RP-UFLC Method Development and Validation for Simultaneous Estimation of Levofloxacin in Bulk and Tablet

International Journal of Pharmacy and Biomedical Engineering

© 2019 by SSRG - IJPBE Journal

Volume 6 Issue 1

Year of Publication : 2019

Authors : Pooja M, Sowmya H.G, Jose Gnana Babu C

10.14445/23942576/IJPBE-V6I1P107

How to Cite?

Pooja M, Sowmya H.G, Jose Gnana Babu C, "RP-UFLC Method Development and Validation for Simultaneous Estimation of Levofloxacin in Bulk and Tablet," SSRG International Journal of Pharmacy and Biomedical Engineering, vol. 6,  no. 1, pp. 46-53, 2019. Crossref, https://doi.org/10.14445/23942576/IJPBE-V6I1P107

Abstract:

A simple, novel, accurate, precise, linear, rapid, and economical UFLC method was developed to estimate Levofloxacin. The chromatographic separation was achieved using a Phenomenex Luna 5µ C18 (2) 100A (250 x 4.60mm 5 µ) column and binary gradient elution, a mobile phase comprising of Methanol: 0.3% Orthophosphoric acid (70: 30) at PH 1.66 was adjusted with water. The flow rate was 1.0 ml/min with detection at 294 nm using a UV detector and drug eluted with a retention time of 2.29 min. The calibration curves were linear (r²=0.999) in the concentration range of 0.2-1.0 μg/ml. The limit of detection and limit of quantitation was0.5931 and 1.7974μg/ml,respectively. Thus the simple, novel, economical, accurate, precise, and rapid UFLC method was developed to estimateLevofloxacin and validated as per ICH guidelines. Hence the method holds good for routine analysis of Levofloxacin in the pure and pharmaceutical dosage form.

Keywords:

- Levofloxacin, ICH guidelines, UFLC, Validation.

References:

[1] https://en.wikipedia.org/wiki/Levofloxacin.
[2] https://www.drugbank.ca>drugs.
[3] Pradeep Singh, Vikash Kumar Chaudhari, Praveen Kumar Verma, Amit Kumar Singh, Vijay Kumar Yadav. “Development and Validation of UV-visible Spectrophotometric Method for the Determination of Levofloxacin in bulk and tablet formulation”. International Journal of Research and Development in Pharmacy and Life Sciences. 2015; 4(1):1375-78.
[4] Swapna G, Deepika G. “Development and Validation New analytical methods of Levofloxacin in IV Infusions by UVVisible spectrophotometric methods and Determine Assay, % Purity and Stability in Three Marketed Brands”. International Journal of Science and Research. 2014; 3(6):960-63.
[5] Neetu Sachan, Phool Chandra, MayankYadav. “Simple and validated UV-Spectrophotometric Method for the Estimation of Levofloxacin in bulk and pharmaceutical dosage forms”. International Journal of Pharmacy and Pharmaceutical Sciences. 2012;4(5):383-85.
[6] Lonikar NB, Baby Sudha Lakshmi P, Mallikarjuna Gouda M. “A Selective UV Spectrophotometric analytical method to quantify the Levofloxacin in the bulk sample”. European Journal of Pharmaceutical And Medical Research. 2016; 3(9):351-53.
[7] Lakshmi Sivasubramanian, D. Balanagamani, R. Mamatha. “Simultaneous Spectrophotometric Determination of Azithromycin and Levofloxacin from the solid dosage form”. Journal of Pharmacy Research. 2018; 12(5):679-83.
[8] Mahfuza Maleque, Md. RaquibulHasan, FarhadHossen, Sanjana Safi. “Development and Validation of a simple UV Spectrophotometric Method for the Determination of Levofloxacin in bulk and Marketed dosage formulations”. Journal of Pharmaceutical Analysis. 2012; 2(6):454–57.
[9] Most. Umme Bushra, Md. Saddam Hossain, Kh. Tanvir Ahmed, Jeb-Un Nesa, Md. Firoz Mahmud. “Development and Validation of a simple UV Spectrophotometric Method for the Determination of Levofloxacin both In bulk and pharmaceutical formulation”. International Journal of Pharmaceutical Science and Research. 2014; 5(6): 2369-73.
[10] Nájla Mohamad Kassab. “Development and Validation of UV Spectrophotometric Method for Determination of Levofloxacin in pharmaceutical dosage forms”. Quim. Nova. 2010; 33(4): 968-71.
[11] Tamilarasi. G, Dr.Vetrichelvan T, Dr.Vekappayya D, Tharabai R, Yuvarajan K. “Spectrophotometric Estimation of Levofloxacin hemihydrate and Cefpodoximeproxetil in the tablet”. International Journal of Pharmacy and Pharmaceutical Sciences. 2014; 6(4):646-48.
[12] Sandeep Rahar, Sunny Dogra, Deepak Panchru, PrabhSimran Singh, Gagan Shah. “Development and Validation of UVvisible spectroscopic method for the Estimation of Levofloxacin hemihydrate in Bulk and Marketed formulation”. International Journal of Institutional Pharmacy and Life Sciences. 2011; 1(2):57-69.
[13] VN Desai, Ozadheoghene E Afieroho, BO Dagunduro, TJ Okonkwo, CC Ndu. “A Simple UV Spectrophotometric Method for the Determination of Levofloxacin in Dosage Formulations”. Tropical Journal of Pharmaceutical Research. 2011; 10(1):75-79.
[14] K. E. Pravallika, M. Bhavya, P. Ravi, K. Hemavathi, D. LalithaKumari. “Quantitative Determination of Levofloxacin hemihydrate in bulk and tablets by UV spectrophotometry, zero, and first-order derivative methods”. Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 2014; 2(3):176 – 82.
[15] Karajgi Santosh Raveendra, Wadekar Ashwini Rajendra, Kotnal Ramaling Bhagawantrao, Kalyane Navanath Vishwanathappa. “AUC UV Spectrophotometric method for the determination of Cefpodoximeproxetil and Levofloxacin hemihydrate in multi-component pharmaceuticals”. World Journal of Pharmacy and Pharmaceutical Science. 2016; 5(6):1848-59.
[16] Supriya Ulhas Kubal, Sachi S. Kudchadkar. “Development and Validation of UV Spectrophotometric Method for the Simultaneous Estimation of Cefpodoxime proxetil and Levofloxacin hemihydrate in the combined dosage form”. World Journal of Pharmaceutical Research. 2016; 5(5):1554- 64.
[17] Rekha Rajeevkumar, D. Nagavalli, P. Rajeev Kumar, T. Devi. “Derivative Spectrophotometric Estimation of Levofloxacin hemihydrate and Ornidazole”. International Journal of ChemTech Research. 2010; 2(4):2145-49.
[18] Manimala M, Ravindra Reddy K. Hepcykala Rani D. “Development and Validation of novel UV spectrophotometric Determination of Levofloxacin hemihydrate in bulk and pharmaceutical dosage forms”. Der PharmaChemica. 2013; 5(1):47-50.
[19] Makarand Avhad, Dr. CG. Bonde. “Development and Validation of Simultaneous UV Spectrophotometric Method for the Determination of Levofloxacin and Ambroxol in tablets”. International Journal of ChemTech Research. 2009; 1(4):873-88.
[20] Shirkhedkar AA, Surana SJ, “Quantitative determination of Levofloxacin hemihydrate in bulk and tablets by UVspectrophotometry and first-order derivative methods”. Pak. J. Pharm. Sci. 2009; 22(3):301-02.
[21] Abhimanyu Thakur, Rakesh Kumar. “Development and Validation of UV spectrophotometric Method for Determination of Levofloxacin hemihydrate in marketed tablet dosage formulations”. International Journal of Pharmacy and Engineering. 2014; 2(4):479-86.
[22] Mirza Shahed Baig, Mohammed Imran Anees, Mohammed ShakirGhouse, ShaikhNaeem Sadat, Khateeb Muntasiruddin. “Simultaneous Estimation of Levofloxacin and Cefpodoxime proxetil from its tablet dosage form by UV visible spectroscopic methods.” World Journal of Pharmacy and Pharmaceutical Sciences. 2015; 4(10):1562-72.
[23] Patel Dhara, MeshramDhananjay, ParmarVandana, PathakDevanshi, Patel Hiral. “Validated stability-indicating RP-HPLC Method Development and Validation for Simultaneous Estimation of Cefixime trihydrate and Levofloxacin hemihydrate in Pharmaceutical dosage form”. International Journal of Analytical Techniques. 2017; 3(1):1- 12.
[24] Xingjie Guo, XinxingGao, Guocan Yao, Na Guo, Fang An. “A Simple and Rapid High-Performance Liquid Chromatography method to Determine Levofloxacin in human plasma and its use in a bioequivalence study”. Drug DiscovTher. 2007; 1(2):136-40.
[25] Nuthalapati mamatha, B. Thangabalan, S. Manoher Babu. “Development and Validation of RP-HPLC method for Azithromycin and Levofloxacin combined tablet dosage form”. International Journal of Research in Pharmaceutical and Nano Sciences. 2014; 3(3):200-14.
[26] Mohammad A Rashid, FarjahanNur, AsmaRahman, Md. Zakir Sultan, Md. GiasUddin, Amir Hassan, Mansoor Ahmed. “Development and Validation of an RP-HPLC Method for Simultaneous Determination of Levofloxacin and Moxifloxacin in Pharmaceutical Dosage Forms”. Journal of Basis and Applied Sciences. 2013; 9:633-38.
[27] Krupa M. Kothekar, BalasundaramJayakar, Amit P. Khandhar, Rajnish K. Mishra. “Quantitative determination of Levofloxacin and Ambroxol hydrochloride in Pharmaceutical dosage form by Reversed-Phase High-Performance Liquid Chromatography”. European Journal of Analytical Chemistry. 2007; 2(1):21-31.
[28] CH Narasimha Raju BH, KV. Ramana, G. DevalaRao, Parthasarathi Ramamoorthy Thoddi. “Simultaneous RPHPLC Method Development And Validation of Levofloxacin and Ornidazole in combined pharmaceutical dosage forms”. Int. J. Chem. Sci. 2010; 8(4): 2145-52.
[29] Safila Naveed, Najma Sultana, M. SaeedArayne, Huma Dilshad. “A new HPLC method for the assay of Levofloxacin and its application in drug-metal interaction studies”. Journal of Scientific and Innovative Research. 2014; 3(1): 91-96.
[30] Manjula, T, G. Nagasowjanya, A. Ajitha, V. Uma MaheshwaraRao. “Analytical Method Development and Validation for Simultaneous Estimation of Levofloxacin hemihydrate and Ambroxol Hcl in a Combined dosage form by RP-HPLC”. International Journal of Innovative Pharmaceutical Sciences and Research. 2014; 2(9):2179-88.
[31] Dhandhukiya Vipul R, Tiwari Priya S, Godavariya Vijay D. “Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Levofloxacin hemihydrates and Cefixime trihydrate in marketed formulation”. International Research Journal of Pharmacy. 2013; 4(6):81-83.
[32] A. Shravan Kumar, T. Santhosh Kumar, B. Kalyan Kumar, P. VenkateshwarRao, NV. Anil Kumar Ravipati. “Development and Validation of RP-HPLC Method for simultaneous estimation of Levofloxacin and Ornidazole in Pharmaceutical dosage form”. Journal of Pharmacy Research. 2011; 4(11):3864-65.
[33] P. Madhurima, G. Tulja Rani. “Development and Validation of RP-HPLC Method for the Simultaneous Estimation of Azithromycin and Levofloxacin in combined tablet dosage form”. International Journal of Pharmaceutical, Chemical, and Biological Sciences. 2015; 5(1):302-08.
[34] K. Srinivas, Rama Prasad Padhy, Subhash Chandra Dinda. “Novel validated RP-HPLC Method for the Simultaneous Estimation of Levofloxacin and Cefpodoxime Proxetil in Bulk and Tablet dosage form”. International Journal of Advanced in Pharmacy, Biology, and Chemistry. 2014; 3(3):760-65.
[35] AA. Shirkhedkar, SB. Chepurwar, SB. Bari, RA. Fursule, SJ. Surana. “Validated HPTLC Method for Simultaneous Estimation of Levofloxacin hemihydrate and Ornidazole in Pharmaceutical dosage form”. Journal of Chromatographic Science. 2007; 45:531-36.
[36] ICH, Q2A Text on Validation of Analytical Procedures; 1994.
[37] ICH, Q2B Validation of Analytical Methodology; 1996.
[38] ICH, Q2 (R1) Validation of Analytical Procedures: Text and methodology; 2005.
[39] Beckett AH, Stenlake JB. Pharmaceutical Chemistry. 4th ed. Part two. New Delhi: CBS; 1997. 293-99.