UV-HPLC METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF BESIFLOXACIN HYDROCHLORIDE
Objectives: The objective of the present investigation was to develope and validates a new, rapid, accurate high performance liquid chromatographic (HPLC) method for the quantification of Besifloxacin Hydrochloride.
Methods: Isocratic UV-HPLC separation was performed using a Zodiac C18 (150 X 4.6 mm) column, with 150 volume of Acetonitrile and 350 mL of Methanol in 500 mL buffer as mobile phase at a flow rate of 2 mL/min and UV detection at 295nm..
Results: The sample found stable for 24 hours in analyte solution and compatible with nylon filter. The Beerâ€™s law plots were found to be linear over the concentration range 70% to 130% with a correlation coefficient (r2) 0.9999 in diluent, phosphate buffer and simulated tear media. The %RSD was found less than 2% shows good precision, acceptable accuracy and reproducibility of the new method for the determination of Besifloxacin Hydrochloride.
Conclusion: The method was validated as per the ICH guidelines. The method is accurate and can be applied for qualitative analysis of Besifloxacin Hydrochloride in bulk drug and in formulation.
2.Besifloxacin Hydrochloride. DrugBank. Available at:
3.Arnold DR, Granvil CP, Ward KW, Proksch JW. Quantitative determination of Besifloxacin Hydrochloride, a novel fluoroquinolone antimicrobial agent, in human tears by liquid chromatography-tandem mass spectrometry. J Chromatog B 2008;867:105-110.
4.Balzli CL, Caballero AR, Tang A, Weeks AC, OÂ´Callaghan RJ. Penetration and effectiveness of prophylactic fluoroquinolones in experimental methicillin-sensitive or methicillin-resistant Staphylococcus aureus anterior chamber infections. J Cataract Refract Surg 2010;36:2160â€“7.
5.Donnenfeld ED, Comstock TL, Proksch JW. Human aqueous humor concentrations of Besifloxacin Hydrochloride, moxifloxacin, and gatifloxacin after topical ocular application. J Cataract Refract Surg 2011;37:1082â€“9.
6.Kumar S, Kumar M, Majumdar DK, Sharma PK, Singh CL, Singh A. Development and Validation of Different Ultraviolet-Spectrophotometric Methods for the Estimation of Besifloxacin Hydrochloride in Different Simulated Body Fluids. Indian Journal of Pharmaceutical Sciences 2015;77(4):399-404.
7.MÃ¡rcia CN Costa, Amanda T Barden, Juliana MM Andrade, TÃ©rcio P Oppe, Elfrides ES Schapoval. Quantitative evaluation of Besifloxacin Hydrochloride ophthalmic suspension by HPLC, application to bioassay method and cytotoxicity studies. Talanta 2014;119:367â€“374.
8.Torkildsen G, Proksch JW, Shapiro A, Lynch SK, Comstock TL. Concentrations of Besifloxacin Hydrochloride, gatifloxacin, and moxifloxacin in human conjunctiva after topical ocular administration. Clin. Ophthalmol 2010;4:331â€“341.
9.Wang Z, Wang S, Zhu F, Chen Z, Lyu Zeng S. Determination of enantiomeric impurity in Besifloxacin Hydrochloride hydrochloride by chiral high-performance liquid chromatography with precolumn derivatization. Chirality 2012;24:526â€“531.
10.ICH Harmonised Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology Q2(R1). Available at: < http://www.ich.org/home.html >. Accessed on: 11 Nov 2016.
11.Thompson M, Ellison SLR, Wood R. Harmonised guidelines for single-laboratory validation of methods of analysis (IUPAC Technical report). Pure Appl. Chem 2002;74(5):835-855.
12.Paulsson M, HÃ¤gerstrÃ¶m H, Edsman K. Rheological studies of the gelation of deacetylated gellan gum (Gelrite) in physiological conditions. Eur J Pharm Sci 1999;9:99â€“105.
The publication is licensed under CC By and is open access. Copyright is with author and allowed to retain publishing rights without restrictions.