Abstract
A simple, rapid, isocratic, high-performance liquid chromatography (HPLC) method has been developed for the first time for simultaneous determination of Metformin and ACE inhibitors (lisinopril, captopril, enalapril, and its degradable product) in bulk drugs, pharmaceutical products and in human serum. The separation was performed on a Purospher® Star RP-18 endcapped (250 mm × 4.6 mm id) column using methanol–water as mobile phase 50:50 (v/v) and 60:40 (v/v) as diluent. The pH of mobile phase was adjusted to 3.2 with ortho-phosphoric acid, flow rate was adjusted to 1 mLmin−1 at room temperature (25 °C) and analytes peaks were observed using UV detector at 218 nm. The retention times and LOD of lisinopril, enalapril, enalapril diketopiperazine, and captopril were 2.24, 2.63, 3.82, 4.28, and 4.78 min and were 0.028, 0.044, 0.20, 0.016, and 0.145 μgmL−1 respectively. The method was validated according to ICH guidelines. The linearity of the method was studied over the concentration range of 5–50 μgmL−1 for metformin and 2.5–250 μgmL−1 for the ACE inhibitors, where it demonstrated good linearity with r = 0.9998, 0.9979, 0.9997, and 0.9987 (n = 6), respectively. The developed method was successfully applied to quantitate metformin, lisinopril, captopril, and enalapril in pharmaceutical formulations and human serum.
Similar content being viewed by others
References
Al-Momani IF (2001) Determination of Hydrochlorothiazide and Enalapril Maleate in Tablet Formulations by Reversed-Phase HPLC. Turk J Chem 25(1):49–54
Amini M, Zarghi A, Vatanpour H (1999) Sensitive high-performance liquid chromatographic method for determination of captopril in plasma. Pharm Acta Helv 73(6):303–306
Anzenbacherová E et al (2001) Determination of enzyme (angiotensin convertase) inhibitors based on enzymatic reaction followed by HPLC. J Pharm Biomed Anal 24(5–6):1151–1156
Arayne MS, Sultana N, Zuberi MH, Siddiqui FA (2009) Spectrophotometric quantitation of metformin in bulk drug and pharmaceutical formulations using multivariate technique. Indian J Pharm Sci 71:331–335
Arayne MS, Sultana N, Zuberi MH, Siddiqui FA (2010) Simultaneous determination of metformin, cimetidine, famotidine and ranitidine in Human Serum and Dosage Formulations Using HPLC with a UV Detecton. J Chromatogr Sci 48(9):721–725
Bahmaei M et al (1997) Determination of captopril in human serum by high performance liquid chromatography using solid-phase extraction. J Pharm Biomed Anal 15(8):1181–1186
Cocolas GH, Delgado JN, Remers WA (1998) Textbook of organic medicinal and pharmaceutical chemistry, 10th edn. Lippincott-Raven, Philadelphia, pp 603–607
Dinç E et al (2005) A new application of chemometric techniques to HPLC data for the simultaneous analysis of a two-component mixture. J Liq Chromatogr Relat Technol 28(14):2179–2194
Green JM (1996) A practical guide to analytical method validation. Anal Chem 68:305A–309A
ICH Guideline (2005) Validation of analytical procedures: Text and Methodology
Hillaert S, Bossche WV (1999) Determination of captopril and its degradation products by capillary electrophoresis. J Pharm Biomed Anal 21(1):65–73
Huang T et al (2006) Simultaneous determination of captopril and hydrochlorothiazide in human plasma by reverse-phase HPLC from linear gradient elution. J Pharm Biomed Anal 41(2):644–648
Lancaster SG, Todd PA (1988) Lisinopril. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use in hypertension and congestive heart failure. Drugs 35(6):646–669
Medicines E (2007) WHO Model List of Essential Medicines. WHO Medicines web: http://www.who.int/medicines/publications/EML, p 15
Najma S, Arayne MS, Shafi N, Siddiqui FA (2011) Development and validation of new assay method for the simultaneous analysis of diltiazem, metformin, pioglitazone and rosiglitazone by RP-HPLC and its applications in pharmaceuticals and human serum. J Chromatogr Sci 49(10):774–779
Pasquale DP et al (1997) Early captopril treatment reduces plasma endothelin concentrations in the acute and subacute phases of myocardial infarction: a pilot study. J Cardiovasc Pharm 29(2):202–208
Pharmacopoeia European (2001) Council of Europe. Strasbourg, France
Sagirli O, Ersoy L (2004) An HPLC method for the determination of lisinopril in human plasma and urine with fluorescence detection. J Chromatogr B Anal Technol Biomed Life Sci 809(1):159–165
Shimada K, Tanaka M, Nambara T (1982) Determination of captopril in human blood by high-performance liquid chromatography with electrochemical detection. J Chromatogr 227(2):445–451
Tajerzadeh H, Hamidi M (2001) A simple HPLC method for quantitation of enalaprilat. J Pharm Biomed Anal 24(4):675–680
United States Pharmacopoeia (2006) Rockville
Vaughan DE et al (1997) Effects of ramipril on plasma fibrinolytic balance in patients with acute anterior myocardial infarction. Circulation 96(2):442–447
Wong Y, Charles BG (1995) Determination of the angiotensin-converting enzyme inhibitor lisinopril in urine using solid-phase extraction and reversed-phase high-performance liquid chromatography. J Chromatogr B 673(2):306–310
Author information
Authors and Affiliations
Corresponding author
Rights and permissions
About this article
Cite this article
Arayne, M.S., Sultana, N., Zuberi, M.H. et al. Simultaneous determination of metformin, captopril, lisinopril, and enalapril by RP-HPLC: its applications in dosage formulations and in human serum. Med Chem Res 22, 5717–5722 (2013). https://doi.org/10.1007/s00044-013-0501-z
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00044-013-0501-z