RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF GATIFLOXACIN AND FLURBIPROFEN IN PHARMACEUTICAL DOSAGE FORM

  • Kavitha Rayala Department of pharmaceutical analysis&quality assurance Malla reddy college of pharmacy Osmania university
  • Sridhar Siddiraju
  • Muvvala Sudhakar

Abstract

 

Objective: The aim of this work was focused on to develop and validate an accurate, simple reverse phase high-performance liquid chromatography
(HPLC) method for simultaneous estimation of gatifloxacin and flurbiprofen in pharmaceutical dosage form.
Methods: The chromatographic separation was performed on a kromosil C18 column (150 mm × 4.6 mm × 5 μ), with a mobile phase comprising of
a mixture of potassium dihydrogen orthophosphate and acetonitrile (48:52) and pH is adjusted to 7.5 by adding 1 ml triethylamine, at a flow rate of
0.8 ml/minutes, with detection at 245 nm.
Results: Retention times of gatifloxacin and flurbiprofen were found to be 2.3 minutes and 5.6 minutes respectively. The developed method was
validated according to ICH guidelines. Linearity of gatifloxacin was found to be in the range of 75-450 μg/ml and that for flurbiprofen was found
to be in the range of 7.5-45 μg/ml. The percentage recoveries for both drugs were found in the range of 99-101%. The limit of detection and limit
of quantification values for gatifloxacin were found to be 0.38 and 1.16 μg/ml and that for flurbiprofen were found to be 0.05 and 0.14 μg/ml,
respectively.
Conclusion: The proposed HPLC method is simple, rapid, isocratic, specific, accurate and precise. Hence, this method can be recommended for the
estimation of gatifloxacin and flurbiprofen in pharmaceutical dosage form.
Keywords: Gatifloxacin, Flurbiprofen, Reverse phase high performance liquid chromatography method, Validation.

 

References

1. Prathap B, Rajendran SS, Dinakar A, Srinivasa G, Ashok Kumar J, Roosewelt C. Simultaneous determination of gatifloxacin and ambroxol hydrochloride from tablet dosage form using RP-HPLC. Int J Res Pharm Sci 2010;1(3):325-7.
2. Najma S, Saeed Arayne M, Rubina S, Safila N. RP-HPLC Method for the simultaneous determination of lisinopril and NSAIDS in API, pharmaceutical formulations and human serum. Am J Anal Chem 2012;3:147-52.
3. Khan IU, Naeem SR, Irfana M, Muhammad A, Syed SR. Stability-indicating RP-HPLC method for simultaneous determination of gatifloxacin and flurbiprofen in binary combination. Quim Nova 2013;37:1-6.
4. Razzaq SN, Mariam I, Khan IU, Ashfaq M. Development and validation of liquid chromatographic method for gatifloxacin and ketorolac tromethamine in combined dosage form. J Liq Chromatogr 2012;35(4):651-61.
5. Prathap B, Nagarajan G, Dinakar A, Srinivasa G, Ranjit Singh BR, Shahul H. Spectrophotometric method for simultaneous estimation of gatifloxacin and ambroxol hydrochloride in tablet dosage form. Der Pharm Lett 2011;3(3):62-8.
6. Srinivas N, Narasu L, Shankar BP, Mullangi R. 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 pharmacokinetic study. Biomed Chromatogr 2008;22(11):1288-95.
7. Mahmoud MS, El-Shanawany AA, El-Adl SM, Abdel-Aziz LM, Hisham AH. Rapid RP-HPLC method for simultaneous estimation of sparfloxacin, gatifloxacin, metronidazole and tinidazole. Asian J Pharm Res 2011;1(4):119-25.
8. Guo C, Dong P, Chu Z, Wang L, Jiang W. Rapid determination of gatifloxacin in biological samples and pharmaceutical products using europium-sensitized fluorescence spectrophotometry. Luminescence 2008;23(1):7-13.
9. Jinal MD, Vishnu MP, Rajesh P, Dushyant S. Development and validation of spectrofluorometric method for analysis of gatifloxacin and flurbiprofen sodium in ophthalmic dosage form. Inventi Rapid Pharm Anal Qual Assur 2014;ppaqa/1421/14.
10. Hasna M, Amir AS, Bassam N. Potentiometric determination of gatifloxacin, ciprofloxacin in pharmaceutical formulations. Int J Pharm Pharm Sci 2012;4(4):537-42.
11. Suhagia BN, Shah SA, Rathod IS, Patel HM, Shah DR, Marolia BP, et al. Determination of gatifloxacin and ornidazole in tablet dosage forms by high-performance thin-layer chromatography. Anal Sci 2006;22(5):743-5.
12. Faria AF, de Souza MV, de Oliveira MA. Validation of a capillary zone electrophoresis method for the determination of ciprofloxacin, gatifloxacin, moxifloxacin and ofloxacin in pharmaceutical formulations. J Braz Chem Soc 2008;19(3):389-96.
13. Sun H, Wei L, Zuo Y, Wu Y. Effective separation and simultaneous detection of gatifloxacin, amino methyl benzoic acid, cefazolin and cefminox in human urine by capillary zone electrophoresis. J Iran Chem Soc 2011;8(4):1043-51.
14. Sajeev C, Pravin RJ, Ravi Shankar D, Saha RN. Determination of flurbiprofen in pharmaceutical formulations by UV spectrophotometry and liquid chromatography. Anal Chim Acta 2002;463:207-17.
15. Emrah A, Bilal Y. Determination of flurbirofen in pharmaceutical preparations by first-order derivative spectrophotometry method. Indian J Pharmacol 2014;1(2):130-7.
16. Hirai T, Matsumoto S, Kishi I. Simultaneous analysis of several non-steroidal anti-inflammatory drugs in human urine by high-performance liquid chromatography with normal solid-phase extraction. J Chromatogr B Biomed Sci Appl 1997;692(2):375-88.
17. Park KM, Gao ZG, Kim CK. Assay of flurbiprofen in rat plasma using HPLC with fluorescence detection. J Liq Chromatogr 1997;20(12):1849-55.
18. Dhavse VV, Parmar DV, Devarajan PV. High-performance thin-layer chromatographic determination of flurbiprofen in plasma. J Chromatogr B Biomed Sci Appl 1997;694(2):449-53.
19. Vinci F, Fabbrocino S, Fiori M, Serpe L, Gallo P. Determination of fourteen non-steroidal anti-inflammatory drugs in animal serum and plasma by liquid chromatography/mass spectrometry. Rapid Commun Mass Spectrom 2006;20(22):3412-20.
20. Giancarlo A, Marina C, Marica O, Roberto MF, Gary LW. Metabolic profile of NO-flurbiprofen in rat brain and plasma: A LC-MS study. Life Sci 2002;71(13):1487-500.
21. Déglon J, Thomas A, Daali Y, Lauer E, Samer C, Desmeules J, et al. Automated system for on-line desorption of dried blood spots applied to LC/MS/MS pharmacokinetic study of flurbiprofen and its metabolite. J Pharm Biomed Anal 2011;54:359-67.
22. Hamoudová R, Pospísilová M. Determination of ibuprofen and flurbiprofen in pharmaceuticals by capillary zone electrophoresis. J Pharm Biomed Anal 2006;41:1463-7.
23. Chao SH, Ho HT, Chen FA, Lin PY, Yu YC, Wu AB, et al. Identification of flurbiprofen and its photoproducts in methanol by gas chromatography-mass spectrometry. Biomed Chromatogr 2007;21(5):527-33.
24. Patel BK, Valentova J, Hutt AJ. Stereospecific analysis of flurbiprofen and its major metabolites in plasma and urine by chiral-phase liquid chromatography. Chromatographia 2003;57(1):7-18.
Statistics
998 Views | 637 Downloads
How to Cite
Rayala, K., S. Siddiraju, and M. Sudhakar. “RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF GATIFLOXACIN AND FLURBIPROFEN IN PHARMACEUTICAL DOSAGE FORM”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 8, no. 1, Jan. 2015, pp. 242-6, https://innovareacademics.in/journals/index.php/ajpcr/article/view/3613.
Section
Original Article(s)