RP-HPLC Method Development and Validation of Pazufloxacin in their Bulk and formulation
Keywords:
Pazufloxacin, RP-HPLC, Methanol, Phosphate buffer, Validation, ICH guidelinesAbstract
The present work was the development of a simple, efficient, and reproducible reverse-phase high performance liquid chromatographic (RP-HPLC) method for determination of Pazufloxacin (PFX) in bulk and its injection dosage form. The solvent system and wavelength were optimized in order to maximize the sensitivity of the proposed method and detection wavelength was carried out at 249 nm. The separation was achieved on HPLC binary gradient system equipped with HPLC 3000 series UV detector and Agilent Zorbax column C18 (4.6mm×50mm×5µm). The optimized mobile phase composition was methanol: phosphate buffer pH 4 (50:50%v/v). The separation of PFX was carried out on Kromasil C-18 (250 × 4.6 mm×5 ????m) column using phosphate buffer pH 4 and methanol by linear gradient program. Flow rate was 1.0 ml/min with a column temperature of 30?C. The method was validated in terms of accuracy, precision, linearity, LOD & LOQ of sample solution as per ICH guidelines. Linearity was observed in the concentration range of 5-25 ?g/ml & gave mean correlation coefficient 0.998. The developed RP-HPLC method was found to be accurate, precise and was successful applied to a Pazufloxacin bulk powder and its marketed formulation for qualitative estimation of Pazufloxacin.
Downloads
References
Maryadele, J. O., Patricia, E. H., Cherie, B. K., Kristin, J. R., Catherine, M. K., Maryann, R. D., 2006. The Merck index. 14th edition. United States Pharmaceutical Company Merck & Co., 1217.
Zhanel, G. G., Ennis, K., Vercagnel, L., Walkty, A., Gin, A. S., Embil, J., Smith, H., Hoban, D. J., 2002. A critical review of the fluroquinolones: Focus on Respiratory infection. Drugs, 62(1): 13-59.
Zhanel, G. G., Fontaine, S., Adam, H., Schurek, K., Mayer, M., Nareddin, A. M., Gin, A. S., Rubinstein, E., Hoban, D. J., 2006. A review of New Fluroquinolones: Focus on their use in respiratory tract infection. Trea.Resp.Medi. 5: 437-465.
Hawkey, P. M., 2003. Mechanism of Quinolones Action and microbial Response. J.Anti.Chem.. Suppl: 1, 29-35.
Nomura, N., Mitsuyama, J., Furata, Y., Yamada, H., Nakata, M., Fukuda, T., Takhata, M., Minami, S., 2002. In Vitro and In vivo antibacterial activity of Pazufloxacin Mesilate, A new Injectable Quinolones. Jap. J. Antibi., 55(4): 412-439.
Mitsuyama, J., Takhata, M., Yamashiro, Y., 1999. Antibacterial activity of new Injectable quinolones: Pazufloxacin Mesylate. Jap. J.Chemother. 47: 37-64.
Muratani T, Inoue M, Mitsuhashi S., 1992. In-vitro activity of T-3761, a new fluoroquinolone. Antimicrob Agents. Chemother. 36: 2293-2303.
Fukuoka Y, Ikeda Y, Yamashiro Y, Takahata M, Todo Y, et al. (1993) In vitro and in vivo antibacterial activities of T-3761, a new quinolone derivative. Antimicrob Agents. Chemother. 37: 384-392.
Higa, F., Akamine, M., Haranaga, S., Tohyama, M., 2005. In-vitro activity of pazufloxacin, Tosufloxacin and other quinolones against Legionella species. J. Antimicrob. Chemother. 56: 1053-1057.
Rewatkar, N.S., Dinesh, R., Mahavir, C., Ghante, H., Umarkar, A.R., 2011. Development of UV spectrophotometric methods for estimation of Pazufloxacin in infusion form using absorbance ratio method Research. J.Pharm.Biol.Chem.Sci. 2: 456-463.
Rewatkar, N.S., Umarkar, A.R., Chaple, D., Ghante, H.2011.Validated spectrophotometric determination of pazufloxacin in formulation. J. Pharm. Res. 4: 1394-1395.
Wang, X., Chen, S., Zhao, H., Jin, L. 2005. Europium sensitized chemiluminescence determination of pazufloxacin mesylate in urine and serum. Anal. Lett. 38: 971-979.
Yang, C., Zhang, Z., Chen, S., Yang, F. 2007. Molecularly imprinted on-line solidphase extraction combined with chemiluminescence for the determination of pazufloxacin mesylate Mikrochim. Acta. 159: 299-304.
Jin, J., Zhang, X. 2008. Spectrophotometric studies on the interaction between pazufloxacin mesilate and human serum albumin or lysozyme. J. Lumin. 128:81-86.
Chen, S., Ma, H., Zhao, H., Feng, R., Jin, L.2004.Terbium-sensitized fluorescence method for the determination of pazufloxacin mesilate and its application. Anal. Sci. 20: 1075-1078.
Lu, Z., Rong, YG, Ruo Y, Yain C, SuMing C. (2007) A capacitive sensor based on molecularly imprinted polymers and poly(p-aminobenzene sulfonic acid) film for detection of pazufloxacin mesylate Sci China Ser B-Chem. 50: 547-553.
Zu, L.Z., Jian, J.L., Ling, B.Q., Ran, Y., 2008. Determination of Pazufloxacin Mesylas by Capillary Electrophoresis with Electrochemiluminescence Detection. Chinese. J. Anal. Chem. 36: 941-946.
Zhou, S,, Ouyang, J,, Baeyens, W.R., Zhao, H., Yang, Y., 2006. Chiral separation of four fluoroquinolone compounds using capillary electrophoresis with hydroxypropyl-beta-cyclodextrin as chiral selector. J. Chromatogr. A. 1130: 296-301.
Wang, Y., Baeyens, W.R., Huang, C., Fei, G., He, L., 2009. Enhanced separation of seven quinolones by capillary electrophoresis with silica nanoparticles as additive. Talanta. 77: 1667-1674.
Li, Q., Wang, R., Pei, F., 2004. Determination of pazufloxacin mesylate in human plasma and urine by high performance liquid chromatography. Asian Journal of Drug Metabolism and Pharmacokinetics Asian J. Dug. Meta.Pharmaco. 4: 289-294.
Zhang, Z., Yang, G., Wang, D., Liang, G., Chen, Y., 2004. Chiral Separation and Enantiomeric Purity Determination of Pazufloxacin Mesilate by HPLC Using Chiral Mobile Phase Additives. J. Liq. Chromatogra. Relat. Technol. 27: 813-827.
Zhang, H., Ren, Y., Bao, X., 2009. Simultaneous determination of (fluoro) quinolones antibacterials residues in bovine milk using ultra performance liquid chromatography-tandem mass spectrometry. J. Pharm. Biomed. Anal. 49: 367-374.
Watabe, S., Yokoyama, Y., Nakazawa, K., Shinozaki, K., Hiraoka, R., 2010. Simultaneous measurement of pazufloxacin, ciprofloxacin, and levofloxacin in human serum by high-performance liquid chromatography with fluorescence detection. J. Chromatogr. B. Analyt. Technol. Biomed. Life Sci. 878: 1555-1561.
Phapale, P.B., Lee, H.W., Kim, S.D., Lim, M.S., Kale, D.D., 2010. Analysis of Pazufloxacin Mesilate in Human Plasma and Urine by LC with Fluorescence and UV Detection, and Its Application to Pharmacokinetic Study. Chromatographia. 71: 101-106.
Rewatkar, N.S., Umarkar, A.R., Chaple, D., Ghante, H., 2011. A validated stability indicating RP-HPLC method for the estimation of pazufloxacin in presence of its degradation products. J. Pharm. Res. 4: 3060-3062.
Published
How to Cite
Issue
Section
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Copyright © Author(s) retain the copyright of this article.
