Volume 8, Issue 4, October 2018
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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.
PAGES: 56-67 | 28 VIEWS 35 DOWNLOADS
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; 8(4): 56-67.