Development and validation of a stability indicating high performance liquid chromatography method for trimethobenzamide

Authors

  • Narayana Swamy National Institute of Pharmaceutical Education and Research, Department of Pharmaceutical Analysis
  • Venkata Krishna Reddy National Institute of Pharmaceutical Education and Research, Department of Pharmaceutical Analysis
  • Poonam Thorat National Institute of Pharmaceutical Education and Research, Department of Pharmaceutical Analysis
  • Pinaki Sengupta National Institute of Pharmaceutical Education and Research https://orcid.org/0000-0002-6914-7057

DOI:

https://doi.org/10.1590/s2175-97902019000318817

Keywords:

Trimethobenzamide, Stability indicating assay method, Method development and validation, RP-HPLC

Abstract

A simple, accurate, precise and robust stability indicating RP-HPLC assay method has been developed for the estimation of trimethobenzamide in stress sample. An isocratic separation of trimethobenzamide was achieved on Kromasil 100 C-18 column (250 X 4.6mm, 5μ) with a flow rate of 1.0 ml/min and by using a photodiode array detector to detect the analyte at 213nm. The optimized mobile phase consisted of methanol: ammonium formate (44:56, v/v). The drug was subjected to different forced degradation conditions according to ICH guidelines including acid, base, neutral hydrolysis, oxidation, photolysis and thermal degradation. Degradation products were found only in basic and oxidative degradation conditions. All the degradation products got eluted in an overall analytical run time of 12min. The developed analytical method has been validated according to the ICH guidelines. Response of trimethobenzamide was linear over the concentration range of 0.5-50μg/ mL (r2 = 0.999). Accuracy was found to be in between 94.03% to 100.39%. Degradation products resulting from the stress studies did not interfere with the detection of the analyte.

Downloads

Download data is not yet available.

Downloads

Published

2020-12-09

How to Cite

Swamy, N. ., Reddy, V. K. ., Thorat, P. ., & Sengupta , P. . (2020). Development and validation of a stability indicating high performance liquid chromatography method for trimethobenzamide . Brazilian Journal of Pharmaceutical Sciences, 56, e18817. https://doi.org/10.1590/s2175-97902019000318817

Issue

Section

Article