Journal : Acta Chromatographica
Article : Development and validation of a stability-indicating LC-UV method for rapid analysis of buspirone in pharmaceutical dosage forms

Authors :
Dejaegher, B.
Vrije Universiteit Brussel — VUB Analytical Chemistry and Pharmaceutical Technology (FABI), Pharmaceutical Institute Laarbeeklaan 103 1090 Brussels Belgium,
Vander Heyden, Y.
Vrije Universiteit Brussel — VUB Analytical Chemistry and Pharmaceutical Technology (FABI), Pharmaceutical Institute Laarbeeklaan 103 1090 Brussels Belgium, yvanvdh@vub.ac.be,
Durón, R. R.
Universidad Autónoma de Nuevo León Departamento de Química Analítica, Facultad de Medicina P.O. Box 2316 Sucursal Tecnológico 64841 Monterrey Nuevo León México,
Almaguer, L. C.
Universidad Autónoma de Nuevo León Departamento de Química Analítica, Facultad de Medicina P.O. Box 2316 Sucursal Tecnológico 64841 Monterrey Nuevo León México,
Garza-Juárez, A.
Universidad Autónoma de Nuevo León Departamento de Química Analítica, Facultad de Medicina P.O. Box 2316 Sucursal Tecnológico 64841 Monterrey Nuevo León México,
Salazar Cavazos, M. L.
Universidad Autónoma de Nuevo León Departamento de Química Analítica, Facultad de Medicina P.O. Box 2316 Sucursal Tecnológico 64841 Monterrey Nuevo León México,
Waksman de Torres, N.
Universidad Autónoma de Nuevo León Departamento de Química Analítica, Facultad de Medicina P.O. Box 2316 Sucursal Tecnológico 64841 Monterrey Nuevo León México, nwaksman@fm.uanl.mx,
Garza-Juárez, A.
UANL, México Department of Analytical Chemistry, Facultad de Medicina Maderoy Aguirre Pequeño Col. Mitras Centro C.P. 64460 Mty, N.L. México,
Waksman de Torres, N.
UANL, México Department of Analytical Chemistry, Facultad de Medicina Maderoy Aguirre Pequeño Col. Mitras Centro C.P. 64460 Mty, N.L. México,
Salazar Cavazos, M. L.
UANL, México Department of Analytical Chemistry, Facultad de Medicina Maderoy Aguirre Pequeño Col. Mitras Centro C.P. 64460 Mty, N.L. México, masalaz52@yahoo.com,
Durón, R. R.
UANL, México Department of Analytical Chemistry, Facultad de Medicina Maderoy Aguirre Pequeño Col. Mitras Centro C.P. 64460 Mty, N.L. México,
Briciu, R. D.
Babeş-Bolyai University Faculty of Chemistry and Chemical Engineering Arany Janos Str. No 11 RO-400028 Cluj Napoca Romania,
Kot-Wasik, A.
Gdańsk University of Technology Chemical Faculty Narutowicza Str. No 11/12 80-952 Gdańsk Poland,
Namieśnik, J.
Gdańsk University of Technology Chemical Faculty Narutowicza Str. No 11/12 80-952 Gdańsk Poland,
Sârbu, C.
Babeş-Bolyai University Faculty of Chemistry and Chemical Engineering Arany Janos Str. No 11 RO-400028 Cluj Napoca Romania, costelsrb@yahoo.co.uk,
Sławik, T.
Medical University of Lublin Department of Medicinal Chemistry, Pharmaceutical Faculty Jaczewskiego 4 20-090 Lublin Poland,
Skibiński, R.
Medical University of Lublin Department of Medicinal Chemistry, Pharmaceutical Faculty Jaczewskiego 4 20-090 Lublin Poland, robert.skibinski@am.lublin.pl,
Paw, B.
Medical University of Lublin Department of Medicinal Chemistry, Pharmaceutical Faculty Jaczewskiego 4 20-090 Lublin Poland,
Działo, G.
Medical University of Lublin Department of Medicinal Chemistry, Pharmaceutical Faculty Jaczewskiego 4 20-090 Lublin Poland,
Sajewicz, M.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland,
Matlengiewicz, M.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland,
Kronenbach, D.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland,
Gontarska, M.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland,
Kowalska, T.
Silesian University Institute of Chemistry 9 Szkolna Street 40-006 Katowice Poland, kowalska@us.edu.pl,
Ekiert, R. J.
Jagiellonian University Department of Inorganic and Analytical Chemistry, Collegium Medicum 9 Medyczna St 30-688 Kraków Poland,
Krzek, J.
Jagiellonian University Department of Inorganic and Analytical Chemistry, Collegium Medicum 9 Medyczna St 30-688 Kraków Poland, jankrzek@cm-uj.krakow.pl,
Czekaj, J. S.
Jagiellonian University Department of Inorganic and Analytical Chemistry, Collegium Medicum 9 Medyczna St 30-688 Kraków Poland,
Hubicka, U.
Jagiellonian University Department of Inorganic and Analytical Chemistry, Collegium Medicum 9 Medyczna St 30-688 Kraków Poland,
Azeem, A.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India,
Rizwan, M.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India,
Ahmad, F. J.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India,
Iqbal, Z.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India,
Khar, R. K.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India,
Aqil, M.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India,
Talegaonkar, S.
Faculty of Pharmacy Department of Pharmaceutics Jamia Hamdard, New Delhi 110062 India, stalegaonkar@jamiahamdard.ac.in,
Abstract : An accurate, sensitive, precise, rapid and isocratic reversed-phase HPLC (RPHPLC) method for analysis of buspirone in the bulk drug and in solid dosage formulations has been developed and validated. The best separation was achieved on a 250 mm × 4.6 mm i.d., 5-μm particle, RP C 18 column with 70:30 ( υ/υ ) methanol-0.01 M sodium dihydrogen phosphate buffer (pH 3.5) as mobile phase at a flow rate of 0.8 mL min-1. UV detection was at 244 nm. Response was a linear function of concentration over the range 0.05–20 μg mL-1( r = 0.9998) and the limits of detection and quantitation were 3.7 and 11.3 ng mL-1, respectively. The method was validated in accordance with ICH guidelines. The drug was subjected to oxidative, hydrolytic, photolytic, and thermal stress. Degradation products produced as a result of this stress did not interfere with detection of buspirone and the assay can thus be regarded as stability-indicating. The method was used for quantification of buspirone in commercial buspirone tablets and to check content uniformity. The excipients present in the formulation did not interfere with the assay. The method is suitable for application in quality-control laboratories, because it is simple and rapid with good accuracy and precision.

Keywords : buspirone, reversed-phase HPLC, validation, assay, quality control, stability-indicating method, forced degradation studies,
Publishing house : University of Silesia in Katowice
Publication date : 2009
Number : Vol. 21, no. 2
Page : 283 – 297

Bibliography
: 1 A.S. Eison and D.L. Temple, Am. J. Med., 80 , 1 (1986)
2 K.L. Goa and A. Ward, Drugs, 32 , 114 (1986)
3 H. Goldberg, Pharmacotherapy, 4 , 315 (1994)
4 R. Krysiak, E. Obuchowicz, and Z.S. Herman, Neur. Res., 51 , 924 (1986)
5 Z. Chilmonckyk, H. Ksycinska, J. Cybulski, and A. Wozniakowska-Szelejewska, Die Pharm., 51 , 924 (1986)
6 A. Gobert, A. Newman-Tancredi, J.M. Rivet, V. Audinot, and M.J. Millan, Eur. Neuropyschopharmacol., 7 , S149 (1997)
7 S.M. Fouroton, A. Zarghi, A.R. Shafaati, and A. Khoddam, Farmaco, 59 , 739 (2004)
8 X. Aparicio, A. Campos, J. Gras, E. Fernandez, and E. Gelpi, J. Pharm. Biomed. Anal., 6 , 945 (1988)
9 P. Betto, A. Meneguz, G. Ricciarello, E. Fernandez, and C. Pichini, J. Chromatogr., 575 , 117 (1992)
10 M. Franklin, J. Chromatogr., 526 , 590 (1990)
11 J. Odontiadis and M. Franklin, J. Pharm. Biomed. Anal., 14 , 347 (1996)
12 W.M. Chew, M-J. Xu, C.A. Cordova, and H-H. Sherrychow, J. Chromatogr. B, 844 , 25 (2006)
13 S-H. Cho, H-W. Lee, H-T. Im, W-S. Park, Y-W. Choi, J-H. Rew, and K-T. Lee, Rapid Commun. Mass Spectrom., 20 , 1293, (2006)
14 E. Nagele and A.S. Fandino, J. Chromatogr. A, 1156 , 196 (2007)
15 J.W. Hager and J.C. YvesLeBlanc, J. Chromatogr. A, 1020 , 3 (2003)
16 F. Kristjannson, J. Chromatogr., 566 , 250 (1991)
17 T.H. Tsai and C.F. Chen, J. Chromatogr. A, 762 , 269 (1997)
18 E.H. Kerns, R.A. Routick, K.J. Volk, and M.S. Lee, J. Chromatogr. B, 698 , 133 (1997)
19 C.A. Goldthwaite Jr, F-Y. Hsieh, S.W. Womble, B.J. Noves, and I.A. Blair, Anal. Chem., 68 , 2996 (1996)
20 M.G. Quaglia, A. Farina, E. Bossu, and C.D. Aquila, J. Pharm. Biomed. Anal., 13 , 505 (1995)
21 S.M. Sabry, M.H. Barary, M.H. Abdel Hay, and T.S. Belal, J. Pharm. Biomed. Anal., 34 , 509 (2004)
22 A. Khedr and A. Sekr, J. Chromatogr. Sci., 37 , 462 (1999)
23 M. Zaxariou and I. Panderi, J. Pharm. Biomed. Anal., 35 , 41 (2004)
24 Z. Plotkowiak, J. Cybulski, M. Popielarz-Brzezinska, A. Grzeszkiewicz, I. Centrowska, and A. Kalska-Kowalska, Chem. Anal., 41 , 983 (1996)
25 N. Adel-Ghani, Y. Issa, A. Shoukry, and H. Ahmed, Ann. Chim., 97 (2007)
26 J.A. Squella, Y. Borges, L. Bobadilla, and L.J. Nunez-Vergara, Electroanal. J., 4 , 333 (1990)
27 W.M.A. Niessen, J. Lin, and G.C. Bondoux, J. Chromatogr. A, 970 , 131 (2002)
28 RT. Sane, N.L. Chonken, S.R. Surve, M.G. Gangrade, and V.V. Bapat, Indian Drugs, 30 , 235 (1993)
29 V.C. Jacob, S.N. Murthy, J. Saravanan, and J. Ravishankar, Indian Drugs, 34 , 24 (1997)
30 International Conference on Harmonization (ICH), Validation of Analytical Procedures: Text and Methodology Q2 (R1), November 2005
31 S.C. Chow and J. Shao, Statistics in Drug Research: Methodologies and Recent Developments, Marcel Dekker, 2002, pp. 31–52
32 M. Zeaiter, J.M. Roger, V.B. Maurel, and D.N. Rutledge, Trends Anal. Chem., 23 , 157 (2004)
33 M. Mulholland, Trends Anal. Chem., 7 , 383 (1988)
34 ICH, Stability Testing of New Drug Substances and Products (Q1AR). International Conference on Harmonisation, IFPMA, Geneva, 2000
35 ICH, Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances. International Conference on Harmonisation, IFPMA, Geneva, 1999
36 International Conference on Harmonization (ICH), Guidance for Industry, Q1A (R2): Stability Testing of New Drug Substances and Products, IFPMA, Geneva, 2003
DOI :
Qute : Dejaegher, B. ,Vander Heyden, Y. ,Durón, R. R. ,Almaguer, L. C. ,Garza-Juárez, A. ,Salazar Cavazos, M. L. ,Waksman de Torres, N. ,Garza-Juárez, A. ,Waksman de Torres, N. ,Salazar Cavazos, M. L. ,Durón, R. R. ,Briciu, R. D. ,Kot-Wasik, A. ,Namieśnik, J. ,Sârbu, C. ,Sławik, T. ,Skibiński, R. ,Paw, B. ,Działo, G. ,Sajewicz, M. ,Matlengiewicz, M. ,Kronenbach, D. ,Gontarska, M. ,Kowalska, T. ,Ekiert, R. J. ,Krzek, J. ,Czekaj, J. S. ,Hubicka, U. ,Azeem, A. ,Rizwan, M. ,Ahmad, F. J. ,Iqbal, Z. ,Khar, R. K. ,Aqil, M. ,Talegaonkar, S. ,Talegaonkar, S. , Development and validation of a stability-indicating LC-UV method for rapid analysis of buspirone in pharmaceutical dosage forms. Acta Chromatographica Vol. 21, no. 2/2009
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