Determination of Tolterodine tartrate in bulk and formulation by extractive colorimetric method using Tropaeolin OOO-1
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
Submission of a manuscript to this journal is a representation that the manuscript has not been published previously and is not under consideration for publication elsewhere.
All authors named in each manuscript would be required to sign a form (to be supplied by the Editor) so that they may retain their copyright in the article but to assign to us (the Publishers) and its licensees in perpetuity, in all forms, formats and media (whether known or created in the future) to (i) publish, reproduce, distribute, display and store the contribution, (ii) translate the contribution into other languages, create adaptations, reprints, include within collections and create summaries, extracts and/or abstracts of the contribution, (iii) create any other derivative works(s) based on the contribution, (iv) to exploit all subsidiary rights in the contribution, (v) the inclusion of electronic links from the contribution to third party material where-ever it may be located, and (vi) license any thrid party to do any or all of the above.