Reverse-phase, high performance liquid chromatographic method for the determination of tolterodine tartrate in routine quality control samples

V.S.N. Murthy Dwibhashyam, P. Keerthi, J. Vijaya Ratna, A.N. Nagappa

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

A selective, sensitive, and rugged reverse phase-high performance liquid chromatographic method has been developed for the determination of tolterodine tartrate in routine quality control samples. The mobile phase consisted of acetonitrile:phosphate buffer (pH 7.0) in 55:45 v/v ratio. The mobile phase was also used for the extraction of tolterodine tartrate from its formulations. The chromatography was carried out on a Luna 100A, C-18 (5-μ, 250 X 4.60 mm) column. The software used in the chromatographic analysis was Empower Photodiode Array (PDA) software (Waters,™ Milford, CT). The UV spectrophotometric determination was done at 210 nm. Retention time was found to be about 7.0 ± 0.5 min. The standard curve was linear (r2 = 0.9997) over the concentration range of 0.1-0.3 mg/mL. The method was found to be accurate, precise, specific, and rugged. The limit of detection was 0.16 μg/mL and the limit of quantification was 0.489 μg/mL. With a short chromatographic run time, the proposed method can be used for the estimation of large number of quality control samples in a short period. ©PDA, Inc. 2009.
Original languageEnglish
Pages (from-to)234-239
Number of pages6
JournalPDA Journal of Pharmaceutical Science and Technology
Volume63
Issue number3
Publication statusPublished - 2009

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Quality Control
Chromatography
Software
Limit of Detection
Buffers
Phosphates
Water
Tolterodine Tartrate
acetonitrile

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title = "Reverse-phase, high performance liquid chromatographic method for the determination of tolterodine tartrate in routine quality control samples",
abstract = "A selective, sensitive, and rugged reverse phase-high performance liquid chromatographic method has been developed for the determination of tolterodine tartrate in routine quality control samples. The mobile phase consisted of acetonitrile:phosphate buffer (pH 7.0) in 55:45 v/v ratio. The mobile phase was also used for the extraction of tolterodine tartrate from its formulations. The chromatography was carried out on a Luna 100A, C-18 (5-μ, 250 X 4.60 mm) column. The software used in the chromatographic analysis was Empower Photodiode Array (PDA) software (Waters,™ Milford, CT). The UV spectrophotometric determination was done at 210 nm. Retention time was found to be about 7.0 ± 0.5 min. The standard curve was linear (r2 = 0.9997) over the concentration range of 0.1-0.3 mg/mL. The method was found to be accurate, precise, specific, and rugged. The limit of detection was 0.16 μg/mL and the limit of quantification was 0.489 μg/mL. With a short chromatographic run time, the proposed method can be used for the estimation of large number of quality control samples in a short period. {\circledC}PDA, Inc. 2009.",
author = "{Murthy Dwibhashyam}, V.S.N. and P. Keerthi and {Vijaya Ratna}, J. and A.N. Nagappa",
note = "Cited By :17 Export Date: 10 November 2017 CODEN: JPHTE Correspondence Address: Nagappa, A. N.; Pharma Management Department, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal - 576 104, Karnataka, India; email: anantha1232000@gmail.com Chemicals/CAS: acetonitrile, 75-05-8; phosphate, 14066-19-4, 14265-44-2; tolterodine, 124937-51-5; Benzhydryl Compounds; Cresols; Muscarinic Antagonists; Phenylpropanolamine, 14838-15-4; tolterodine, 124937-51-5 Manufacturers: Fleming, India References: Nilvebrant, L., Hallen, B., Larsson, G., Tolterodine - A new bladder selective muscarinic receptor antagonist: Preclinical pharmacological and clinical data (1997) Life Sci., 60 (13-14), pp. 1129-1136; Nilvebrant, L., Clinical experiences with tolterodine (2001) Life Sci., 68 (22-23), pp. 2549-2556; Olsson, B., Szamosi, J., Multiple dose pharmacokinetics of a new once daily extended release tolterodine formulation versus immediate release tolterodine (2001) Clin. Pharmacokinet., 40 (3), pp. 227-235; Kumar, Y.R., Ramulu, G., Vevakanand, V.V., Vaidyanathan, G., Srinivas, K., Kumar, M.K., Mukkanti, K., Suryanarayana, M.V., A validated chiral HPLC method for the enantiomeric separation of tolterodine tartarate (2004) J. Pharm. Biomed. Anal., 35 (5), pp. 1279-1285; Palmer, L., Andersson, L., Andersson, T., Stendberg, U., Determination of tolterodine and the 5-hydroxymethyl metabolite in plasma, serum and urine using gas chromatography-mass spectrometry (1997) J. Pharm. Biomed. Anal., 16 (1), pp. 155-165; Swart, R., Koivisto, P., Markides, K.E., Column switching in capillary liquid chromatography-tandem mass spectrometry for the quantitation of pg/ml concentrations of the free basic drug tolterodine and its active 5-hydroxymethyl metabolite in microliter volumes of plasma (1998) J. Chromatogr., A, 828 (1-2), pp. 209-218; Swart, R., Koivisto, P., Markides, K.E., Capillary solid-phase extraction-tandem mass spectrometry for fast quantification of free concentrations of tolterodine and two metabolites in ultra filtered plasma samples (1999) J. Chromatogr., B Biomed. Sci. Appl., 736 (1-2), pp. 247-253",
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pages = "234--239",
journal = "PDA Journal of Pharmaceutical Science and Technology",
issn = "1079-7440",
publisher = "Parenteral Drug Association Inc.",
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Reverse-phase, high performance liquid chromatographic method for the determination of tolterodine tartrate in routine quality control samples. / Murthy Dwibhashyam, V.S.N.; Keerthi, P.; Vijaya Ratna, J.; Nagappa, A.N.

In: PDA Journal of Pharmaceutical Science and Technology, Vol. 63, No. 3, 2009, p. 234-239.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Reverse-phase, high performance liquid chromatographic method for the determination of tolterodine tartrate in routine quality control samples

AU - Murthy Dwibhashyam, V.S.N.

AU - Keerthi, P.

AU - Vijaya Ratna, J.

AU - Nagappa, A.N.

N1 - Cited By :17 Export Date: 10 November 2017 CODEN: JPHTE Correspondence Address: Nagappa, A. N.; Pharma Management Department, Manipal College of Pharmaceutical Sciences, Manipal University, Manipal - 576 104, Karnataka, India; email: anantha1232000@gmail.com Chemicals/CAS: acetonitrile, 75-05-8; phosphate, 14066-19-4, 14265-44-2; tolterodine, 124937-51-5; Benzhydryl Compounds; Cresols; Muscarinic Antagonists; Phenylpropanolamine, 14838-15-4; tolterodine, 124937-51-5 Manufacturers: Fleming, India References: Nilvebrant, L., Hallen, B., Larsson, G., Tolterodine - A new bladder selective muscarinic receptor antagonist: Preclinical pharmacological and clinical data (1997) Life Sci., 60 (13-14), pp. 1129-1136; Nilvebrant, L., Clinical experiences with tolterodine (2001) Life Sci., 68 (22-23), pp. 2549-2556; Olsson, B., Szamosi, J., Multiple dose pharmacokinetics of a new once daily extended release tolterodine formulation versus immediate release tolterodine (2001) Clin. Pharmacokinet., 40 (3), pp. 227-235; Kumar, Y.R., Ramulu, G., Vevakanand, V.V., Vaidyanathan, G., Srinivas, K., Kumar, M.K., Mukkanti, K., Suryanarayana, M.V., A validated chiral HPLC method for the enantiomeric separation of tolterodine tartarate (2004) J. Pharm. Biomed. Anal., 35 (5), pp. 1279-1285; Palmer, L., Andersson, L., Andersson, T., Stendberg, U., Determination of tolterodine and the 5-hydroxymethyl metabolite in plasma, serum and urine using gas chromatography-mass spectrometry (1997) J. Pharm. Biomed. Anal., 16 (1), pp. 155-165; Swart, R., Koivisto, P., Markides, K.E., Column switching in capillary liquid chromatography-tandem mass spectrometry for the quantitation of pg/ml concentrations of the free basic drug tolterodine and its active 5-hydroxymethyl metabolite in microliter volumes of plasma (1998) J. Chromatogr., A, 828 (1-2), pp. 209-218; Swart, R., Koivisto, P., Markides, K.E., Capillary solid-phase extraction-tandem mass spectrometry for fast quantification of free concentrations of tolterodine and two metabolites in ultra filtered plasma samples (1999) J. Chromatogr., B Biomed. Sci. Appl., 736 (1-2), pp. 247-253

PY - 2009

Y1 - 2009

N2 - A selective, sensitive, and rugged reverse phase-high performance liquid chromatographic method has been developed for the determination of tolterodine tartrate in routine quality control samples. The mobile phase consisted of acetonitrile:phosphate buffer (pH 7.0) in 55:45 v/v ratio. The mobile phase was also used for the extraction of tolterodine tartrate from its formulations. The chromatography was carried out on a Luna 100A, C-18 (5-μ, 250 X 4.60 mm) column. The software used in the chromatographic analysis was Empower Photodiode Array (PDA) software (Waters,™ Milford, CT). The UV spectrophotometric determination was done at 210 nm. Retention time was found to be about 7.0 ± 0.5 min. The standard curve was linear (r2 = 0.9997) over the concentration range of 0.1-0.3 mg/mL. The method was found to be accurate, precise, specific, and rugged. The limit of detection was 0.16 μg/mL and the limit of quantification was 0.489 μg/mL. With a short chromatographic run time, the proposed method can be used for the estimation of large number of quality control samples in a short period. ©PDA, Inc. 2009.

AB - A selective, sensitive, and rugged reverse phase-high performance liquid chromatographic method has been developed for the determination of tolterodine tartrate in routine quality control samples. The mobile phase consisted of acetonitrile:phosphate buffer (pH 7.0) in 55:45 v/v ratio. The mobile phase was also used for the extraction of tolterodine tartrate from its formulations. The chromatography was carried out on a Luna 100A, C-18 (5-μ, 250 X 4.60 mm) column. The software used in the chromatographic analysis was Empower Photodiode Array (PDA) software (Waters,™ Milford, CT). The UV spectrophotometric determination was done at 210 nm. Retention time was found to be about 7.0 ± 0.5 min. The standard curve was linear (r2 = 0.9997) over the concentration range of 0.1-0.3 mg/mL. The method was found to be accurate, precise, specific, and rugged. The limit of detection was 0.16 μg/mL and the limit of quantification was 0.489 μg/mL. With a short chromatographic run time, the proposed method can be used for the estimation of large number of quality control samples in a short period. ©PDA, Inc. 2009.

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JO - PDA Journal of Pharmaceutical Science and Technology

JF - PDA Journal of Pharmaceutical Science and Technology

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