A validated stability-indicating LC method for simultaneous determination of quinapril and hydrochlorothiazide in pharmaceutical samples

• Authors: Marta Diego , Sigrid Mennickent , Juan Muñoz , Fernanda Sanhueza , Ricardo Godoy
• Languages of publication: EN

Abstracts

EN

A stability-indicating liquid chromatographic method was developed and validated for simultaneous determination of quinapril and hydrochlorothiazide in drug substances and dosage forms. Chromatographic separation of quinapril, hydrochlorothiazide and its degradation products was achieved on a RP-18 column, using acetonitrile and phosphate buffer (pH 4.6) as mobile phase in a gradient mode and detection at 216 nm. Stress testing was performed under hydrolytic, oxidative, thermal and photolytic conditions. The degradation products were well resolved from main peaks, proving the stability-indicating power of the method. The assay was linear for quinapril and hydrochlorothiazide concentrations of 40–200 µg mL−1 and 25–125 µg mL−1, respectively. The developed method was selective, accurate and precise for quinapril and hydrochlorothiazide determination. This method was used to quantify both drugs in combined commercial tablets. The results showed that the proposed method was found to be suitable for quantitative determination and the stability study of quinapril and hydrochlorothiazide in pharmaceutical samples.

Keywords

EN

Hydrochlorotiazide; Quinapril; Simultaneous determination; Stability-indicating; Stress testing

• Publisher: De Gruyter Open
• Journal: Open Chemistry
• Year: 2014
• Volume: 12
• Issue: 4
• Pages: 470-475

Dates

published

1 - 4 - 2014

online

16 - 1 - 2014

Contributors

author

Marta Diego

• University of Concepción

author

Sigrid Mennickent

• University of Concepción

author

Juan Muñoz

• University of Concepción

author

Fernanda Sanhueza

• University of Concepción

author

Ricardo Godoy

• University of Concepción

References

• [1] G.K. Mc Evoy, AHFS Drug Information (American Society of Health-System Pharmacists, Bethesda, 2012) 2014
• [2] G.K. Mc Evoy, AHFS Drug Information (American Society of Health-System Pharmacists, Bethesda, 2012) 2818
• [3] B. Stanisz, S. Paszun, N. Strzyzycka, E. Ptaszynski, Acta Pol. Pharm. 67 99 (2010)
• [4] A. Freed, S. Silbering, K. Kolodsick, D. Rossi, M. Mahjour, C. Kingsmill, Int. J. Pharmaceut. 304, (2005) 135 http://dx.doi.org/10.1016/j.ijpharm.2005.08.007[Crossref]
• [5] B. Stanisz, Acta Pol. Pharm. 62, 189 (2005) [PubMed]
• [6] B. Stanisz, Acta Pol. Pharm. 60, 443 (2003) [PubMed]
• [7] M. Lusina, T. Cindric, J. Tomaic, M. Peko, L. Pozaic, N. Musulin, Int. J. Pharmaceut. 291, 127 (2005) http://dx.doi.org/10.1016/j.ijpharm.2004.07.050[Crossref]
• [8] D. Hertzog, J. Finnegan, X. Fang, J. Tyrrell, R. Reed, J. Pharm. Biomed. Anal. 30, 747 (2002) http://dx.doi.org/10.1016/S0731-7085(02)00385-0[Crossref]
• [9] K. Deventer, G. Baele, P. Van Eenoo, O. Pozo, F. Delbeke, J. Pharm. Biomed. Anal. 49, 519 (2009) http://dx.doi.org/10.1016/j.jpba.2008.11.001[Crossref]
• [10] X. Fang, R. Todd, S. Mayr, W. Yin, P. Harmon, J. Finnegan, R. Jeffrey, R. Reed, J. Pharm. Sci. 90, 1800 (2001) http://dx.doi.org/10.1002/jps.1130[Crossref]
• [11] M. De Diego, S. Mennickent, G. Godoy, V. Miranda, Curr. Pharm. Anal. 7, 248 (2011) http://dx.doi.org/10.2174/157341211797458005[Crossref]
• [12] The United States Pharmacopeia (The United States Pharmacopeial Convention, Inc, Rockville, 2012) 838
• [13] D. Durga, N. Satyanarayana, S. Sait, Y. Ramakoti, K. Mukkanti, Chromatographia. 70, 647 (2009) http://dx.doi.org/10.1365/s10337-009-1221-x[Crossref]
• [14] F. Belal, I. Al-Zaagi, E. Gadkariem, J. Pharm. Biomed. Anal. 24, 335 (2001) http://dx.doi.org/10.1016/S0731-7085(00)00474-X[Crossref]
• [15] M. Hegazy, F. Metwaly, M. Abdelkawy, N. Abdelwahab, J. Chromatogr. Sci. 49, 129 (2011) http://dx.doi.org/10.1093/chrsci/49.2.129[Crossref]
• [16] V. Rane, K. Patil, J. Sangshetti, R. Yeole, D. Shinde, J. Chromatogr. Sci. 48, 595 (2010) http://dx.doi.org/10.1093/chromsci/48.7.595[Crossref]
• [17] S. Nalwade, V. Ranga, D. Durga, I. Koteswara, Scientia Pharm. 79, 69. (2011) http://dx.doi.org/10.3797/scipharm.1006-10[Crossref]
• [18] M. Gandhimathi, T. Ravi, Indian J. Pharm. Sci. 71, 311 (2009) http://dx.doi.org/10.4103/0250-474X.56035[Crossref]
• [19] G. Bhavar, V. Chatpalliwar, D. Patil, S. Surana, Indian J. Pharm. Sci. 70, 529 (2008) http://dx.doi.org/10.4103/0250-474X.44612[Crossref]
• [20] D. Kowalczuk, H. Hopkala, J. AOAC Int. 87, 847 (2004)
• [21] S. Hillaert, K. De Grauwe, W. Van den Bossche, J. Chromatogr. A. 924, 439 (2001) http://dx.doi.org/10.1016/S0021-9673(01)00714-2[Crossref]
• [22] S. Parekh, A. Pudage, S. Joshi, V. Vaidya, N. Gomes, S. Kamat, J. Chromatogr. B. 873, 59 (2008) http://dx.doi.org/10.1016/j.jchromb.2008.07.046[Crossref]
• [23] ICH Q2B, Validation of Analytical Procedures, Methodology (International Conference on Harmonization, Geneva, 1996)
• [24] ICH Q1 A (R2), Stability Testing of New Drug Substances and Products (International Conference on Harmonization, Geneva. 2003) [PubMed]
• [25] S.W. Baertschi, Pharmaceutical Stress Testing, Predicting Drug Degradation (Taylor & Francis Group, Boca Raton, 2005) 142 http://dx.doi.org/10.1201/9780849359194[Crossref]
• [26] ICH Q1 B, Photostability Testing of New Drug Substances and Products (International Conference on Harmonization, Geneva, 1996)

Identifiers

DOI

10.2478/s11532-013-0396-z