RESEARCH PAPER
AQbD Approach- RP-HPLC Method for Optimization, Development and Validation of Garenoxacin Mesylate in Bulk and in Tablets
 
More details
Hide details
1
Z.B. Patil Arts, Science and Commerce College, Deopur, Dhule (MS), INDIA
2
Arts, Commerce and Science College, Bodwad, Dist. Jalgaon (MS), INDIA
Online publish date: 2018-04-15
Publish date: 2018-04-15
 
Eurasian J Anal Chem 2018;13(4):em26
KEYWORDS:
ABSTRACT:
Garenoxacin Mesylate (GRN) is a quinolone antibacterial agent for the management of bacterial illness. The established method illustrates a development of simple, specific and robust method for the analysis of GRN using a reversed phase high-performance liquid-chromatography method on PrincetonSPHERE ULTIMA C18 column (250 mm x 4.6 mm, 5 μm) with PDA detection was carried out at 280 nm. A seven-factor eight-run Taguchi design was applied to factor screening studies and central composite design with α = 1 was utilized to optimization of experimental parameters of RP-HPLC for obtaining anticipated chromatographic resolution. Risk assessment, examine was executed to understand the basic method parameters. From the risk assessment three independent parameters such as percent acetonitrile content, mobile phase pH and flow rate were selected and study the impact of these parameters on the responses. From the design information the optimized chromatographic conditions comprises of acetonitrile: water in the ratio of 60:40 % v/v, pH 3.5 of aqueous phase marked using 0.1 % ortho phosphoric acid, separately. The percent recovery study was executed at three levels, was obeyed in the range of 99 - 101 %. Additional the method was validated as per ICH guidelines.
 
REFERENCES (14):
1. Sweetman S. Martindale: The complete drug reference, 36th Edition, Pharmaceutical press: USA, p. 281. 2009.
2. Liebetrauc A, Rodloff AC, Behra-Miellet J, Dubreuil L. In vitro activities of a new des-fluoro (6) quinolone, garenoxacin, against clinical anaerobic bacteria. Antimicrobial agents and chemotherapy. 2003;47:3667. doi:10.1128/AAC.47.11.3667-3671.2003.
3. Kakde RB, Warthi K, Chilbule RP. Solid Phase Extraction-HPLC Method for Determination and Pharmacokinetic Study of Garenoxacin in Rat Plasma after Oral Administration. International Journal of PharmTech Research. 2017;10:62.
4. Panchal AB, Patel BR, Patel JG, Patel YK, Maurya UJ. Development and validation of stability indicating RP-HPLC method for estimation of Garenoxacin Mesylate in tablet dosage form. International Journal of Pharmacy & Life Sciences. 2017;8.
5. Supriya GN, Kandisa VR, Ravi Kumar BVV. High performance liquid chromatographic method for determination of garenoxacin mesylate in pharmaceutical dosage form. Journal of Biotechnol Biomater. 2012;2:194.
6. González JO, Mochón MC, Rosa de la FB. Simultaneous determination of cefepime and the quinolones garenoxacin, moxifloxacin and levofloxacin in human urine by HPLC-UV. Microchimica Acta. 2005;151:39. doi:10.1007/s00604-005-0391-y.
7. Sakariya SV, Maridia RB, Chauhan SP, Suhagia BN. Development and Validation of Difference Spectrometric Method for the Estimation of Garenoxacin mesylate in Bulk and Pharmaceutical Formulation International Journal of Pharm. Res. Scholars. 2015;4:355.
8. Edlabadkar AP, Rajput AP. Development of Four Simple UV-Spectrophotometry Methods for Estimation of Garenoxacin Mesylate in Bulk Material and in Pharmaceutical Formulation. Der Pharmacia Lettre. 2016;8:213.
9. Dash RN, Mohammed H, Humaira T. An integrated Taguchi and response surface methodological approach for the optimization of an HPLC method to determine glimepiride in a supersaturatable self-nanoemulsifying formulation. Saudi Pharmaceutical Journal. 2016;24:92. doi:10.1016/j.jsps.2015.03.004.
10. Hibbert DB. Experimental design in chromatography: a tutorial review. Journal of chromatography B. 2012;910:2. doi:10.1016/j.jchromb.2012.01.020.
11. Aggarwal A, Singh H, Kumar P, Singh M. Optimizing power consumption for CNC turned parts using response surface methodology and Taguchi’s technique—a comparative analysis. Journal of materials processing technology. 2008;200:373. doi:10.1016/j.jmatprotec.2007.09.041.
12. ICH Harmonized Tripartite Guideline, Q2 (R1): Validation of Analytical Procedures: Text and Methodology, International Conference on Harmonization, Geneva, Switzerland. 2005.
13. Manohar M, Joseph J, Selvaraj T, Sivakumar D. Application of Box Behnken design to optimize the parameters for turning Inconel 718 using coated carbide tools. International Journal of Scientific & Engineering Research. 2013;4:620.
14. Thakur D, Kaur A, Sharma S. Application of QbD based approach in method development of RP-HPLC for simultaneous estimation of antidiabetic drugs in pharmaceutical dosage form. Journal of Pharmaceutical Investigation, 2017;47:229. doi:10.1007/s40005-016-0256-x.
eISSN:1306-3057