Development and validation of a fast, simple, cost-effective and robust HPLC method for lisinopril determination in solid pharmaceutical dosage forms
DOI:
https://doi.org/10.20450/mjcce.2017.1210Keywords:
lisinopril dihydrate, tablets, HPLC, optimization, validationAbstract
A fast, simple, cost-effective and robust chromatographic method was developed and validated for determination of the antihypertensive drug lisinopril dihydrate in tablets under routine operational conditions, without ion-pair reagents, high column temperatures and an acidic mobile phase. Taking into consideration all four different pKa values of lisinopril, the separation was optimized using the C18 column (end-capped, 150 mm × 4.6 mm 5 µm) and a mobile phase composed of methanol and ammonium (or potassium) dihydrogen phosphate buffer (pH 7.2) with a flow rate of 1.1 ml/min, UV detection at 214 nm and a temperature of 40 °C. These optimized conditions led to the production of a single and symmetrical peak for lisinopril. This mobile phase is suitable for different HPLC columns, which makes it appropriate for industrial quality control laboratories. The developed method was validated, showing excellent validation results and the possibility to be implemented for the determination of lisinopril in combined dosage forms with other active substances.
References
European Pharmacopoeia, 8th ed., European Directorate for the Quality of Medicines – Council of Europe, Strasbourg, 2014.
A. Patchett, E. Harris, E. Tristram, M. Wyvratt, M. Wu, D. Taub, E. Peterson, T. Ikeler, J. ten Broeke, L. Payne, D. Ondeyka, E. Thorsett, W. Greenlee, N. Lohr, R. Hoffsommer, H. Joshua, W. Ruyle, J. Rothrock, S. As-ter, A. Maycock, F. Robinson, R. Hirschmann, C. Sweet, E. Ulm, D. Gross, T. Vassil, C. Stone, A new class of angiotensin-converting enzyme inhibitors, Nature, 288 (5788), 280–283 (1980).
DOI: http://dx.doi.org/10.1038/288280a0
Consumer Reports Health Best Buy Drugs, Using ACE inhibitors to treat: High blood pressure and heart dis-ease comparing effectiveness, safety and price, Consum-ers Union of United States, Inc., March 2011.
British Pharmacopoeia Commission, British Pharmaco-poeia 2013, The Stationery Office, Norwich, 2012.
United States Pharmacopeia and National Formulary (USP 36–NF 31), United States Pharmacopeia Conven-tion, Rockville, 2012.
Society of Japanese Pharmacopoeia, Japanese Pharmacopoeia, 16th ed., Tokyo, Maruzen Company Ltd., 2012.
A. El-Gindy, A. Ashour, L. Abdel-Fattah, M. M. Shabana, Spectrophotometric, spectrofluorometric and LC determination of lisinopril, J. Pharm. Biomed. Anal., 25 (5–6), 913–922 (2001).
DOI: http://dx.doi.org/10.1016/S0731-7085(01)00376-4
B. Stanisz, Kinetics of lisiopril degradation in solid phase, React. Kinet. Catal. Lett., 85 (1), 145–152 (2005).
DOI: http://dx.doi.org/10.1007/s11144-005-0254-x
C. A. Beasley, J. Shaw, Z. Zhao, R. A. Reed, Develop-ment and validation of a stability indicating HPLC method for determination of lisinopril, lisinopril degradation product and parabens in the lisinopril extemporaneous formulation. J. Pharm. Biomed. Anal., 37 (3), 559–567 (2005).
DOI: http://dx.doi.org/10.1016/j.jpba.2004.11.021
S. N. L. Rao, U. N. Rani, Estimation of lisinopril in tablets by RP-HPLC method, Int. J. Chem. Sci., 7 (2), 1462–1466 (2009).
R. Ludwig, Analysis of lisinopril by LC/UV using a core enhanced technology accucore RP-MS column, LCGC ASIA PACIFIC, 14 (3), 38 (2011).
E. Adam, I. Barakat, A. Saeed, Development and valida-tion of a high performance liquid chromatography method for the determination of lisinopril dihydrate, Asian J. Pharm. Biol. Res., 2 (2), 94–99 (2012).
V. B. Raju, A. L. Rao, Development, estimation and vali-dation of lisinopril in bulk and its pharmaceutical formula-tion by HPLC method, E-J. Chem., 9 (1), 340–344 (2012). DOI: http://dx.doi.org/10.1155/2012/292754
V. Chander, M. Mohan, R. Seth, P. Singh, R. Singh, S. Gupta, Development and validation of RP-HPLC method for estimation of lisinopril in tablet dosage form, Anal. Chem. Lett. 2 (5), 309–313 (2012).
DOI: http://dx.doi.org/10.1080/22297928.2012.10648282
V. Maslarska, J. Tencheva, Development of analytical method for determination of lisinopril tablets using RP-HPLC method, Int. J. Pharm. Bio. Sci., 4 (4), 163–167 (2013).
N. D. Preetham, K. Sujana, S. D. P. Sankar, Develop-ment and validation of UV spectrophoto¬metric method for the estimation of lisinopril in bulk and pharmaceutical formulation, Int. J. Pharm. Sci. Rev. Res., 25 (1), 257–259 (2014).
A. F. El-Yazbi, H. H. Abdine, A. R. Shaalan, Spectro-photometric and spectrofluorometric methods for the as-say of lisinopril in single and multicomponent pharma-ceutical dosage forms, J. Pharm. Biomed. Anal., 19 (6), 819–827 (1999).
DOI: http://dx.doi.org/10.1016/S0731-7085(98)00110-1
G. Paraskevas, J. Atta-Politou, M. Koupparis, Spectro-photometric determination of lisinopril in tablets using 1-fluoro-2,4-dinitrobenzene reagent, J. Pharm. Biomed. Anal., 29 (5), 865–872 (2002).
DOI: http://dx.doi.org/10.1016/S0731-7085(02)00207-8
S. E. Aktas, L. Ersoy, O. Sagirli, A new spectrofluorimetric method for the determination of lisinopril in tablets, II Farmaco 58 (2), 165–168 (2003).
DOI: http://dx.doi.org/10.1016/S0014-827X(02)00013-7
A. A. El-Emam, S. H. Hansen, M. A. Moustafa, S. M. El-Ashry, D. T. El-Sherbiny, Determination of lisinopril in dosage forms and spiked human plasma through derivatization with 7-chloro-4-nitrobenzo-2-oxa-1,3-diazole (NBD-Cl) followed by spectrophotometry or HPLC with fluorimetric detection, J. Pharm. Biomed. Anal., 34 (1), 35–44 (2004).
DOI: http://dx.doi.org/10.1016/j.japna.2003.08.021
N. Rahman, N. Anwar, M. Kashif, Application of π-acceptors to the spectrophotometric determination of lisinopril in commercial dosage forms, II Farmaco, 60 (6–7), 605–611 (2005).
DOI: http://dx.doi.org/10.1016/j.farmac.2005.04.011
A. Raza, M. T. Ansari, Atta-ur-Rehman, Spectrophoto-metric determination of lisinopril in pure and pharma-ceutical formulations, J. Chin. Chem. Soc., 52 (5), 1055–1059 (2005). DOI: 10.1002/jccs.200500149
M. C. Jamakhandi, C. Javali, I. J. Disouza, S. U. Chougule, K. A. Mullani, Spectrophoto¬metric determi-nation of lisinopril dosage form by condensation reaction, Int. J. Pharm. Sci., 3 (2), 185–187 (2011).
D. Özer, H. Senel, Determination of lisinopril from phar-maceutical preparations by derivative UV spectrometry, J. Pharm. Biomed. Anal., 21 (3), 691–695 (1999).
DOI: http://dx.doi.org/10.1016/S0731-7085(99)00168-5
B. Stanisz, Estimation of the applicability of differential spectroscopic method for the determination of lisinopril in tablets and for the evaluation of its stability, Acta Pol. Pharm., 61 (5), 327–334 (2004).
M. Remko, Acidity, lipophilicity, solubility, absorption and polar surface area of some ACE inhibitors, Chem. Pap.-Chem. Zvesti, 61 (2), 133–141 (2007).
DOI: http://dx.doi.org/10.2478/s11696-007-0010-y
Technical overview, Control pH during Method Devel-opment for Better Chromatography, Agilent Technolo-gies Inc., USA, 2015.
Y. Kazakevich, R. Lobrutto (Editors), HPLC for Phar-maceutical Scientists, John Wiley & Sons, New Jersey, USA, 2007.
A. Kocijan, R. Grahek, D. Kocijan, L. Kralj-Zupančič, Effect of column temperature on the behaviour of some angiotenzin converting enzyme inhibitors during high-performance liquid chromatographic analysis, J. Chromatogr. B: Biomed. Sci. Appl., 755 (1–2), 229–235 (2001). DOI: http://dx.doi.org/10.1016/S0378-4347(01)00082-2
S. Bouabdallah, H. Trabelsi, K. Bouzouita, S. Sabbah, Reversed-phase liquid chromatography of lisinopril con-formers, J. Biochem. Biophys. Methods, 54 (1–3), 391–405 (2002).
DOI: http://dx.doi.org/10.1016/S0165-022X(02)00140-9
International Conference on Harmonization (ICH) of technical requirements for registration of pharmaceuticals for human use, Validation of analytical procedures: Text and methodology Q2(R1), ICH, Geneva, Switzerland, 2005.
