A New Method for Determination of Tolterodine and its Related Impurities in Active Pharmaceutical Ingredient by HPLC

DOI:

https://doi.org/10.37285/ijpsn.2017.10.1.5

Authors

  • Tentu Nageswara Rao
  • Apparao Karri
  • Revathi Prathipati
  • Parvatamma Botsa

Abstract

Tolterodine is used to treat overactive bladder symptoms such as loss of bladder control (incontinence) or a frequent need to urinate. A simple and inexpensive method was developed with high performance liquid chromatography with PDA detection for determination of tolterodine and related impurities.  The chromatographic separations were achieved on (250 × 4.6 mm), 5.0 µm make: symmetry, C8 column employing methanol and 0.1% orthophosphoric acid in water, in the ratio of 90:10 as mobile phase with gradient programmed at flow rate 1.0 mL/min was chosen. Three impurities were eluted within 35 minutes. The column temperature was maintained at 35oC and a detector wavelength of 220 nm was employed. The method was successfully validated by establishing system suitability, specificity, linearity, accuracy, LOD and LOQ. The validated method is useful for tolterodine assay in pharmaceutical products. 

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Keywords:

HPLC, Method validation, Tolterodine, LOD, LOQ

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Published

2017-01-31

How to Cite

1.
Rao TN, Karri A, Prathipati R, Botsa P. A New Method for Determination of Tolterodine and its Related Impurities in Active Pharmaceutical Ingredient by HPLC. Scopus Indexed [Internet]. 2017 Jan. 31 [cited 2024 Nov. 19];10(1):3600-7. Available from: https://ijpsnonline.com/index.php/ijpsn/article/view/827

Issue

Vol. 10 No. 1 (2017): January-February 2017

Section

Research Articles
Crossref
Scopus
Google Scholar
Europe PMC

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