Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC
A simple, precise and accurate RP-HPLC method was developed and validated for the estimation of gemifloxacin in the tablet dosage form. The separation was achieved on a reversed-phase C-18 column (250 x 4.6 mm i.d., 5 µm) using a mobile phase consisting of acetonitrile/acetate buffer of pH 4.5 (70:30 v/v) at a flow rate of 1.0 ml/min and a detection wavelength of 244 nm. The separation was carried out on an isocratic mode at room temperature. The method was validated as per ICH guidelines for linearity, accuracy, precision, robustness, LOD, LOQ and specificity. The developed method showed good linearity over the concentration range of 50-150 µg/ml (r2=0.995). The average percentage recovery was 99.77%. The LOD and LOQ were 12.678 µg/ml and 14.261 µg/ml, respectively. Based upon validation studies, the developed method can be successfully applied for the routine analysis of gemifloxacin in bulk drugs as well as pharmaceutical dosage forms.
Keywords: Gemifloxacin, Tablet dosage form, RP-HPLC, Validation, ICH guidelines
2. Panda SS, Ravi Kumar BVV, Mohanta G, Patel PK. Reverse Phase Ultra-Fast Liquid Chromatographic Method for Determination of Gemifloxacin Mesylate in Tablet Dosage Form. J PharmaSciTech 2012; 2(1):20-25
3. Sagar BW, Anand MM, Sohan SC. Simultaneous spectrophotometric estimation of Gemifloxacin mesylate and Ambroxol hydrochloride in tablets. Anal Chem 2012; 11(5):188-194
4. Madhuri D, Chandrasekhar KB, Devanna N, Somasekhar G. Direct And Derivative Spectrophotometric Estimation Of Gemifloxacin By Chelation With Palladium(II) Ion. Rasayan J Chem 2010; 3(1):159-165.
5. Jyothirmayee D, Sai Babu GS, Devala Rao G. Spectrophotometric Determination of Gemifloxacin in Pharmaceutical Formulations. Asian J Chem 2010; 22(2):1634-1636.
6. Nagavalli D, Abirami G, Kumar SK Validated HPLC method for the simultaneous estimation of gemifloxacinmesylate and ambroxol hydrochloride in bulk and tablet dosage form. J Pharm Res 2011; 4(6):1701-1703.
7. Panchumarthy R, Garikapati D, Chapala D, et al. A validated RP-HPLC method for the determination of gemifloxacin in bulk and pharmaceutical dosage forms. J Chem Pharm Sci 2013; 6(1):46-54.
8. Naaz H, Srikanth P, Rudrapal M, Sarwa KK. Development and validation of analytical methods for the estimation of gallic acid in the herbal formulation of Amalaki by UV spectrophotometry and RP-HPLC. Asian J Chem 2020; in press.
9. Rudrapal M, Oduri MU, Samidala NR, Surya Kiran BVVS, Junejo JA, Singh KD, Chakraborty T, Debnath M. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Olmesartan and Hydrochlorothiazide in Tablet Dosage Form. Oriental J Chem 2015; 31(2):921-926.
10. Surya Kiran BVVS, Sridhar N, Raghavendra M, Rudrapal M. Development and validation of a RP-HPLC method for simultaneous estimation of minoxidil and aminexil in topical formulation. Asian J Chem 2016; 28(1):157-160.
11. Green JM, A Practical Guide to Analytical Method Validation. Anal Chem 1996; 689:305A-309A.
12. International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Validation of analytical procedures: Methodology, ICH-Q2B, Geneva, 1996.
13. Wegscheider W. Validation of analytical methods. In: Guenzler H, editor. Accreditation and Quality Assurance in Analytical Chemistry. Berlin: Springer Verlag; 1996.
14. Michael E. Analytical Method Development. In: Swartz, Ira SK, editors. Analytical Method Development and Validation. 1st ed. New York: Marcel Dekker Inc; 2009.
15. Parida RK. Overview of Pharmaceutical Validation and Process Controls in Drug Development. Der Pharmacia Sinica 2010; 1(1):11-19.
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