Method Development and Validation of Gemifloxacin in Tablet Dosage Form by RP-HPLC
Abstract
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
Keywords:
Gemifloxacin, Tablet dosage form, RP-HPLC, Validation, ICH guidelinesDOI
https://doi.org/10.22270/jddt.v10i4.4217References
Danta CC, Sahu S. Simple and Rapid Spectrophotometric Estimation of Gemifloxacin Mesylate in Bulk and Tablet Formulations. Int J Phar Tech Res 2011; 3(1):133-135.
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
Sagar BW, Anand MM, Sohan SC. Simultaneous spectrophotometric estimation of Gemifloxacin mesylate and Ambroxol hydrochloride in tablets. Anal Chem 2012; 11(5):188-194
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.
Jyothirmayee D, Sai Babu GS, Devala Rao G. Spectrophotometric Determination of Gemifloxacin in Pharmaceutical Formulations. Asian J Chem 2010; 22(2):1634-1636.
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.
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.
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.
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.
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.
Green JM, A Practical Guide to Analytical Method Validation. Anal Chem 1996; 689:305A-309A.
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.
Wegscheider W. Validation of analytical methods. In: Guenzler H, editor. Accreditation and Quality Assurance in Analytical Chemistry. Berlin: Springer Verlag; 1996.
Michael E. Analytical Method Development. In: Swartz, Ira SK, editors. Analytical Method Development and Validation. 1st ed. New York: Marcel Dekker Inc; 2009.
Parida RK. Overview of Pharmaceutical Validation and Process Controls in Drug Development. Der Pharmacia Sinica 2010; 1(1):11-19.
Published
Abstract Display: 572 
PDF Downloads: 693 How to Cite
Issue
Section
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
How to Cite
.