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Rapid, sensitive and accurate method for determination of Lafutidine hydrochloride in human plasma by RP-HPLC system

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Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
Simple and rapid reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated using Phenomenex Gemini c18 (4.6 x 250 mm, 5 μ) reverse phase column for the determination of LAF in human plasma, Solid Phase Extraction (SPE) technique was used for the extraction of analyte, detection was carried out by Photo Diode Array detector at 216 nm. Chromatographic resolution of the LAF was achieved within 4.6 min by using mobile phase Methanol and 5 mM Di-Potassium Hydrogen Phosphate Buffer (pH 9.5) (80:20, v/v), flow rate was 1.0 mL/min. Calibration curve was linear with correlation coefficient of 0.9996 in the range of 50-1000 ng/mL, Limit of Detection (LOD) and Limit of Quantitation (LOQ) were 10 ng/mL and 30 ng/mL respectively, intra and inter-day deviations were lower than 3.92 % and 3.98 % respectively. The overall mean recovery of LAF was 94.57 %. No any endogenous constituents were found to interfere at retention time of the analyte. This new RP-HPLC method was successfully validated and may be applied to conduct bioavailability & bioequivalence studies of LAF.
Słowa kluczowe
Rocznik
Tom
Strony
9--20
Opis fizyczny
Bibliogr. 16 poz., rys., tab.
Twórcy
  • Department of Chemistry, Saurashtra University, Rajkot - 36005, India
autor
  • Department of Chemistry, Saurashtra University, Rajkot - 36005, India
Bibliografia
  • [1] The Merck Index, 2001. An encyclopedia of Chemicals, Drugs and Biologicals, Thirteenth Edition, Merck Research Laboratories division of Merck and Co., Inc. Whitehouse Station, NJ, USA, 1263.2., 5362: 957.
  • [2] T. Shimatani, M. Inoue, T. Kuroiwa, J. Xu, M. Nakamura, Digestive Diseases Science 51(2006) 114-20.
  • [3] H. Sato, K. Kawashima, M. Yuki, H. Kazumori, M. Rumi, C. Ortega, The Journal of Laboratory and Clinical Medicine 141 (2003) 102-105.
  • [4] H. Toh, T. Aito, M. Akeyama, Biological Pharmaceutical Bulletin 25 (2002) 379-382.
  • [5] H. Ajioka, N. Matsuura, H. Miyake, Inflammopharmacology 10 (2002) 483-493.
  • [6] K. Nagahama, M. Yamato, S. Kato, K. Takeuchi, Journal of Pharmacological Sciences 93(2003) 55-61.
  • [7] H. Iida, M. Inamori, Y. Nozaki, H. Endo, K. Hosono, T. Akiyama, BMC Gastroenterology 9 (2009) 52.
  • [8] L. Wu, Z. Zhang, Y. Tian, W. Li, F. Xu, Y. Chen, Journal of Mass Spectrometry 40 (2005) 1637-1643.
  • [9] W. Chen, Y. Liang, H. Li, Y. Xiong, X. Liu, G. Wang, Journal of Pharmaceutical and Biomedical Analysis 41 (2006) 256-60.
  • [10] K. Jadhav, D. Dhamecha, S. Ghadlinge, G. Asnani, M. Patil, ISRN Analytical Chemistry (2012) 1-4.
  • [11] M. Sumithra, P. Sundaram, K. Srinivasulu, International Journal of Chemistry 3 (2011) 1403-1407.
  • [12] M. Jagadeeswaran, N. Gopal, B. Jayakar, T. Sivakumar, Global Journal of Pharmacology 6 (2012) 60-64.
  • [13] R. Parekh, P. Patel, C. Patel, H. Patel, International Journal of Drug Development & Research 4 (2012) 325-329.
  • [14] P. Vekariya, H. Joshi, ISRN Spectroscopy (2013) 1-6.
  • [15] G. Pandya, H. Joshi, Der Pharmacia Sinica 4 (2013) 145-152.
  • [16] US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry, Bioanalytical Method Validation, May 2001.
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-b107b57b-6379-4fd1-ab36-255b81733480
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