RP-HPLC Method for the Simultaneous Determination of Lisinopril and NSAIDs in API, Pharmaceutical Formulations and Human Serum

Najma Sultana, M. Saeed Arayne, Rubina Siddiqui, Safila Naveed

Fatima Jinnah Medical and Dental College, Karachi, Pakistan.
Jinnah University for Women, Karachi, Pakistan.
United Biotechnologies, Karachi, Pakistan.

DOI: 10.4236/ajac.2012.32021                

Abstract

High performance liquid chromatographic method was developed valdated and applied for the simultaneous determi- nation of lisinopril and NSAIDs in bulk, pharmaceuticals formulations and human serum. A Purospher star C18 (5 μm, 25 × 0.46 cm) column was used with mobile phase consisting of methanol: water: acetonitrile (80:17.5:2.5 v/v, pH 3.0) and quantitative evaluation was performed at 225 nm with a flow rate of 1.0 mL?min–1. The retention time of lisinopril was 2.2 min while naproxen, flurbiprofen, diclofenac sodium and mefenamic acid were found to be 4.0, 4.5, 5.0 and 6.7 min respectively. Suitability of this method for the quantitative determination of the drugs was proved by validation in accordance with the requirements laid down by International Conference on Harmonization (ICH) guidelines. The method is selective, precise, accurate and can be used for analysis of pharmaceutical preparations in quality control and clinical laboratories.

Keywords

Lisinopril; NSAIDs; Method Validation; HPLC Determination

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1]	A. A. Patchett, E. Harris, E. W. Tristram, M. J. Wyvratt, M. T. Wu, D. Taub, E. R, Peterson, T. J. Ikeler, J. Broeke, L. G. Payne, D. L. Ondeyka, E. D. Thorsett, W. J. Greenlee, N. S Lohr, R. D. Hoffsommer, H. Joshua, W. E. Ruyle, J. W. Rothrock, S. D. Aster, A. L. Maycock, F. M. Robinson, R. Hirschmann, C. S Sweet, E. H. Ulm, D. L. Gross, T. C. Vassil and C. A. Stone, “A New Class of Angiotensin-Converting Enzyme Inhibitors,” Nature, Vol. 288, No. 5788, 1980, pp. 280-283. doi:10.1038/288280a0
[2]	“Lisinopril,” The American Society of Health-System Pharmacists, Retrieved 14 July 2011. http://www.drugs.com/monograph/lisinopril.html
[3]	N. Chaturvedi, A. K. Sjolie, J. M. Stephenson, H. Abra- hamian, M. Keipes, A. Castellarin, Z. Rogulja-Pepeonik and J. H. Fuller, “Effect of Lisinopril on Progression of Retinopathy in Normo-tensive People with Type 1 Diabetes. The EUCLID Study Group. EURODIAB Controlled Trial of Lisinopril in Insulin-Dependent Diabetes Mellitus,” Lancet, Vol. 351, No. 9095, 1998, pp. 28-31.
[4]	B. Hinz, O. Cheremina and K. Brune, “Acetaminophen (Paracetamol) Is a Selective Cyclooxygenase-2 Inhibitor in Man,” The FASEB Journal: Official Publication of the Federation of American Societies for Experimental Biology, Vol. 22, No. 2, 2008, pp. 383-390.
[5]	N. Sultana, M. S. Arayne and R. U. Quraishi, “In vitro Interactions of Captopril with NSAID’s,” Pakistan Journal of Pharmaceutical Sciences, Vol. 19, No. 3, 2006, pp. 202-207.
[6]	E. A. Chrischilles and R. B. Wallace, “Nonsteroidal Anti- Inflammatory Drugs and Blood Pressure in an Elderly Population,” Journals of Gerontology, Vol. 48, No. 3, 1993, pp. M91-M96.
[7]	J. H. Gurwitz, D. E. Everitt, M. Monane, R. J. Glynn, I. Choodnovskiy, M. P. Beaudet and J. Avorn, “The Impact of Ibuprofen on the Efficacy of Antihypertensive Treatment with Hydrochlorothiazide in Elderly Persons,” The Journals of Gerontology Series A: Biological Sciences and Medical Sciences, Vol. 51, No. 2, 1996, pp. M74-M79. doi:10.1093/gerona/51A.2.M74
[8]	M. D .Guazzi, J. Campodonico, F. Celeste, M. Guazzi, G. Santambrogio, M. Rossi, D. Trabattoni and M. Alimento, “Antihypertensive Effi-cacy of Angiotensin Converting Enzyme Inhibition and Aspirin Counteraction,” Clinical Pharmacology & Therapeutics, Vol. 63, No. 1, 1998, pp. 79-86. doi:10.1016/S0009-9236(98)90123-0
[9]	J. H. Gurwitz, J. Avorn, R. L. Bohn, R. J. Glynn, M. Monane and H. Mogun, “Initiation of Antihypertensive Treatment during Nonsteroidal Anti-Inflammatory Drug Therapy,” Journal of the American Medical Association (JAMA), Vol. 272, No. 10, 1994, pp. 781-786. doi:10.1001/jama.1994.03520100043031
[10]	J. Polónia, I. Boaventura, G. Gama, I. Cam?es, F. Bernardo, P. Andrade, J. P. Nunes, F. Brand?o and M. Cerqueira-Gomes, “Influence of Non-Steroidal Anti-In- flammatory Drugs on Renal Function and 24 h Ambula- tory Blood Pressure-Reducing Effects of Enalapril and Nifedipine Gastrointestinal Therapeutic System in Hypertensive Patients,” Journal of Hypertension, Vol. 13, No. 8, 1995, pp. 925-931. doi:10.1097/00004872-199508000-00014
[11]	W. Linz, G. Wiemer, P. Gohlke, T. Unger and B. A. Sch?lkens, “Contribu-tion of Kinins to the Cardiovascular Actions of Angioten-sin-Converting Enzyme Inhibitors,” Pharmacological Reviews, Vol. 47, No. 1, 1995, pp. 25- 49.
[12]	V. Kumar, S. Malik and S. Singh, “Polypill for the Treatment of Cardiovascular Diseases Part 2. LC-MS/ TOF Characterization of Interaction/Degradation Pro- ducts of Atenolol/Lisinopril and Aspirin, and Mechanisms of Formation Thereof,” Journal of Pharmaceutical and Biomedical Analysis, Vol. 48, No. 3, 2008, pp. 619-628. doi:10.1016/j.jpba.2008.06.003
[13]	K. Dubey, D. K. Balani, C. B. Tripathi, R. Singh, R. Bajaj and K. K. Pillai, “Adverse Interactions of Rofecoxib with Lisinopril in Spontaneously Hypertensive Rats,” Clinical toxicology, Vol. 43, No. 5, 2005, pp. 361-373. doi:10.1081/CLT-200066053
[14]	R. Fogari, A. Zoppi, R. Carretta, F. Veglio, A. Salvetti and Italian Collaborative Study Group, “Effect of Indo- methacin on the Antihypertensive Ef-ficacy of Valsartan and Lisinopril: A Multicentre Study,” Journal of Hypertension, Vol. 20, No. 5, 2002, pp. 1007-1014. doi:10.1097/00004872-200205000-00037
[15]	C. H. Brown, “Effect of Rofecoxib on the Antihypertensive Activity of Lisi-nopril,” The Annals of Pharmacotherapy, Vol. 34, No. 12, 2000, pp. 1486.
[16]	A. A. El-Emam, S. H. Hansen, M. A. Moustafa, S. M. El-Ashry and D.T. El-Sherbiny, “Determination of Lisi- nopril in Dosage Forms and Spiked Human Plasma through Derivatization with 7-Chloro-4-nitrobenzo-2- oxa-1,3-diazole (NBD-Cl) Followed by Spectrophotome- try or HPLC with Fluorimetric Detection,” Journal of Pharmaceutical and Bio-medical Analysis, Vol. 34, No. 1, 2004, pp. 35-44. doi:10.1016/j.japna.2003.08.021
[17]	S. Olcay and E. Lale, “An HPLC Method for the Determination of Lisinopril in Human Plasma and Urine with Fluorescence Detection,” Journal of Chromatography B, Vol. 809, No. 1, 2004, pp. 159-165. doi:10.1016/j.jchromb.2004.06.014
[18]	N. Sultana, M. S. Arayne and S. Naveed, “Validated Method for the Simultaneous Determination of Lisinopril, Pravastatin, Atorvastatin and Rosuvastatin in API, Formulations and Human Serum by RP-HPLC,” Chinese Journal of Chemistry, Vol. 29, No. 6, 2011, pp. 1216- 1220. doi:10.1002/cjoc.201190226