AJAC  Vol.3 No.4 , April 2012
New Method for Optimization and Simultaneous Determination of Sparfloxacin and Non Steroidal Anti-Inflammatory Drugs: Its In-Vitro Application
Abstract: A simple reversed phase HPLC method was developed and validated for the simultaneous determination of sparfloxacin (SPFX), diclofenac sodium, meloxicam, ibuprofen, flurbiprofen, naproxen and mefenemic acid in a relatively short time with high linearity in bulk material, pharmaceutical formulations and human serum. Purospher STAR C18 (250 × 4.6 mm, 5 μm) column was utilized with mobile phase, methanol and water (90:10, v/v pH 2.70 adjusted by phosphoric acid), was delivered at a flow rate of 1.5 mL.min–1. Eluent was monitored using UV detector at 240 nm. The proposed method is specific, accurate (98.42% - 102.75%), precise (intra-day and inter-day variation 0.011% - 1.85%) and linear (R2 > 0.999) with in the desired range 0.15 - 40 μg.mL–1 and the detection and quantification limit was 1.19E+08 – 0.150 μg.mL–1 and 3.62E+08 – 0.4574 μg.mL–1 respectively for SPFX and NSAIDs. The analysis of variance (ANOVA) and student’s t-test were applied to verify the results. The anticipated method is applicable to routine analysis of SPFX and NSAIDs in pharmaceutical formulations as well as in human serum samples. It has also applied on interaction of SPFX with NSAIDs.
Cite this paper: S. Gul, N. Sultana, M. Saeed Arayne, S. Shamim and M. Akhtar, "New Method for Optimization and Simultaneous Determination of Sparfloxacin and Non Steroidal Anti-Inflammatory Drugs: Its In-Vitro Application," American Journal of Analytical Chemistry, Vol. 3 No. 4, 2012, pp. 328-337. doi: 10.4236/ajac.2012.34045.

[1]   J. M. Nelson, T. M. Chiller, J. H. Powers and F. J. Angulo, “Fluoroquinolone-Resistant Campylobacter Species and the Withdrawal of Fluoroquinolones from Use in Poultry: A Public Health Success Story,” Clinical Infectious Diseases, Vol. 44, No. 7, 2007, pp. 977-980. doi:10.1086/512369

[2]   D. V. Ivanov and S. V. Budanov, “Ciprofloxacin and Antibacterial Therapy of Respiratory Tract Infections,” Antibiotiki i Khimioterapiia, Vol. 51, No. 5, 2006, pp. 29-37.

[3]   A. Sivalakshmidevi, K. Vyas and G. Om Reddy, “Spar- floxacin, an Antibacterial Drug,” Acta Crystallographica, Vol. 56, No. 3, 2000, pp. 115-116.

[4]   O. G. Francis, G. F. Roger and G. W. David, “Antibiotic and Chemotherapy,” 7th Edition, Churchill Livingstone, Philadelphia, 1997.

[5]   Medical Economics Staff, “Physician Desk Reference,” 52nd Edition, Churchill Livingstone, New York, 1998.

[6]   M. I. Andersson and A. P. MacGowan, “Development of the Quinolones,” Journal of Antimicrobial Chemotherapy, Vol. 51, Suppl. 1, 2003, pp. 1-11.

[7]   M. S. Barrett, R. N. Jones, M. E. Erwin, D. M. Johnson and B. M. Briggs, “Antimicrobial Activity Evaluations of Two New Quinolones,” Diagnosis of Microbiology Infectious Diseases, Vol. 14, No. 5, 1991, pp. 389-401. doi:10.1016/0732-8893(91)90066-O

[8]   G. C. Crumplin, “Aspects of Chemistry in the Development of the 4-Quinolone Antibacterial Agents,” Reviews of Infectious Diseases, Vol. 10, Suppl. 1, 1988, pp. 2-9.

[9]   N. Sultana, M. S. Arayne, S. Gul and S. Shahmim, “Spar- floxacin-Metal Complexes as Antifungal Agents—Their Synthesis, Characterization and Antimicrobial Activities,” Journal of Molecular Structure, Vol. 975, No. 1-3, 2010, pp. 285-291. doi:10.1016/j.molstruc.2010.04.038

[10]   P. H. Edelstein, M. A. C. Edelstein, K. H. Lehr and J. J. Ren, “In-Vitro Activity of Levofloxacin against Clinical Isolates of Legionella spp., Its Pharmacokinetics in Gui-nea Pigs, and Use in Experimental Legionella pneumophila Pneumonia,” Journal of Antimicrobial Chemotherapy, Vol. 37, No. 1, 1996, pp. 117-126. doi:10.1093/jac/37.1.117

[11]   J. A. O. Gonzalez, M. C. Mochon and F. J. B. De La Rosa, “Simultaneous Determination of Cefepime and the Qui-nolones Garenoxacin, Moxifloxacin and Levofloxacin in Human Urine by HPLC-UV,” Mikrochimica Acta, Vol. 151, No. 1-2, 2005, pp. 39-45. doi:10.1007/s00604-005-0391-y

[12]   H. A. Nguyen, J. Grellet, B. B. Ba, C. Quentin and M. C. Saux, “Simultaneous Determination of Levofloxacin, Ga- tifloxacin and Moxifloxacin in Serum by Liquid Chro- matography with Column Switching,” Journal of Chro- matography B. Analytical Technologies in the Biomedical and Life Sciences, Vol. 810, No. 1, 2004, pp. 77-83.

[13]   E. Nemutlu, S. Kir, O. Ozyuncu and M. S. Beksac, “Simultaneous Separation and Determination of Seven Qui- nolones Using HPLC: Analysis of Levofloxacin and Mo-xifloxacin in Plasma and Amniotic Fluid,” Chromatographia, Vol. 66, Suppl. 1, 2007, pp. 15-24. doi:10.1365/s10337-007-0292-9

[14]   F. A. Siddiqui, M. S. Arayne, N. Sultana, A. Z. Mirza, F. Qureshi and H. Zuberi, “Facile and Manifest Spectropho- tometric Methods for the Determination of Six Quinolone Antibiotics in Pharmaceutical Formulations Using Iron Salts,” Medicinal Chemistry Research, Vol. 19, No. 9, 2009, pp. 1259-1272.

[15]   N. Sultana, N. Shafi, A. Naz and H. Shamshad, “RP- HPLC Method for the Simultaneous Determination of Diltiazem and Quinolones in Bulk Formulations and Human Serum,” Journal of Chilian Chemical Society, Vol. 54, No. 4, 2009, pp. 289-293

[16]   N. Sultana, M. S. Arayne and W. Shehzad, “Simultaneous Determination of Ceftriaxone Sodium and Statins Drugs in Pharmaceutical Formulations and Human Serum by RP-HPLC,” Journal of The Chilean Chemical Society, Vol. 55, No. 2, 2010, pp. 193-198

[17]   S. Koichi, W. L. Lee, T. Toyohide, S. Yasuhide, S. Kiyo- hito, T. Yuji and K. Susumu, “Rapid and Simultaneous Determination of Nonsteroidal Anti-Inflammatory Drugs in Human Plasma by LC-MS with Solid-Phase Extraction,” Analytical and Bioanalytical Chemistry, Vol. 384, No. 7-8, 2006, pp. 1501-1505.

[18]   S. Koichi, W. L. Lee, T. Toyohide, S. Yasuhide, S. Kiyohito, T. Yuji and K. Susumu, “On-Line Sample Extraction and Enrichment of Non-Steroidal Anti-Inflammatory Drugs by Pre-Column in Capillary Liquid Chromatography Mass Spectrometry,” Journal of Chromatography B, Vol. 846, No. 1-2, 2007, pp. 176-183. doi:10.1016/j.jchromb.2006.08.041

[19]   K. E. V. Nagoji, S. Vijayasrinivas, M. K. Kumar, N. Mathivanan, M. S. Kumar and M. E. Rao, “Simultaneous Reverse Phase HPLC Estimation Of Nimesulide and Diclofenac Sodium,” Indian Journal of Pharmaceutical Sciences, Vol. 65, No. 4, 2003, pp. 407-409.

[20]   N. Srinivas, L. Narasu, B. P. Shankar and R. Mullangi, “Development and Validation of a HPLC Method for Simultaneous Quantitation of Gatifloxacin, Sparfloxacin and Moxifloxacin Using Levofloxacin as Internal Standard in Human Plasma: Application to a Clinical Phar- macokinetic Study,” Biomedical Chromatography, Vol. 22, No. 11, 2008, pp. 1288-1295. doi:10.1002/bmc.1060

[21]   H. R. N. Marona, J. A. S. Zuanazz and E. E. S. Schapoval “Determination of Sparfloxacin and Its Degradation Products by HPLC,” Journal of Antimicrobial Chemotherapy, Vol. 44, No. 2, 1999, pp. 301-302 doi:10.1093/jac/44.2.301

[22]   A. M. El-Didamony, “Fluorescence Probe Enhanced Spectrofluorimetric Method for the Determination of Spar floxacin in Tablets and Biological Fluids,” Luminescence, Vol. 26, No. 2, 2010, pp. 112-117. doi:10.1002/bio.1192

[23]   A. M. El-Didamony, “Spectrophotometric Determination Method of Sparfloxacin in Pharmaceutical Preparations by Ternary Complex Formation with Pd (II) and Eosin,” Analytical Letters, Vol. 40, No. 14, 2007, pp. 2708-2720. doi:10.1080/00032710701588408

[24]   H.-Y. Cho, S.-A. Park and Y.-B. Lee, “Improvement and Validation of an HPLC Method for Examining the Effects of the MDR1 Gene Polymorphism on Sparfloxacin Phar- macokinetics,” Journal of Chromatography B, Vol. 834, No. 1-2, 2006, pp. 84-92.

[25]   A. P. Argekar and S. J. Shah, “Stability Indicating HPLC Method for the Determination of Sparfloxacin (Spar),” Analytical Letters, Vol. 32, No. 7, 1999, pp. 1363-1370. doi:10.1080/00032719908542903

[26]   H. R. N. Marona and E. E. S. Schapoval, “A High-Performance Liquid Chromatographic Assay for Sparfloxacin,” Journal of Pharmaceutical and Biomedical Analy- sis, Vol. 20, No. 3, 1999, pp. 413-417. doi:10.1016/S0731-7085(98)00102-2

[27]   N. N. Rahman and S. Ahmad, “Development of Quantitative Analysis of Sparfloxacin by High Performance Liq- uid Chromatography,” The Dhaka University Journal of Pharmaceutical Sciences, Vol. 6, No. 1, 2007.

[28]   A. Srikar, K. P. Channabasavaraj, G. Dharmamoorty, N. Valmiki, C. Chinnappa and T .V. Babu, “Spectrophotometric Methods for Quantitative Estimation of Sparflox-acin in Bulk and Pharmaceutical Dosage Forms,” Journal of Pharmaceutical Sciences and Research, Vol. 1, No. 2, 2009, pp. 13-15.

[29]   J. R. Brouwers, “Drug Interactions with Quinolone Anti- bacterials,” Drug Safely, Vol. 7, No. 4, 1999, pp. 268-281. doi:10.2165/00002018-199207040-00003

[30]   T. Yoshino, M. Noguchi, H. Okutsu, A. Kimoto, M. Sa- samata and K. Miyata, “Celecoxib Does Not Induce Convulsions nor Does It Affect GABAA Receptor Binding Activity in the Presence of New Quinolones in Mice,” European Journal of Pharmacology, Vol. 501, No. 1-3, 2005, pp. 69-76. doi:10.1016/j.ejphar.2004.11.038

[31]   F. Leite, “Validation in Chemical Analysis Atom,” 4th Edition, átomo, S?o Paulo, 2002, pp. 69-72.

[32]   United States Pharmacopeia, “United States Pharmacopeial Convention,” 21st Edition, Rockville, 2002.

[33]   L. N. Linda and Center for Drug Evaluation and Research (CDER) “Reviewer Guidance: Validation of Chromatographic Methods,” Center for Drug Evaluation and Research, Rockville, 1994.

[34]   M. W. Dong, “Modern HPLC for Practicing Scientists,” John Wiley and Sons, Hoboken, 2006. doi:10.1002/0471973106

[35]   United States Pharmacopeia, 28th Edition, United States Pharmacopeial Convention, Rockville, 2005.

[36]   ICH, “International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use,” Vol. 4, Washington DC, 11-12 September 2002, pp. 69-72.

[37]   Association of Official Analytical Chemists, “Official Methods of Analysis of AOAC International,” 17th Edition, AOAC, Gaithersburg, 2002, p. 20.