Author(s):
Kalyani Farkade, Vikrant Salode, Tejashri Kadu
Email(s):
kalyanifarkade3103@gmail.com
DOI:
10.52711/2231-5675.2023.00045
Address:
Kalyani Farkade1*, Vikrant Salode2, Tejashri Kadu3
1P.R. Pote Patil College of Pharmacy, Amaravati, MS, India.
2P.R. Patil Institute of Pharmacy, Amaravati, MS, India.
3Institute of Pharmacy and Research, Badnera, MS, India.
*Corresponding Author
Published In:
Volume - 13,
Issue - 4,
Year - 2023
ABSTRACT:
A new, simple, rapid, selective, precise and accurate isocratic reverse-phase high-performance liquid Chromatography assay method has been developed to estimate Linezolid in tablet formulations. The separation was achieved using column Inert sustain C18 (250×4.6mm, 5µ) in the mobile phase consisting of methanol: 1% Acetic acid (50:50 v/v). The flow rate was 0.80mL/min-1, and the separated Linezolid was detected using a UV detector at 249nm. Column temperature 45°C and sample temperature ambient and injection volume 20µL. The retention time of Linezolid was noted to be 7.3min. The method was validated as per ICH guidelines. The proposed method was found to be accurate, reproducible, and consistent.
Cite this article:
Kalyani Farkade, Vikrant Salode, Tejashri Kadu. Development and Validation of RP-HPLC Method for the Estimation of Linezolid from Bulk and Formulations. Asian Journal of Pharmaceutical Analysis. 2023; 13(4):273-7. doi: 10.52711/2231-5675.2023.00045
Cite(Electronic):
Kalyani Farkade, Vikrant Salode, Tejashri Kadu. Development and Validation of RP-HPLC Method for the Estimation of Linezolid from Bulk and Formulations. Asian Journal of Pharmaceutical Analysis. 2023; 13(4):273-7. doi: 10.52711/2231-5675.2023.00045 Available on: https://ajpaonline.com/AbstractView.aspx?PID=2023-13-4-9
REFERENCES:
1. Zurenko G. E, Gibson J. K, Shinabarger D. L, Aristoff P. A, Ford C.W, Tarpley W. G, Novel Oxazolidinone–Quinolone Hybrid Antimicrobials. Curr. Opin. C. Pharmacol. 2001; 1: 470–476.
2. Brickner S. J, Oxazolidinone Antibacterial Agents. Curr. Pharm. Des. 1996; 2: 175–194.
3. Xu G. Y, Zhou Y, Xu M. C, A Convenient Synthesis of Antibacterial Linezolid from (S)-Glyceraldehyde Acetonide. Chin. Chem. Lett. 2006; 17: 302–304.
4. Silva P. S. L, Neto H. M, Sejas L. M, Development and Validation of an Agar Diffusion Assay Stability-Indicating to Determination of the Potency of Linezolid in Tablets in the Presence of Photo degradation Products. Braz. J. Infect. Dis. 2007; 11: 297–299.
5. Reis A. O, Cordeiro J. C. R, Machado A. M. O, Sader H. S, Determination of Linezolid and its Achiral Impurities Using Sweeping Pre concentration by Micellar Capillary Electrophoresis. Braz. J. Infect. Dis. 2001; 5 : 243–251.
6. Abb J, Bacterial Infection Following Refractive Surgery. Diagn. Microbiol. Infect. Dis. 2002; 43: 319–321.
7. Patel R, Rouse M. S, Piper K. E, Steckelberg J. M, Diagn. Linezolid Therapy of Vancomycin-Resistant Enterococcus faecium Experimental Endocarditis. Microbiol. Infect. Dis. 1999; 34: 119– 122.
8. Wilson A. P, Cepeda J. A, Hayman S, Whitehouse T, Singer M, Bellingan G, In vitro Susceptibility of Gram-Positive Pathogens to Linezolid and Teicoplanin and Effect on Outcome in Critically Ill Patients. J. Antimicrob. Chemother. 2006; 58: 470–473.
9. Ba B. B, Binso B. B, Quentin C, Saux M. C, Determination of Linezolid in Growth Media by High-Performance Liquid Chromatography with On-Line Extraction. J. Chromatogr. B. 2007; 854: 104–108.
10. Buerger C, Joukhadar C, Muller M. M, Kloft C, Penetration of Linezolid into Soft Tissues of Healthy Volunteers after Single and Multiple Doses. J. Chromatogr. B. 2003; 796: 155–164.
11. Tobin C. M, Sunderland J, White L. O, MacGowan A. P, Ventriculitis Due to a Hetero Strain of Vancomycin Intermediate Staphylococcus aureus (hVISA) Successful Treatment with Linezolid in Combination with Intraventricular Vancomycin. J. Antimicrob. Chemother. 2001; 48: 605–608.
12. Borner K, Borner E, Lode E. H, Inter. Penetration of Linezolid into Soft Tissues of Healthy Volunteers after Single and Multiple Doses. J. Antimicrob. Agents. 2001; 18: 253–264.
13. Stefanie S, Michael O, Konstantinos A, Heinrich K. G, Markus A. W, Torsten H. T, A Simple Isocratic HPLC Assay to Determine Linezolid Concentrations in Different Biomatrices for In vivo and In vitro Studies. J. Chem. Lab Med. 2007; 45: 1019–1022.
14. Boak L. M, Jian L, Nation R. L, Rayne C. R, High-Performance Liquid Chromatographic Method for Simple and Rapid Determination of Linezolid in Human Plasma. J. Biomed. Chrom. 2005; 20: 782–786.
15. Tobin C. M, Sunderland J, Lovering A. M, MacGowan A. P, A HighPerformance Liquid Chromatography (HPLC) Assay for Linezolid in Continuous Ambulatory Peritoneal Dialysis Fluid (CAPDF). J. Antimicrob. Chemother. 2003; 51: 1041–1042.
16. Cavazos-Rocha N, Vera-Cabrera L, Welsh-Lozano O, Waksman-DeTorres N, Salazar-Cavazos M. L, Simultaneous Determination and Validation of Antimicrobials in Plasma and Tissue of Actinomycetoma by High-Performance Liquid Chromatograph with Diode Array and Fluorescence Detection. J. Pharm. Biomed. Anal. 2007; 43: 1775–1781.
17. Bebaway L. I, Spectrophotometric and HPLC Determination of Linezolid in the presence of Its Alkaline-Induced Degradation Products and Pharmaceutical Tablets. Anal. Lett. 2003; 36: 1141–1161.
18. Lopes C. C. G. O, Salgado H. R. N, Development and Validation ofan Agar Diffusion Assay Stability-Indicating to Determination of the Potency of Linezolid in Tablets in the Presence of Photodegradation Products. Chromatographia. 2009; 69: S129–S135.
19. Reddy K. V. S. R, Rao M. S, Reddy O. G, Suresh T, Moses Babu J, Dubey P. K, Vyas K, Isolation and Characterization of processrelated Impurities in Linezolid. J. Pharm. Biomed. Anal. 30 (2002) 635–642.
20. Michalska K, Pajchel G, Tyski S, Determination of Linezolid and Its Achiral Impurities Using Sweeping Preconcentration by Micellar Capillary Electrophoresis. J. Pharm. Biomed. Anal. 2008; 48: 321–330
21. G. Raveendra Babu, J. Srinivasa Rao, K. Suresh kumar, P. Jayachandra Reddy. Stability Indicating Liquid Chromatographic Method for Aripiprazole. Asian J. Pharm. Ana. 2011; 1(1): 3-7.
22. Akhilesh Gupta, Swati Rawat, Mayuri Gandhi, Jaydeep Singh Yadav. Method Development and Acid Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS. Asian J. Pharm. Ana. 2011; 1(1): 10-13
23. Akhilesh Gupta, Jaydeep Singh Yadav, Swati Rawat, Mayuri Gandhi. Method Development and Hydrolytic Degradation Study of Doxofylline by RP-HPLC and LC-MS/MS. Asian J. Pharm. Ana. 2011; 1(1): 14-18
24. D. Sridharan, Umarani A. Thenmozhi, L. Pavan Kumar, Aswani Dutt Chintalapati, M. Venkata Ramanaiah, Yelika Phanikishore. Development and Validation of UV Spectrophotometric Method of Darifenacin Hydrobromide in Bulk and Tablet Dosage Form. Asian J. Pharm. Ana. 2011; 1(3): 43-45
25. J. Nagamallika, Aruna Mahesh. Development and Validation of Spectrophotometric Method for the Estimation of Aripiprazole in Tablet Dosage Form. Asian J. Pharm. Ana. 2011; 1(3): 46-49
26. Mahmoud M. Sebaiy, Abdullah A. El-Shanawany, Sobhy M. El-Adl, Lobna M. Abdel-Aziz, Hisham A. Hashem. Rapid RP-HPLC Method for Simultaneous Estimation of Norfloxacin and Tinidazole in Tablet Dosage Form. Asian J. Pharm. Ana. 2011; 1(4): 79-84
27. A. Thenmozhi, D. Sridharan, S. Veeramani, M. Palanivelu. An RP-HPLC Method for the estimation of Dexibuprofen in Pharmaceutical Tablet Dosage Form. Asian J. Pharm. Ana. 2011; 1(4): 98-99
28. L. Satyanarayana, S.V. Naidu, M. Narasimha Rao, Reddy Suma Latha. The Estimation of Nilotinib in Capsule dosage form by RP-HPLC. Asian J. Pharm. Ana. 2011; 1(4): 100-102
29. Sharmin Reza Chowdhury, Mahfuza Maleque, Mahbubul Hoque Shihan. Development and Validation of a Simple RP-HPLC Method for Determination of Caffeine in Pharmaceutical Dosage Forms. Asian J. Pharm. Ana. 2012; 2(1): 1-4
30. P. Janaki Pathi, N. Appala Raju. The Estimation of Epalrestat in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2012; 2(2): 49-51
31. Jajow Swapna, Chandaka Madhu, Mallepelli Srivani, M. Sumalatha, Y. Nehalatha, Y. Anusha, Analytical Method Development and Method Validation for the Simultaneous Estimation of Metformin hydrochloride and Pioglitazone hydrochloride in Tablet Dosage Form by RP-HPLC. Asian J. Pharm. Ana. 2012; 2(3): 85-89.