High-performance liquid chromatography method for the quantification of duloxetine in rat plasma

S. Lakshmana Prabu, S. Shahnawaz, A. Karthik, C. Dinesh Kumar, S.G. Vasantharaju

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

A sensitive and selective HPLC method was developed for quantification of duloxetine, in rat plasma. Trifluoperazine was used as an internal standard (IS). The present method used protein precipitation for extraction of the drug from rat plasma. Separation and quantification was carried using in isocratic mode using 25 mM phosphate buffer (pH 3.0)/acetonitrile (60:40, % v/v) as mobile phase and on reverse-phase C18 phenyl column (250 mm x 4.6 mm, 5μ) and the column effluent was monitored by UV detector at 217 nm. This method was linear over the range of 44 - 2816.00 ng/ml with regression coefficient greater than 0.99. The mean recovery of duloxetine and IS were 82.33 ± 2.10 and 75.37 ± 1.07, respectively and the method was found to be precise, accurate and specific during the study. This validated method is sensitive and reproducible and it can be used for pharmacokinetic studies.
Original languageEnglish
Pages (from-to)283-292
Number of pages10
JournalArs Pharmaceutica
Volume49
Issue number4
Publication statusPublished - 2008

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High Pressure Liquid Chromatography
Trifluoperazine
Buffers
Pharmacokinetics
Phosphates
Duloxetine Hydrochloride
High-performance Liquid Chromatography
Quantification
Rat
Plasma
Pharmaceutical Preparations
Proteins

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Lakshmana Prabu, S., Shahnawaz, S., Karthik, A., Dinesh Kumar, C., & Vasantharaju, S. G. (2008). High-performance liquid chromatography method for the quantification of duloxetine in rat plasma. Ars Pharmaceutica, 49(4), 283-292.
Lakshmana Prabu, S. ; Shahnawaz, S. ; Karthik, A. ; Dinesh Kumar, C. ; Vasantharaju, S.G. / High-performance liquid chromatography method for the quantification of duloxetine in rat plasma. In: Ars Pharmaceutica. 2008 ; Vol. 49, No. 4. pp. 283-292.
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abstract = "A sensitive and selective HPLC method was developed for quantification of duloxetine, in rat plasma. Trifluoperazine was used as an internal standard (IS). The present method used protein precipitation for extraction of the drug from rat plasma. Separation and quantification was carried using in isocratic mode using 25 mM phosphate buffer (pH 3.0)/acetonitrile (60:40, {\%} v/v) as mobile phase and on reverse-phase C18 phenyl column (250 mm x 4.6 mm, 5μ) and the column effluent was monitored by UV detector at 217 nm. This method was linear over the range of 44 - 2816.00 ng/ml with regression coefficient greater than 0.99. The mean recovery of duloxetine and IS were 82.33 ± 2.10 and 75.37 ± 1.07, respectively and the method was found to be precise, accurate and specific during the study. This validated method is sensitive and reproducible and it can be used for pharmacokinetic studies.",
author = "{Lakshmana Prabu}, S. and S. Shahnawaz and A. Karthik and {Dinesh Kumar}, C. and S.G. Vasantharaju",
note = "Cited By :2 Export Date: 10 November 2017 Correspondence Address: Lakshmana Prabu, S.; Manipal College of Pharmaceutical Sciences, Manipal - 576 104. Karnataka, India; email: slaxmanvel@gmail.com Chemicals/CAS: duloxetine, 116539-59-4, 136434-34-9; trifluoperazine, 117-89-5, 440-17-5 Manufacturers: Zydus Cadila, India References: Anderson, D., Reed, S., Lintemoot, J., Kegler, S., Dequintana, S., Sandberg, M., Muto, J., A first look at duloxetine (Cymbalta) in a postmortem laboratory (2006) Journal of Analytical Toxicology, 30 (8), pp. 576-580. , http://docstore.ingenta.com/cgi-bin/ds_deliver/1/u/d/ISIS/32505901.1/ pres/jat/2006/00000030/00000008/art00015/ 42E29213E3CA8E74116114223589CE08A28E30F276.pdf?link=http://www.ingentaconnect. com/error/delivery&format=pdf; Brunton, L.L., Parker, K.S., Lazo, J.S., (2005) The Pharmacological Basis of Therapeutics, 11, pp. 436-450. , Goodman and Gillman's, McGraw Hill Publishing, London; Mercolini, L., Mandrioli, R., Cazzolla, R., Amore, M., Raggi, M.A., HPLC analysis of the novel antidepressant duloxetine in human plasma after an original solid-phase extraction procedure (2007) Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 856 (1-2), pp. 81-87. , DOI 10.1016/j.jchromb.2007.05.031, PII S1570023207003923; Ma, N., Zhang, B.-K., Li, H.-D., Chen, B.-M., Xu, P., Wang, F., Zhu, R.-H., Zhu, Y.-G., Determination of duloxetine in human plasma via LC/MS and subsequent application to a pharmacokinetic study in healthy Chinese volunteers (2007) Clinica Chimica Acta, 380 (1-2), pp. 100-105. , DOI 10.1016/j.cca.2007.01.018, PII S0009898107000277; Lobo, E.D., Loghin, C., Knadler, M.P., Quinlan, T., Zhang, L., Chappell, J., Pharmacokinetics of duloxetine in breast milk and plasma of healthy postpartum women (2008) Clin Pharmacokinet, 47, pp. 103-109; Soni, P., Mariappan, T.T., Banerjee, U.C., High-performance liquid chromatographic method for the simultaneous estimation of the key intermediates of duloxetine (2005) Talanta, 67 (5), pp. 975-978. , DOI 10.1016/j.talanta.2005.04.020, PII S0039914005002055; Satonin, D.K., McCulloch, J.D., Kuo, F., Knadler, M.P., Development and validation of a liquid chromatography-tandem mass spectrometric method for the determination of the major metabolites of duloxetine in human plasma (2007) Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 852 (1-2), pp. 582-589. , DOI 10.1016/j.jchromb.2007.02.025, PII S157002320700150X; Schultz, M.M., Furlong, E.T., Trace Analysis of Antidepressant Pharmaceuticals and Their Select Degradates in Aquatic Matrixes by LC/ESI/MS/MS (2008) Anal Chem, 80, pp. 1756-1762; Senthamil Selvan, P., Gowda, K.V., Mandal, U., Sam Solomon, W.D., Pal, T.K., Determination of duloxetine in human plasma by liquid chromatography with atmospheric pressure ionization-tandem mass spectrometry and its application to pharmacokinetic study (2007) Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 858 (1-2), pp. 269-275. , DOI 10.1016/j.jchromb.2007.09.002, PII S1570023207006423; Silva, B.J., Lancas, F.M., Queiroz, M.E., In-tube solid-phase microextraction coupled to liquid chromatography (in-tube SPME/LC) analysis of nontricyclic antidepressants in human plasma (2008) J Chromatogr B Analyt Technol Biomed Life Sci, 862, pp. 181-188; Sweetman, S.C., (2005) Martindale, The Complete Drug Reference, 34th Edn., 291. , Pharmaceutical Press, Great Britain; Waldschmitt, C., Vogel, F., Maurer, C., Hiemke, C., Measurement of duloxetine in blood using high-performance liquid chromatography with spectrophotometric detection and column switching (2007) Therapeutic Drug Monitoring, 29 (6), pp. 767-772. , DOI 10.1097/FTD.0b013e31815d0dfa, PII 0000769120071200000008",
year = "2008",
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pages = "283--292",
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}

Lakshmana Prabu, S, Shahnawaz, S, Karthik, A, Dinesh Kumar, C & Vasantharaju, SG 2008, 'High-performance liquid chromatography method for the quantification of duloxetine in rat plasma', Ars Pharmaceutica, vol. 49, no. 4, pp. 283-292.

High-performance liquid chromatography method for the quantification of duloxetine in rat plasma. / Lakshmana Prabu, S.; Shahnawaz, S.; Karthik, A.; Dinesh Kumar, C.; Vasantharaju, S.G.

In: Ars Pharmaceutica, Vol. 49, No. 4, 2008, p. 283-292.

Research output: Contribution to journalArticle

TY - JOUR

T1 - High-performance liquid chromatography method for the quantification of duloxetine in rat plasma

AU - Lakshmana Prabu, S.

AU - Shahnawaz, S.

AU - Karthik, A.

AU - Dinesh Kumar, C.

AU - Vasantharaju, S.G.

N1 - Cited By :2 Export Date: 10 November 2017 Correspondence Address: Lakshmana Prabu, S.; Manipal College of Pharmaceutical Sciences, Manipal - 576 104. Karnataka, India; email: slaxmanvel@gmail.com Chemicals/CAS: duloxetine, 116539-59-4, 136434-34-9; trifluoperazine, 117-89-5, 440-17-5 Manufacturers: Zydus Cadila, India References: Anderson, D., Reed, S., Lintemoot, J., Kegler, S., Dequintana, S., Sandberg, M., Muto, J., A first look at duloxetine (Cymbalta) in a postmortem laboratory (2006) Journal of Analytical Toxicology, 30 (8), pp. 576-580. , http://docstore.ingenta.com/cgi-bin/ds_deliver/1/u/d/ISIS/32505901.1/ pres/jat/2006/00000030/00000008/art00015/ 42E29213E3CA8E74116114223589CE08A28E30F276.pdf?link=http://www.ingentaconnect. com/error/delivery&format=pdf; Brunton, L.L., Parker, K.S., Lazo, J.S., (2005) The Pharmacological Basis of Therapeutics, 11, pp. 436-450. , Goodman and Gillman's, McGraw Hill Publishing, London; Mercolini, L., Mandrioli, R., Cazzolla, R., Amore, M., Raggi, M.A., HPLC analysis of the novel antidepressant duloxetine in human plasma after an original solid-phase extraction procedure (2007) Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 856 (1-2), pp. 81-87. , DOI 10.1016/j.jchromb.2007.05.031, PII S1570023207003923; Ma, N., Zhang, B.-K., Li, H.-D., Chen, B.-M., Xu, P., Wang, F., Zhu, R.-H., Zhu, Y.-G., Determination of duloxetine in human plasma via LC/MS and subsequent application to a pharmacokinetic study in healthy Chinese volunteers (2007) Clinica Chimica Acta, 380 (1-2), pp. 100-105. , DOI 10.1016/j.cca.2007.01.018, PII S0009898107000277; Lobo, E.D., Loghin, C., Knadler, M.P., Quinlan, T., Zhang, L., Chappell, J., Pharmacokinetics of duloxetine in breast milk and plasma of healthy postpartum women (2008) Clin Pharmacokinet, 47, pp. 103-109; Soni, P., Mariappan, T.T., Banerjee, U.C., High-performance liquid chromatographic method for the simultaneous estimation of the key intermediates of duloxetine (2005) Talanta, 67 (5), pp. 975-978. , DOI 10.1016/j.talanta.2005.04.020, PII S0039914005002055; Satonin, D.K., McCulloch, J.D., Kuo, F., Knadler, M.P., Development and validation of a liquid chromatography-tandem mass spectrometric method for the determination of the major metabolites of duloxetine in human plasma (2007) Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 852 (1-2), pp. 582-589. , DOI 10.1016/j.jchromb.2007.02.025, PII S157002320700150X; Schultz, M.M., Furlong, E.T., Trace Analysis of Antidepressant Pharmaceuticals and Their Select Degradates in Aquatic Matrixes by LC/ESI/MS/MS (2008) Anal Chem, 80, pp. 1756-1762; Senthamil Selvan, P., Gowda, K.V., Mandal, U., Sam Solomon, W.D., Pal, T.K., Determination of duloxetine in human plasma by liquid chromatography with atmospheric pressure ionization-tandem mass spectrometry and its application to pharmacokinetic study (2007) Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences, 858 (1-2), pp. 269-275. , DOI 10.1016/j.jchromb.2007.09.002, PII S1570023207006423; Silva, B.J., Lancas, F.M., Queiroz, M.E., In-tube solid-phase microextraction coupled to liquid chromatography (in-tube SPME/LC) analysis of nontricyclic antidepressants in human plasma (2008) J Chromatogr B Analyt Technol Biomed Life Sci, 862, pp. 181-188; Sweetman, S.C., (2005) Martindale, The Complete Drug Reference, 34th Edn., 291. , Pharmaceutical Press, Great Britain; Waldschmitt, C., Vogel, F., Maurer, C., Hiemke, C., Measurement of duloxetine in blood using high-performance liquid chromatography with spectrophotometric detection and column switching (2007) Therapeutic Drug Monitoring, 29 (6), pp. 767-772. , DOI 10.1097/FTD.0b013e31815d0dfa, PII 0000769120071200000008

PY - 2008

Y1 - 2008

N2 - A sensitive and selective HPLC method was developed for quantification of duloxetine, in rat plasma. Trifluoperazine was used as an internal standard (IS). The present method used protein precipitation for extraction of the drug from rat plasma. Separation and quantification was carried using in isocratic mode using 25 mM phosphate buffer (pH 3.0)/acetonitrile (60:40, % v/v) as mobile phase and on reverse-phase C18 phenyl column (250 mm x 4.6 mm, 5μ) and the column effluent was monitored by UV detector at 217 nm. This method was linear over the range of 44 - 2816.00 ng/ml with regression coefficient greater than 0.99. The mean recovery of duloxetine and IS were 82.33 ± 2.10 and 75.37 ± 1.07, respectively and the method was found to be precise, accurate and specific during the study. This validated method is sensitive and reproducible and it can be used for pharmacokinetic studies.

AB - A sensitive and selective HPLC method was developed for quantification of duloxetine, in rat plasma. Trifluoperazine was used as an internal standard (IS). The present method used protein precipitation for extraction of the drug from rat plasma. Separation and quantification was carried using in isocratic mode using 25 mM phosphate buffer (pH 3.0)/acetonitrile (60:40, % v/v) as mobile phase and on reverse-phase C18 phenyl column (250 mm x 4.6 mm, 5μ) and the column effluent was monitored by UV detector at 217 nm. This method was linear over the range of 44 - 2816.00 ng/ml with regression coefficient greater than 0.99. The mean recovery of duloxetine and IS were 82.33 ± 2.10 and 75.37 ± 1.07, respectively and the method was found to be precise, accurate and specific during the study. This validated method is sensitive and reproducible and it can be used for pharmacokinetic studies.

M3 - Article

VL - 49

SP - 283

EP - 292

JO - Ars Pharmaceutica

JF - Ars Pharmaceutica

SN - 0004-2927

IS - 4

ER -