Evaluation of Tropaeolin 000-1 as a Colorimetric Reagent for Assay of Duloxetine and Escitalopram in Solid Dosage Form

  • Mani Ganesh
  • Abidov Sh Aziz
  • Mei Mei Peng
  • Ramaswamy Ravikumar
  • Kalaimani Sakthimanigandan
  • Seung Eun Cha
  • Hyun Tae Jang
Keywords: Duloxetine, Escitalopram, Tropaeolin 000-1, Extractive spectrophotometry, Validation

Abstract

Purpose: To explore the application of tropaeolin 000-1 reagent for the rapid, precise and accurate determination of duloxetine hydrochloride (DX) and escitalopram maleate (ECT).

Methods: Determination of DX and ECT was based on the formation of complexes between the dye, DX and ECT in 0.1 M HCl. The resulting chromogen showed a maximum wavelength of absorption at 502 and 503 nm for DX and ECT, respectively. This method was validated for analytical parameters such as linearity, precision, accuracy, robustness, and ruggedness according to the guidelines of International Conference on Harmonization (ICH) and United States Pharmacopoeia (USP).

Results: The absorbance of the each chromogen formed with DX and ECT was linear over the range of 4 - 30 and 2.5 - 27.5 μg mL-1 for DX and ECT, with 0.9968 and 0.9979 as the regression coefficient, respectively. The limits of detection (LOD) were 0.0045 and 0.0015 μg mL-1 for DX and ECT, respectively, with the limits of quantification (LOQ) at 0.5 and 0.08 μg mL-1. The recovery (accuracy) of the methods resulted in low RSD values of 0.856 – 0.983 % for DX and 0.765 – 0.987 % for ECT.

Conclusion: The developed method shows a high degree of accuracy and precision for the determination of DX and ECT. Thus, tropaeolin 000-1 reagent is versatile for determining the contents of DX and ECT in their formulations.

Keywords: Duloxetine, Escitalopram, Tropaeolin 000-1, Extractive spectrophotometry, Validation

Published
2016-04-08
Section
Articles

Journal Identifiers


eISSN: 1596-9827
print ISSN: 1596-5996