurities and TMB is in between 10 to 30% of its specification limits. The relative response factor are calculated to all eigth known impurites. The unknown peaks are well separate, observed results are comparable to initial values. This RP-UPLC method is accurate, precise and robust. The forced degrdiation study of the TMB·HCI has been carried out and the mass balance is proven.
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How To Cite this Article:
Vitthal. M. Dhalape, Santosh.T. Khadangale and Rahul.V. Pinjari*. STABILITY INDICATING RP-UPLC METHOD DEVELOPMENT FOR RELATED SUBSTANCES OF ANTI-EMETIC TRIMETHOBENZAMIDE HYDROCHLORIDE, ITS VALIDATION AND MASS BALANCE STUDY. 2018; : 56-67.