Development and validation of a reversed-phase HPLC method for the determination of lisinopril and gliclazide in pharmaceuticals

The aim of the present study was to develop and validate a High-Performance Liquid Chromatography (HPLC) method for the determination of lisinopril and gliclazide. The method was developed on Zorbax C8 analytical column (4.6x250 mm; 5µm) by isocratic elution with a flow rate of 1.0 mL/min and injection volume of 25 µl. The mobile phase composition was methanol:water (65:35 v/v, pH adjusted to 3.0 triethylamineorthophosphoric acid buffer) and the retention time was found to be 2.883 and 7.456 min for lisinopril and gliclazide, respectively. The developed method was found to be linear in the concentration range of 5-20 µg/mL for lisinopril and 15-60 µg/mL for gliclazide. The method was validated for linearity, accuracy, precision, LOD and LOQ. This developed procedure was succesfully applied conveniently for the analysis of lisinopril and gliclazide in pharmaceutical preparations.

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Bernard MYC, Chao L. Diabetes and hypertension: Is there acommon metabolic pathway? Curr Atheroscler Rep 2012;14:160-6.

Bakris LG, MD, Sowers JR. ASH position paper: Treatmentof hypertension in patients with diabetes-an update. J ClinHypertens 2008; 10:707-13.

Gleissner CA, Galkina E, Nadler JL, Ley K. Mechanisms bywhich diabetes increases cardiovascular disease. Drug DiscovToday Dis Mech 2007; 4: 131-40.

Zhou M, Wang A, Yu H. Link between insulin resistanceand hypertension: What is the evidence from evolutionarybiology? Diabetol Metab Syndr 2014; 6: 12.

Palmer KJ, Brogden RN. Gliclazide. An update of itspharmacological properties and therapeutic efficacy in noninsulin-dependent diabetes mellitus. Drugs 1993; 46:92-125.

Sarkar A, Tiwari A, Bhasin PS, Mitra M. Pharmacological andpharmaceutical profile of gliclazide: A review. JAPHAC 2011;1:11-9.

Naidoo P, Virendra R, Layla M. Effects of gliclazide doseescalation on postprandial hyperglycemia in type 2 diabetesmellitus: A prospective, open-label, case-controlled, doseescalationstudy. Curr Ther Res Clin Exp 2006; 67: 81-102.

Jennings PE, Scott NA, Saniabadi AR, Belch JJ. Effects ofgliclazide on platelet reactivity and free radicals in type IIdiabetic patients: clinical assessment. Metabolism 1992; 41:36-9.

Pagano PJ, Griswold MC, Ravel D, Cohen RA. Vascular actionof the hypoglycaemic agent gliclazide in diabetic rabbits.Diabetologia 1998; 41: 9-15.

Goa KL, Haria M, Wilde MI. Lisinopril. A review of itspharmacology and use in the management of the complicationsof diabetes mellitus. Drugs 1997; 53: 1081-105.

Goa KL, Balfour JA, Zuanetti G. Lisinopril. A review of itspharmacology and clinical efficacy in the early managementof acute myocardial infarction. Drugs 1996; 52: 564-88.

El-Gindy A, Ashour A, Abdel-Fattah L, Shabana MM.Spectrophotometric, septrofluorimetric and LC determinationof lisinopril. J Pharm Biomed Anal 2001; 25: 913-22.

Kousoulos C, Tsatsou G, Dotsikas Y, Loukas YL. Developmentof a rapid liquid chromatography tandem mass spectrometrymethod for the determination of lisinopril, applicable for abioequivalence study, employing a 96-well format solid phaseextraction protocol. Anal Chim Acta 2005; 551: 177-83.

El-Emam AA, Honore Hansen S, Moustafa MA, El-AshrySM, El-Sherbiny DT. Determination of lisinopril in dosageforms and spiked human plasma through derivatization with7-chloro-4-nitrobenzo-2-oxa-1,3-diazole (NBD-Cl) followedby spectrophotometry or HPLC with fluorimetric detection.J Pharm Biomed Anal 2004; 34: 35-44.

Paraskevas G, Atta-Politou J, Koupparis M. Spectrophotometricdetermination of lisinopril in tablets using 1-fluoro-2,4-dinitrobenzene reagent. J Pharm Biomed Anal 2002; 29: 865-72.

Ozer D, Şenel H. Determination of lisinopril frompharmaceutical preparations by derivative UVspectrophotometry. J Pharm Biomed Anal 1999; 21: 691-5.

Rouini M, Mohajer A, Tahami M. A simple and sensitiveHPLC method for determination of gliclazide in humanserum. J Chromatogr B 2003; 785: 383-6.

El-Enany N. Spectrophotometric determination of gliclazidein pharmaceuticals and biological fluids through ternarycomplex formation with eosin and palladium (II). Il Farmaco2004; 59: 63-9.

Kuoa C, Wua S. High-performance liquid chromatographywith electrochemical detection for analysis of gliclazide inplasma. J Chromatogr A 2005; 1088: 131-5.

Singh P, Kumar R, Sıngh H. Application of UVspectrophotometric method for analysis of gliclazide inpharmaceutical dosage forms. Int J Pharm Pharm Sci 2011;3: 259-60.

ICH Q2 (R1), “Validation of Analytical Procedures: Text and Methodology,” 2005.
Marmara Pharmaceutical Journal-Cover
  • ISSN: 1309-0801
  • Yayın Aralığı: Yılda 6 Sayı
  • Başlangıç: 1985
  • Yayıncı: Marmara Üniversitesi
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