

Optimization and validation of a new chromatographic method for the assay of veterinary formulation
Hany Hunter Monir (1)





(1) Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, 11562, Cairo, Egypt
(2) Analytical Chemistry Department, Faculty of Pharmacy, Ahram Canadian University, 12566, 6th of October City, Egypt
(3) Analytical Chemistry Department, Faculty of Pharmacy, Ahram Canadian University, 12566, 6th of October City, Egypt
(4) Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, 11562, Cairo, Egypt
(5) Senior Researcher Poultry Disease Reference Laboratory, Veterinary Quality Control on Poultry Production, 12211, Cairo, Egypt
(*) Corresponding Author
Received: 14 Apr 2019 | Revised: 03 Jun 2019 | Accepted: 14 Jun 2019 | Published: 30 Sep 2019 | Issue Date: September 2019
Abstract
New, validated and accurate reversed phase HPLC method with UV detection has been established for simultaneous determination of a veterinary binary mixture of doxycycline hydrochloride (DOX) and tylosin tartrate (TYT). The stationary phase was ACE- 126-2546 AQ C-18 (250 × 4.6 mm i.d., 5 μm particle size) column at 25 °C, in an isocratic mode, using mobile phase containing a mixture of methanol: acetonitrile: distilled water in the ratio of 60:20:20 (v:v:v), with 0.01% trichloroacetic acid at the flow rate of 0.8 mL/min and UV detection was performed at 270 nm. The retention times were 4.02±0.01 and 5.62±0.01 mins for DOX and TYT, respectively. Selective determination of the cited veterinary drugs has been developed in their formulation. The method was found to be linear over 1-50 µg/mL for DOX and TYT with mean percentage recoveries 99.62±1.220 and 100.09±1.104%. The method was proven to be accurate, precise and specific. The obtained results were statistically compared with those of the official and reported methods; using Student’s t test, F test and one-way ANOVA, showing no significant difference with high accuracy. Specificity of the applied method was assessed by analysing the laboratory-prepared mixtures and their combined dosage form. The developed method was confirmed according to ICH guidelines. The validated method can be considered as alternative and basic method for the routine determination of this fixed dose combination with minimum sample preparation.
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DOI: 10.5155/eurjchem.10.3.218-223.1880
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Funding information
Pharma Swede Veterinary Company, Egypt.
Citations
[1]. Adel M. Michael, Hayam M. Lotfy, Christine K. Nessim
Greenness profile and whiteness assessment of the stability-indicating HPLC method for the assay of levetiracetam
Microchemical Journal 190, 108669, 2023
DOI: 10.1016/j.microc.2023.108669

References
[1]. University of Michigan Health System Peptic Ulcer Disease. Accessed June 01, 2019. at: http://www.med.umich.edu/1info/FHP/ practiceguides/newpud/pud.pdf
[2]. British Pharmacopoeia, Her Majesty's Stationery Office, London, vol. I & II (P. 552) and vol. V (P. 6), 2013.
[3]. Sweetman, S. C., Martindale, The complete drug reference, 33rd ed. Pharmaceutical Press, London, 2002.
[4]. Watanabe, W.; Harter, T.; Bergamaschi, B. J. Environ. Quality 2008, 37, 78-85.
https://doi.org/10.2134/jeq2007.0371
[5]. Sun, P.; Barmaz, D.; Cabrera, M.; Pavlostathis and Huang, Ch. J. Chromatogr. A 2013, 1312, 10-17.
https://doi.org/10.1016/j.chroma.2013.08.044
[6]. Lotfy, H. M.; Maha, A. H.; Tawakkol, S.; Mohamed, E. H. Spectrochim. Acta A 2016, 153, 321-332.
https://doi.org/10.1016/j.saa.2015.07.106
[7]. Kogawa, A. C.; Salgado, H. R. N. World Res. J. Pharm. Res. 2013, 1(2), 021-024.
[8]. Lopez, P. J. L.; Martinez, C. J. J. Pharma. Biomed. Anal. 1993, 11, 1093-1098.
[9]. Salinas, F.; Berzas Nevado, J. J.; Espinosa, A. Analyst 1989, 114, 1141-1145.
https://doi.org/10.1039/an9891401141
[10]. Mahrous, M. S.; Abdel-Khalek, M. M. Talanta 1984, 31, 289-291.
https://doi.org/10.1016/0039-9140(84)80281-7
[11]. Attia, M. S.; Mahmoud, W. H.; Ramsis, M. N.; Khalil, L. H.; Othman, A. M.; Hashem, S. G.; Mostafa, M. J. Fluores. 2011, 21(4), 1739-1748.
https://doi.org/10.1007/s10895-011-0869-4
[12]. Van den Bogert, C.; Kroon, A. M. J. Pharm. Sci. 1981, 70, 186-189.
https://doi.org/10.1002/jps.2600700218
[13]. Salinas, F.; Pena, A. M.; Duran, M. I. Anal. Lett. 1990, 23, 863-876.
https://doi.org/10.1080/00032719008052487
[14]. Croubels, S.; Vermeersch, H.; Backeer, P.; Santos, M. D. F.; Remon, J. P.; Van Peteyhem, C. J. Chromatogr. B 1998, 708, 145-152.
https://doi.org/10.1016/S0378-4347(97)00644-0
[15]. Klimes, J. D. M. J. Chromatogr. A 1999, 846, 181-184.
https://doi.org/10.1016/S0021-9673(99)00148-X
[16]. Gajda, A.; Posyniak, A.; Pietruszka, K. Bull. Vet. Inst. Pulawy. 2008, 52, 417-420.
[17]. Gajda, A.; Posyniak, A.; Zmudzki, J.; Tomczyk, G. J. Chromatogr. B 2013, 928, 113-120.
https://doi.org/10.1016/j.jchromb.2013.03.011
[18]. Pavagada, J. R.; Kanakapura, B.; Kalsang, T.; Kanakapura, B. V.; Hosakere, D. R. J. Pre-Clin. Clin. Res. 2010, 4(2), 101-107.
[19]. Ruz, N.; Zabala, M.; Kramer, M. G.; Campanero, M. A.; Dios-Vieitez, M. C.; Blanco-Prieto, M. J. J. Chromatogr. 2004, 1031, 295-301.
https://doi.org/10.1016/j.chroma.2003.12.028
[20]. Cinquina, A. L.; Longo, F.; Anastasi, G.; Giannetti, L.; Cozzani, R. J. Chromatogr. A 2003, 987, 227-33.
https://doi.org/10.1016/S0021-9673(02)01446-2
[21]. Gastearena, I.; Dios-Vieitez, M. C.; Segura, E.; Goni, M. M.; Renedo, M. J.; Fos, D. Chromatographia 1993, 35, 524-526.
https://doi.org/10.1007/BF02267911
[22]. Zarghi, A.; Kebriaeezadeh, A.; Ahmadkhaniha, R. Bull. Chim. Farm. 2001, 140, 112-114.
[23]. Shoukry, A. F.; Badawy, S. S. Microchem. J. 1987, 36, 107-112.
https://doi.org/10.1016/0026-265X(87)90142-1
[24]. Issa, Y. M.; Abdel-Fattah, H. M.; Abdel-Moniem, N. B. Int. J. Electrochem. Sci. 2013, 8, 9578-9592.
[25]. Vargas, A., BSc Thesis, Faculty of LʼEcole Nationale Supérieure des Industries Chimiques and Worcester Polytechnic Institute, Nancy, France, 1-88, 2011.
[26]. Ghanem, M.; Saleh, A. J. Appl. Pharm. Sci. 2015, 5(1), 094-098.
[27]. Pietron, W.; Cybulski, W.; Kos, K.; Mitura, A. Bull. Vet. Inst. Pulawy 2011, 55, 725-729.
[28]. Ahmed, M. B. M.; Sree, Y. H. A.; Abdel-Fattah, S. M.; Hassan, N. S.; Saad, M. M. E. J. Planar Chromat. 2013, 26(5), 409-416.
https://doi.org/10.1556/JPC.26.2013.5.4
[29]. Kotha, S.; Sunitha, N.; Manoharbabu, S.; Inter. J. Pharm. Anal. Res. 2014, 3(2), 214-221.
[30]. Stan, G.; Badea, I. A.; Hassan, Y. A. J. Chromatogr. Sci. 2016, 54(9), 1567-1572.
https://doi.org/10.1093/chromsci/bmw105
[31]. United States Pharmacopoeia Commission, United States pharmacopeia-National formulary. United States Pharmacopoeial Inc., 2280-2282, 2004.
[32]. International Conference on Harmonization (ICH), Q2 (R1): Validation of Analytical Procedures: Text and Methodology, US FDA, Federal Register, ICH, 2005.
[33]. Lotfy, H. M.; Fayez, Y. M.; Michael, A. M.; Nessim, C. K. Spectrochim. Acta A 2016, 155, 11-20.
https://doi.org/10.1016/j.saa.2015.10.033
[34]. Hegazy, M. A.; Lotfy, H. M.; Rezk, M. R.; Omran, Y. R. Spectrochim. Acta A 2015, 140, 600-613.
https://doi.org/10.1016/j.saa.2014.12.098
[35]. Michael, A. M.; Shalliker, R. A. Ana
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