Optimisation and validation of liquid chromatographic and partial least-squares-1 methods for simultaneous determination of enalapril maleate and nitrendipine in pharmaceutical preparations
Abstract
Simultaneous determination of enalapril maleate (ENA) and nitrendipine (NIT) in pharmaceutical preparations was performed using liquid chromatography (LC) and the partial least-squares-1 (PLS-1) method. In LC, the separation was achieved on a C8 column and the optimum mobile phase for good separation in a gradient elution programme was found to be acetonitrile-water (φ r = 81: 19) and optimum flow-rate, temperature, injection volume, and detection wavelength were set at 1.0 mL min−1, 25°C, 10 μL, and 210 nm, respectively. Dienogest was selected as an internal standard. In the spectrophotometry, a PLS-1 chemometric method was used. The absorbance data matrix related to the concentration data matrix was established by measurement of absorbances in their zero order spectra with an increment of Δλ = 1 nm in the 220–290 nm range for ENA and with Δλ = 1 nm in the 230–290 nm range for NIT in the PLS-1 method. Following this step, calibration was established by using this data matrix to predict the unknown concentrations of ENA and NIT in their binary mixture. These optimised methods were validated and successfully applied to a pharmaceutical preparation in tablet form and the results were subjected to comparison.
[1] Brereton, R. G. (2002) Chemometrics: Data analysis for the laboratory and chemical plant. New York, NY, USA: Wiley. 10.1002/0470863242Suche in Google Scholar
[2] Çaǧlayan, M. G., Palabiyik, I. M., & Onur, F. (2010). Development and validation of spectrophotometric and highperformance column liquid chromatographic methods for the simultaneous determination of dienogest and estradiol valerate in pharmaceutical preparations. Journal of AOAC International, 93, 862–868. DOI: 10.5555/jaoi.93.3.862. Suche in Google Scholar
[3] Goa, K. L., & Sorkin, E. M. (1987). Nitrendipine. A review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy in the treatment of hypertension. Drugs, 33, 123–155. http://dx.doi.org/10.2165/00003495-198733020-0000310.2165/00003495-198733020-00003Suche in Google Scholar PubMed
[4] International Conference on Harmonisation (2003). International Conference on Harmonisation of technical requirements for registration of pharmaceuticals for human use. Geneva, Switzerland: ICH. Suche in Google Scholar
[5] Kang, G., Lee, K., Park, H., Lee, J., Jung, Y., Kim, K., Son, B., & Park, H. (2010). Quantitative analysis of mixed hydrofluoric and nitric acids using Raman spectroscopy with partial least squares regression. Talanta, 81, 1413–1417. DOI: 10.1016/j.talanta.2010.02.045. http://dx.doi.org/10.1016/j.talanta.2010.02.04510.1016/j.talanta.2010.02.045Suche in Google Scholar PubMed
[6] Karacan, E., Çaǧlayan, M. G., Palabiyik, I. M., & Onur, F. (2011). Liquid chromatographic and spectrophotometric determination of diflucortolone valerate and isoconazole nitrate in creams. Journal of AOAC International, 94, 128–135. DOI: 10.5555/jaoi.94.1.128. Suche in Google Scholar
[7] Lamontagne, D., Nadeau, R., & Adam, A. (1995). Effect of enalaprilat on bradykinin and des-Arg9-bradykinin release following reperfusion of the ischaemic rat heart. British Journal of Pharmacology, 115, 476–478. 10.1111/j.1476-5381.1995.tb16357.xSuche in Google Scholar PubMed PubMed Central
[8] Palabiyik, I. M., Yardimci, C., Onur, F., & Özaltin, N. (2008). Simultaneous spectrophotometric determination of ezetimibe and simvastatin in pharmaceutical preparations using chemometric techniques. Química Nova, 31, 1121–1125. DOI: 10.1590/S0100-40422008000500035. Suche in Google Scholar
[9] Santos, E. L., de Picoli Souza, K., Bianci Guimarães, P., Castellani Gomes Reis, F., Affonso Silva, S. M., Costa-Neto, C. M., Luz, J., & Pesquero, J. B. (2008). Effect of angiotensin converting enzyme inhibitor enalapril on body weight and composition in young rats. International Immunopharmacology, 8, 247–253. DOI: 10.1016/j.intimp.2007.07.021. http://dx.doi.org/10.1016/j.intimp.2007.07.02110.1016/j.intimp.2007.07.021Suche in Google Scholar PubMed
[10] Sokullu, E., Palabıyık, I. M., Onur, F., & Boyacı, I. H. (2010). Chemometric methods for simultaneous quantification of lactic, malic and fumaric acids. Engineering in Life Sciences, 10(4), 297–303. DOI: 10.1002/elsc.200900080. http://dx.doi.org/10.1002/elsc.20090008010.1002/elsc.200900080Suche in Google Scholar
© 2011 Institute of Chemistry, Slovak Academy of Sciences
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Artikel in diesem Heft
- Determination of four trace preservatives in street food by ionic liquid-based dispersive liquid-liquid micro-extraction
- Optimisation and validation of liquid chromatographic and partial least-squares-1 methods for simultaneous determination of enalapril maleate and nitrendipine in pharmaceutical preparations
- Chemiluminescence parameters of peroxynitrous acid in the presence of short-chain alcohols and Ru(bpy)32+
- Investigation of multi-layered silicate ceramics using laser ablation optical emission spectrometry, laser ablation inductively coupled plasma mass spectrometry, and electron microprobe analysis
- Simultaneous analysis of three catecholamines by a kinetic procedure: comparison of prediction performance of several different multivariate calibrations
- Enzymatic saccharification of cellulose in aqueous-ionic liquid 1-ethyl-3-methylimidazolium dimethylphosphate-DMSO media
- Statistical and evolutionary optimisation of operating conditions for enhanced production of fungal l-asparaginase
- Extraction of phytosterols from tall oil soap using selected organic solvents
- Dynamic simulations of waste water treatment plant operation
- Influence of recycling and temperature on the swelling ability of paper
- Zirconium(IV) 4-sulphophenylethyliminobismethylphosphonate as an efficient and reusable catalyst for one-pot synthesis of 3,4-dihydropyrimidones under solvent-free conditions
- Toxicity reduction of 2-(5-nitrofuryl)acrylic acid following Fenton reaction treatment
- Synthesis and characterisation of alkaline earth-iron(III) double hydroxides
- Effect of cyclodextrins on pH-induced conformational transition of poly(methacrylic acid)
- Polyamine-substituted epoxy-grafted silica for aqueous metal recovery
- Helical silica nanotubes: Nanofabrication architecture, transfer of helix and chirality to silica nanotubes
- DFT calculations on the Friedel-Crafts benzylation of 1,4-dimethoxybenzene using ZnCl2 impregnated montmorillonite K10 — inversion of relative selectivities and reactivities of aryl halides
- Facile synthesis of 3-aryl-1-((4-aryl-1,2,3-selenadiazol-5-yl)sulfanyl)isoquinolines
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