Tropical Journal of Pharmaceutical Research

Original Research Article | OPEN ACCESS

Determination of Tolterodine Tartrate in Bulk and Formulation by Extractive Colorimetric Method using Tropaeolin OOO-1

Mani Ganesh¹, Pushparaj Hemalatha¹, Mei Mei Peng¹, Rajangam Vinodh¹, Kalaimani Saktimanigandan², Hyun Tae Jang¹

¹Department of Chemical Engineering, Hanseo University, 360 Daegok-ri, Haemi-myun, Season -356-706, Chungcheongnam-do, South Korea; ²Alkem Lab Ltd, C-17/7, MIDC Industrial Area, Taloja-410208, Raigad District, Navi Mumbai, Maharashtra, India.

For correspondence:- Hyun Jang Email: htjang@hanseo.ac.kr Tel:+82416601423

Received: 9 September 2013 Accepted: 28 August 2014 Published: 19 October 2014

Citation: Ganesh M, Hemalatha P, Peng MM, Vinodh R, Saktimanigandan K, Jang HT. Determination of Tolterodine Tartrate in Bulk and Formulation by Extractive Colorimetric Method using Tropaeolin OOO-1. Trop J Pharm Res 2014; 13(10):1667-1673 doi: 10.4314/tjpr.v13i10.14

© 2014 The authors.
This is an Open Access article that uses a funding model which does not charge readers or their institutions for access and distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0) and the Budapest Open Access Initiative (http://www.budapestopenaccessinitiative.org/read), which permit unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited..

Abstract

Purpose: To develop a new simple, accurate, precise and fully validated extractive colorimetric method for the determination of tolterodine tartrate (TL) in bulk and in tablet dosage form,

Method: A chloroform extractable orange red complex formed between the acid dye, tropaeolin OOO-1 and tolterodine in acid media is the basis for this method. The maximum wavelength of absorbance of the complex was 503 nm. The validation parameters such as stability, accuracy, precision, robustness and ruggedness were evaluated according to International conference on harmonization (ICH) and United States Pharmacopoeia (USP) guidelines.

Results: The absorbance of the complex obeyed Beer law over the range 1 - 30 µg/mL with a correlation coefficient of 0.9945, with a molar absorptivity and Sandal’s sensitivity of 0.0398 and 1.1954 x 10⁴, respectively. The lower limit of detection (LOD) and of quantification (LOQ) of the method were 0.08 and 1 μg mL^-1, respectively.

Conclusion: The developed method is validated and has high recovery and precision, and thus is suitable for routine analysis of the drug in bulk and formulations.

Keywords: Tolterodine, Tropaeolin, Extractive colorimetry, Validation, Solid dosage