Article : High-performance liquid chromatographic determination of montelukast sodium in human plasma: Application to bioequivalence study
Authors : Fatemi, M. H.University of Mazandaran Faculty of Chemistry Babolsar Iran, Hadjmohammadi, M. R.University of Mazandaran Faculty of Chemistry Babolsar Iran, firstname.lastname@example.org, Shakeri, P.University of Mazandaran Faculty of Chemistry Babolsar Iran, Bhushan, R.Indian Institute of Technology Roorkee Department of Chemistry Roorkee 247667 India, email@example.com, Lal, M.Indian Institute of Technology Roorkee Department of Chemistry Roorkee 247667 India, Thomas, S.Jubilant Life Sciences Ltd. Analytical Research Department R&D Centre, C-26, Sector-59 Noida Uttar Pradesh 201 301 India, firstname.lastname@example.org, Paul, S. K.Jubilant Life Sciences Ltd. Analytical Research Department R&D Centre, C-26, Sector-59 Noida Uttar Pradesh 201 301 India, Agarwal, A.Jubilant Life Sciences Ltd. Analytical Research Department R&D Centre, C-26, Sector-59 Noida Uttar Pradesh 201 301 India, Mathela, C. S.Kumaun University Department of Chemistry DSB Campus Nainital Uttarakhand 263 001 India, Elgizawy, S. M.Assuit University Analytical Chemistry Department, Faculty of Pharmacy 71515 Assuit Egypt, Hassan, N. Y.Cairo University Analytical Chemistry Department, Faculty of Pharmacy Kasr-El Aini Street 11562 Cairo Egypt, Lotfy, H. M.Cairo University Analytical Chemistry Department, Faculty of Pharmacy Kasr-El Aini Street 11562 Cairo Egypt, Saleh, S. S.October University for Modern Sciences and Arts (MSA) Analytical Chemistry Department, Faculty of Pharmacy 11787 6th October City Egypt, email@example.com, Shakya, A.Al-Ahliyya Amman University Faculty of Pharmacy and Medical Sciences PO Box 263 Amman 19328 Jordan, firstname.lastname@example.org, Arafat, T.Petra University Faculty of Pharmacy PO Box 961343 Amman Jordan, Hakooz, N. M.Zarqa University Faculty of Pharmacy Zarqa 13132 Jordan, Abuawwad, A. N.Jordan Center for Pharmaceutical Research PO Box 950435 Amman 11495 Jordan, Al-Hroub, H.Jordan Center for Pharmaceutical Research PO Box 950435 Amman 11495 Jordan, Melhim, M.Jordan Center for Pharmaceutical Research PO Box 950435 Amman 11495 Jordan,
Abstract : A simple, sensitive, and precise high-performance liquid chromatographic (HPLC) method for quantitation of montelukast in human plasma has been developed and validated. Commercially available candesartan cilexetil was used as an internal standard. After protein precipitation, montelukast and candesartan cilexetil (I.S.) in human plasma were analyzed using mobile phase containing 62% v/v acetonitrile and 38% v/v buffer (containing 1 mL L-1triethylamine as peak modifier, final pH adjusted to 2.5 with orthophosphoric acid). Chromatographic separation was achieved on a BDS Hypersil-C18 column (50 × 4.6 mm i.d., particle size 5 μm; Thermo Electron Corporation, USA) using isocratic elution at a flow rate of 1.5 mL min−1. The signals were monitored using a fluorescence detector set at 350 nm for excitation and 400 nm for emission. The total time for a chromatographic separation was ∼3 min. The validated quantitation ranges of this method were 5–300 ng mL-1with coefficients of variation between 1.75% and 9.38%. Mean recoveries were 91.8 ± 3.8%. The within- and between-batch precisions were 0.74–2.46% and 1.64–7.87%, respectively. The within- and between-batch relative errors (bias) were 0.14–3.3% and 0.08–4.6%, respectively. Stability of montelukast in plasma was >94.7%, with no evidence of degradation during sample processing and 30 days storage in a deep freezer at −70°C. This validated method is sensitive and simple with between-batch precision of <8% and successfully applied for the bioequivalence studies. The formulations were compared using the following pharmacokinetic parameters: AUC0−t, AUC0−∞, and Cmax. No statistically significant difference (p > 0.05) was observed between the logarithmically transformed AUC0−t, AUC0−∞, and Cmax values.
Publishing house : University of Silesia in Katowice
Publication date : 2014
Number : Vol. 26, no. 3
Page : 457 – 472
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Qute : Fatemi, M. H. ,Hadjmohammadi, M. R. ,Shakeri, P. ,Bhushan, R. ,Lal, M. ,Thomas, S. ,Paul, S. K. ,Agarwal, A. ,Mathela, C. S. ,Elgizawy, S. M. ,Hassan, N. Y. ,Lotfy, H. M. ,Saleh, S. S. ,Shakya, A. ,Arafat, T. ,Hakooz, N. M. ,Abuawwad, A. N. ,Al-Hroub, H. ,Melhim, M. ,Melhim, M. , High-performance liquid chromatographic determination of montelukast sodium in human plasma: Application to bioequivalence study. Acta Chromatographica Vol. 26, no. 3/2014