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Original Research Article
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
and 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:
Email:
htjang@hanseo.ac.kr; Tel:
+82-41-660-1423
Received: 9 September 2013
Revised accepted: 28 August
2014
Tropical
Journal of Pharmaceutical Research, October 2014;
13(10): 1667-1673
http://dx.doi.org/10.4314/tjpr.v13i10.14
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 |
