Journal : Acta Chromatographica
Article : Validation of an analytical procedure for simultaneous determination of hydrochlorothiazide, lisinopril, and their impurities

Authors :
Bartnik, M.
Department of Pharmacognosy with Medicinal Plant Laboratory, Medical University, 1, Chodźki Str., 20-093 Lublin, Poland,
Kowalski, R.
Subdepartment of Food Quality Assessment and Central Apparatus Laboratory, Agricultural University, 20-950 Lublin, Akademicka 13, Poland,
Polak, B.
Department of Physical Chemistry, Faculty of Pharmacy, Medical University, Lublin, Poland,
Turło, J.
Department of Drug Technology, Medical University of Warsaw, 1, Banacha Street, 02-097 Warsaw, Poland,
Szyrwińska, K.
Department of Inorganic and Analytical Chemistry, Faculty of Pharmacy, Poznań University of Medical Sciences, Grunwaldzka 6, 60-780 Poznań, Poland,
Czauderna, M.
The Kielanowski Institute of Animal Physiology and Nutrition, Polish Academy of Sciences, 05-110 Jabłonna, Poland,
Bączek, T.
Medical University of Gdańsk, Department of Biopharmaceutics and Pharmacodynamics, Gdańsk, Poland,
Chilmonczyk, Z.
National Medicines Institute, 30/34, Chełmska Str., 00-725 Warsaw, Poland,
Hung, Ch. Y.
Department of Biotechnology, National Formosa University, Huwei, Yunlin, 632, Taiwan,
Baboota, S.
Department of Pharmaceutics, Faculty of Pharmacy, Jamia Hamdard, Hamdard Nagar, New Delhi-110062, India,
Sivakumar, T.
Department of Pharmacy, Annamalai University, Annamalai Nagar, Tamil Nadu-608 002, India,
Ivanović, D.
Faculty of Pharmacy, Department of Drug Analysis, Vojvode Stepe 450, 11000 Belgrade, Serbia,
Abstract : The main objective of the work discussed in this paper was evaluation of a chromatographic method for simultaneous determination of hydrochlorothiazide (HCTZ), lisinopril (L), and their impurities in pharmaceuticals. Chlorothiazide (CTZ) and disulfonamide (DSA), as potential impurities in hydrochlorothiazide, and diketopiperazine (DKP), as an impurity of lisinopril, were analyzed. The chromatographic behaviour of these substances on different columns was studied using mobile phases of different polarity. The optimum separations were achieved by gradient elution on a 4.6 mm × 20 mm, 3.5 µm particle size, C18 column. The mobile phase was a gradient prepared by mixing 7:93 (v/v) acetonitrile–25 mM potassium dihydrogen phosphate, pH 5, and 50:50 (v/v) acetonitrile–25 mM potassium dihydrogen phosphate pH 5 in different ratios. The flow rate was 1.0 mL min-1. UV detection was performed at 215 nm. Methylparaben was used as internal standard. The method was validated for selectivity, linearity, precision, and accuracy. The limits of detection, LOD, and quantification, LOQ, were determined experimentally. Because of its speed and accuracy the method can be used for quality-control analysis.

Keywords :
Publishing house : University of Silesia in Katowice
Publication date : 2007
Number : No. 18
Page : 143 – 156

Bibliography
: 1 G. Paraskevas, J. Atta-Politou, and M. Koupparis, J. Pharm. Biomed. Anal., 29, 865 (2002)
2 A. El-Gindy, A. Ashour, L. Abdel-Fattah, and M. Shabana, J. Pharm. Biomed. Anal., 25, 913 (2001)
3 M. Kartal and N. Erk, J. Pharm. Biomed. Anal., 19, 477 (1999)
4 M. Ferraro, P. Castellano, and T. Kaufman, J. Pharm. Biomed. Anal., 30, 1121 (2002)
5 E. Dinc and A. Ozdemir, Il Farmaco, 60, 591 (2005)
6 E. Satana, S. Altinay, N. Goger, S. Ozkan, and Z. Senturk, J. Pharm. Biomed. Anal., 25, 1009 (2001)
7 S. Saglik, O. Sagirli, S. Atmaca, and L. Ersoy, Anal. Chim. Acta, 427, 253 (2001)
8 C. Beasley, J. Shaw, Z. Zhao, and R. Reed, J. Pharm. Biomed. Anal., 37, 559 (2005)
9 A. El-Gindy, A. Ashour, L. Abdel-Fattah, and M. Shabana, J. Pharm. Biomed. Anal., 25, 913 (2001)
10 S. Bouabdallah, H. Trabelsi, K. Bouzouita, and S. Sabbah, J. Biochem. Biophys. Methods, 54, 391 (2002)
11 O. Sagirli and L. Ersoy, J. Chromatogr. B, 809, 159 (2004)
12 A. El-Gindy, A. Ashour, L. Abdel-Fattah, and M. Shabana, J. Pharm. Biomed. Anal., 25, 171 (2001)
13 S. Saglik, O. Sagirli, S. Atmaca, and L. Ersoy, Anal. Chim. Acta, 427, 253 (2001)
14 F. Belal, I. Al-Zaagi, E. Gadkariem, and M. Abounassif, J. Pharm. Biomed. Anal., 24, 335 (2001)
15 D. Ivanović, M. Medenica, A. Malenović, and B. Jančić, Accredit. Qual. Assur., 9, 76 (2004)
16 D. Hertzog, J. McCafferty, X. Fang, R. Tyrrell, and R. Reed, J. Pharm. Biomed. Anal., 30, 747 (2002)
17 E. Satana, S. Altinay, N. Goger, S. Ozkan, and Z. Senturk, J. Pharm. Biomed. Anal., 25, 1009 (2001)
18 G. Carlucci, G. Palumbo, P. Mazzeo, and M. Quaglia, J. Pharm. Biomed. Anal., 23, 185, (2000)
19 N. Erk, J. Pharm. Biomed. Anal., 24, 603 (2001)
20 M. Zečević, Lj. Zivanovic, S. Agatonović-Kustrin, D. Ivanović, and M. Maksimovic J. Pharm. Biomed. Anal., 22, 1 (2000)
21 J. Franolic, G. Lehr, T. Barry, and G. Petzinger, J. Pharm. Biomed. Anal., 26, 651 (2001)
22 D. Farthing, I. Fakhry, E. Replay, and D. Sicca, J. Pharm. Biomed. Anal., 17, 1455 (1998)
23 K. Richter, R. Oertel, and W. Kirch, J. Chromatogr. A, 729, 293 (1996)
24 O. Razak, J. Pharm. Biomed. Anal., 34, 433 (2004)
25 R. Gotti, V. Andrisano, V. Cavrini, C. Bertucci, and S. Furlanetto, J. Pharm. Biomed. Anal., 22, 423 (2000)
26 The United States Pharmacopeia 28/National Formulary 23, United States Pharmacopeia Convention, Rockville, MD, 2004
27 British Pharmacopeia, The Pharmaceutical Press, London, 2004
DOI :
Qute : Bartnik, M. ,Kowalski, R. ,Polak, B. ,Turło, J. ,Szyrwińska, K. ,Czauderna, M. ,Bączek, T. ,Chilmonczyk, Z. ,Hung, Ch. Y. ,Baboota, S. ,Sivakumar, T. ,Ivanović, D. ,Ivanović, D. , Validation of an analytical procedure for simultaneous determination of hydrochlorothiazide, lisinopril, and their impurities. Acta Chromatographica No. 18/2007
facebook