Journal : Acta Chromatographica
Article : Comparative study of RP-HPLC versus TLC-spectrodensitometric methods applied for binary mixtures of fluoroquinolones and corticosteroids

Authors :
Fatemi, M. H.
University of Mazandaran Faculty of Chemistry Babolsar Iran,
Hadjmohammadi, M. R.
University of Mazandaran Faculty of Chemistry Babolsar Iran, hdjmr@umz.ac.ir,
Shakeri, P.
University of Mazandaran Faculty of Chemistry Babolsar Iran,
Bhushan, R.
Indian Institute of Technology Roorkee Department of Chemistry Roorkee 247667 India, rbushfcy@iitr.ernet.in,
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, saji_thomas@jubl.com,
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, drsarahsalah@gmail.com,
Abstract : Reversed phase high-performance liquid chromatography (RP-HPLC) and thin-layer chromatography (TLC)-spectrodensitometric methods have been developed and validated for the separation and quantitation of two binary mixtures: Ofloxacin (OFX) and dexamethasone (DXM) in eye preparation; ciprofloxacin hydrochloride (CIP) and hydrocortisone (HYD) in ear preparation. The linearity ranges of RP-HPLC methods were found to be (2.5–45 μg mL-1) for OFX, (2.5–50 μg mL-1) for DXM and (1–8 μg mL-1) for both CIP and HYD. The percentage recoveries/relative standard deviation (RSD) were found to be 100.36/1.38, 100.13/1.49, 99.98/0.61 and 100.28/1.27, respectively. The linearity ranges of TLC-spectrodensitometric methods were found to be (0.5–2 μg band-1), (0.5–3.5 μg band-1), (0.2–1.6 μg band-1), and (0.6–2 μg band-1for OFX, DXM, CIP, and HYD, respectively. The percentage recoveries/RSD were found to be 99.98/1.06, 99.93/1.18, 99.74/1.27, and 99.94/1.54, respectively. A comparative study was conducted to show the advantages of the proposed methods which showed that the TLC-spectrodensitometric methods were simpler, more sensitive, and economic, while RP-HPLC methods were more precise and robust. The methods were validated in compliance with the ICH guidelines and were successfully applied for determination of the selected drugs in their laboratory-prepared mixtures and commercial dosage forms.

Keywords : ofloxacin, dexamethasone, ciprofloxacin hydrochloride, hydrocortisone, HPLC,
Publishing house : University of Silesia in Katowice
Publication date : 2014
Number : Vol. 26, no. 3
Page : 439 – 456

Bibliography
: 1 Sweetman, SC (ed.) Martindale: The Complete Drug Reference. Pharmaceutical Press, London, 2005
2 British Pharmacopoeia, The Stationery Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA)-© Crown Copyright, 2009
3 A.I. Drakopoulos, and P.C. Ioannou, Anal. Chim. Acta, 354, 197–204 (1997)
4 G.H. Ragab, and A.S. Amin, Spectrochim. Acta, Part A, 60, 973–978 (2004)
5 H. Hopkala and D. Kowalczuk, Acta Pol. Pharm., 57, 3–13 (2000)
6 J.D. Smet, K. Bousserya, K. Colpaertb, P. De Suttera, P. De Paepec, J. Decruyenaereb, and J.V. Bocxlaera, J. Chromatogr., B, 877, 961–967 (2009)
7 V.F. Samanidou, C. Demetriou, and I.N. Papadoyannis, Anal. Bioanal. Chem., 375, 623–629 (2003)
8 R. Singh, M. Maithani, S.K. Saraf, S. Saraf, and R.C. Gupta, Eurasian J. Anal. Chem. 4, 161–167, (2009)
9 Y.L. Feng, and C. Dong C, J. Chromatogr. Sci., 42, 474–477 (2004)
10 S. Han-wen, H. Pan, L. Yun-kai, and L. Shu-xuan, J. Chromatogr., B, 852, 145–151 (2007)
11 F.A. El-Yazbi, H.H. Hammud, and S.A. Assi, Anal. Chim. Acta, 580, 39–46 (2006)
12 J.M. Lemus Gallego and J. P. Arroyo, Anal. Chim. Acta, 460, 85–97 (2002)
13 Q. Chen, D. Zielinski, J. Chen, A. Koski, D. Werst, and S. Nowak, J. Pharm. Biomed. Anal., 48, 732–738 (2008)
14 Y. Xiong, K.P. Xiao, and A.M. Rustum, J. Pharm. Biomed. Anal., 49, 646–654 (2009)
15 E. Grippa, L. Santini, G. Castellano, M.T. Gatto, M.G. Leone, and L. Saso, J. Chromatogr., B, 738, 17–25 (2000)
16 M. Pendela, G. Kahsay, I. Baekelandt, A.V. Schepdael, and E. Adams, J. Pharm. Biomed. Anal., 56, 641–644 (2011)
17 V. Baeyens, E. Varesio, J.L. Veuthey, and R. Gurny, J. Chromatogr., B, 692, 222–226 (1997)
18 H. Sirén, T. Seppänen-Laakso, M. Orešič, J. Chromatogr., B, 871, 375–382 (2008)
19 T. Ruiwei, M. Mingxiu, and L. Genghao, West China J. Pharm. Sci., 4, 45–46 (1999)
20 L. Wei, G. Hua, and Z. Fantao, China Pharm., 10, 1 (2005)
21 K. Sireesha, and K. Prakash, Int. J. Pharm. Pharm. Sci., 4, 415–418 (2012)
22 W. Chun-Lan, L. Shi-Cai, and L. Lan-Ju, Chinese J. Pharm., 1 (2004)
23 L. Li, Determination of Ciprofloxacin and Hydrocortisone in Compound Ciprofloxacin Ear Drops by HPLC. Chinese Pharmaceutical Affairs, 3 (2008)
24 United States Pharmacopoeia Commission, United States Pharmacopeia-National formulary. United States Pharmacopeial Inc., 2280–2282. 2004
25 V.P. Ranea, and D.B. Shindea, Eurasian J. Anal. Chem., 4, 304–310 (2009)
26 A.S. Amin, H.A. Dessouki, and IA Agwa, Arab J. Chem., 4, 249–257 (2011)
27 K.S. Khandagle, SV. Gandhi, P.B. Deshpande, and N.V. Gaikwad, Int. J. Pharm. Pharm. Sci., 3(1), 46–48 (2011)
28 N.E. Wagieh, M.A. Hegazy, M. Abdelkawy, and E.A. Abdelaleem, Talanta, 80, 2007–2015 (2010)
29 Y.S. El-Saharty, N.A. El-Ragehy, H.M. Abdel-Monem, and M.I. Abdel-Kawy, JAR, 1, 71–78 (2010)
30 European Egyptian Pharmaceutical Industries (EEPI) Quality Control Department, Test Method for Determination of Ciprocort Ear Drops
31 International Conference on Harmonization (ICH), Q2B Validation of Analytical Procedures: Methodology, 62, US FDA, Federal Register, 1997
DOI :
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. ,Saleh, S. S. , Comparative study of RP-HPLC versus TLC-spectrodensitometric methods applied for binary mixtures of fluoroquinolones and corticosteroids. Acta Chromatographica Vol. 26, no. 3/2014
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