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Sci. Pharm. 2012, 80(1), 101-114; doi:10.3797/scipharm.1110-14

A New Rapid and Sensitive Stability-Indicating UPLC Assay Method for Tolterodine Tartrate: Application in Pharmaceuticals, Human Plasma and Urine Samples

1
Analytical Development Laboratory, GVK Biosciences Private Limited, No.28A, Street No.15, IDA, Nacharam, Hyderabad-500 076, India
2
Department of Organic Chemistry, Food, Drugs & Water, Andhra University, Visakhapatnam-530 003, India
*
Author to whom correspondence should be addressed.
Received: 20 October 2011 / Accepted: 5 December 2011 / Published: 5 December 2011
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Abstract

A new rapid, simple, sensitive, selective and accurate reversed-phase stability-indicating Ultra Performance Liquid Chromatography (RP-UPLC) technique was developed for the assay of Tolterodine Tartrate in pharmaceutical dosage form, human plasma and urine samples. The developed UPLC method is superior in technology to conventional HPLC with respect to speed, solvent consumption, resolution and cost of analysis. Chromatographic run time was 6 min in reversed-phase mode and ultraviolet detection was carried out at 220 nm for quantification. Efficient separation was achieved for all the degradants of Tolterodine Tartrate on BEH C18 sub-2-μm Acquity UPLC column using Trifluoroacetic acid and acetonitrile as organic solvent in a linear gradient program. The active pharmaceutical ingredient was extracted from tablet dosage form using a mixture of acetonitrile and water as diluent. The calibration graphs were linear and the method showed excellent recoveries for bulk and tablet dosage form. The test solution was found to be stable for 40 days when stored in the refrigerator between 2 and 8 °C. The developed UPLC method was validated and meets the requirements delineated by the International Conference on Harmonization (ICH) guidelines with respect to linearity, accuracy, precision, specificity and robustness. The intra-day and inter-day variation was found be less than 1%. The method was reproducible and selective for the estimation of Tolterodine Tartrate. Because the method could effectively separate the drug from its degradation products, it can be employed as a stability-indicating one.
Keywords: Column liquid chromatography; Ultra Performance Liquid Chromatography; UPLC; Tolterodine Tartrate; Validation and quantification Column liquid chromatography; Ultra Performance Liquid Chromatography; UPLC; Tolterodine Tartrate; Validation and quantification
This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. (CC BY 4.0).

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MDPI and ACS Style

YANAMANDRA, R.; VADLA, C.S.; PUPPALA, U.; PATRO, B.; MURTHY, Y.L.N.; RAMAIAH, P.A. A New Rapid and Sensitive Stability-Indicating UPLC Assay Method for Tolterodine Tartrate: Application in Pharmaceuticals, Human Plasma and Urine Samples. Sci. Pharm. 2012, 80, 101-114.

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