Volume : 10, Issue : 03, March – 2023
Title:
14.METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF LEVOFLOXACIN AND AZITHROMYCIN BY RP-HPLC IN TABLET DOSAGE FORM
Authors :
Salgar Pushpa, Dr D Swapna
Abstract :
The aim of the study was method development and validation for simultaneous estimation of levofloxacin and azithromycin by rp-hplc in tablet dosage form. To evaluate system suitability parameters such as retention time, tailing factor and USP theoretical plate count, the mobile phase was allowed to flow through the column at a flow rate of 1.0 ml/min to equilibrate the column at ambient temperature. Analysis was carried out at 265 nm. Chromatographic separation was achieved by injecting a volume of 20 μL of standard into Agilent ZorbaxC18, 250×4.6, 5µ, the mobile phase of composition Phosphate Buffer: Methanol (40:60 % v/v) was allowed to flow through the column at a flow rate of 1.0 ml per minute. The proposed method will be validated as per ICH guidelines. The objective of the proposed work is to develop a new, simple, sensitive, accurate and economical analytical method and validation for the Simultaneous estimation of Levofloxacin, Azithromycin in pharmaceutical dosage form by using HPLC. To validate the developed method in accordance with ICH guidelines for the intended analytical application i.e., to apply the proposed method for analysis of the drug in its dosage form.
Keywords: Levofloxacin, Azithromycin, Method Development, Validation, Accuracy, Precision.
Cite This Article:
Please cite this article in press Salgar pushpaet al, Method Development And Validation For Simultaneous Estimation Of Levofloxacin And Azithromycin By RP-HPLC In Tablet Dosage Form., Indo Am. J. P. Sci, 2023; 10 (03).
Number of Downloads : 10
References:
1. Fabrega A, Madurga S, Giralt E, Vila J: Mechanism of action of and resistance to quinolones. Microb Biotechnol. 2009 Jan;2(1):40-61. doi: 10.1111/j.1751-7915.2008.00063.x. Epub 2008 Oct 13. (PubMed ID 21261881)
2. Fish DN, Chow AT: The clinical pharmacokinetics of levofloxacin. Clin Pharmacokinet. 1997 Feb;32(2):101-19. doi: 10.2165/00003088-199732020-00002. (PubMed ID 9068926)
3. FDA Approved Drug Products: Levaquin (levofloxacin) oral tablets
4. Noedl H, Krudsood S, Chalermratana K, Silachamroon U, Leowattana W, Tangpukdee N, Looareesuwan S, Miller RS, Fukuda M, Jongsakul K, Sriwichai S, Rowan J, Bhattacharyya H, Ohrt C, Knirsch C: Azithromycin combination therapy with artesunate or quinine for the treatment of uncomplicated Plasmodium falciparum malaria in adults: a randomized, phase 2 clinical trial in Thailand. Clin Infect Dis. 2006 Nov 15;43(10):1264-71. Epub 2006 Oct 12. [Article]
5. Peters DH, Friedel HA, McTavish D: Azithromycin. A review of its antimicrobial activity, pharmacokinetic properties and clinical efficacy. Drugs. 1992 Nov;44(5):750-99. doi: 10.2165/00003495-199244050-00007. [Article]
6. McMullan BJ, Mostaghim M: Prescribing azithromycin. Aust Prescr. 2015 Jun;38(3):87-9. Epub 2015 Jun 1. [Article]
7. Fohner AE, Sparreboom A, Altman RB, Klein TE: PharmGKB summary: Macrolide antibiotic pathway, pharmacokinetics/pharmacodynamics. Pharmacogenet Genomics. 2017 Apr;27(4):164-167. doi: 10.1097/FPC.0000000000000270. [Article]
8. Khedr A, Sheha M, Quantitative thin-layer chromatographic method of analysis of azithromycin in pure and capsule forms, J. Chromatogr. Sci., 41, 2003, 10-16.
9. 5R. Yanamandra, A. Chaudhary, S. Bandaru, Patro B, MURTHY YLN, RAMAIAH P, SASTRY CSP, UPLC Method for simultaneous separation and estimation of secnidazole, fluconazole and azithromycin in pharmaceutical dosage forms, E-journal of chemistry, 7, 2010, S363-S371.
10. Devia ML, Chandrasekharb KB, A validated stability-indicating RP-HPLC method for levofloxacin in the presence of degradation products, its process related impurities and identification of oxidative degradant, J. Pharmaceut. Biomed., 50, 2009, 710-717.
11. Kumar TM, Gurrala S, Rao VJ, Sambasiva Rao KRS, Development and validation of HPLC-UV method for the estimation of levofloxacin in human plasma, International journal of pharmacy and pharmaceutical sciences, 3, 2011, 247-250.
12. Patel P, Shah H, Patel K, Patel M, Development and validation of spectrophotometric methods for simultaneous estimation of cefixime trihydrate and levofloxacin hemihydrate in their combined tablet dosage forms, International journal of pharmaceutical research and bio science, 1, 2012, 502-515.
13. Kavar RC, Savaliya BM, Lakkad AJ, Soriya SV, Kapuriya KG, Faldu SD, Q-absorbance ratio spectrophotometric method for the simultaneous estimation of cefpodoxime proxetil and levofloxacin hemihydrate in their combined dosage forms, International bulletin of drug research, 2, 2013, 22-30.
14. 1Dhanhukiya VR, Tiwari PS, Godavariya VD, Development and validation of RP-HPLC method for simultaneous estimation of levofloxacin hemihydrates and cefixime trihydrate in marketed formulation, International research journal of pharmacy, 4, 2013, 81-83.
15. El-Shanawany AA, El-Adl SM, Abdel-Aziz LM, Hashem HA, Sebaiy MM, Rapid RP-HPLC Method for simultaneous estimation of levofloxacin hydrochloride, lomefloxacin hydrochloride, gatifloxacin and sparfloxacin, Asian. J. Research. chem., 4, 2011, 1688-1694.
16. Chepurwar SB, Shirkhedkar AA, Bari SB, Fursule RA, Surana SJ, Validated HPTLC method for simultaneous estimation of levofloxacin hemihydrate and ornidazole in pharmaceutical dosage form, J. Chromatogr. Sci., 45, 2007, 531-536.
17. Raja MS, Shan SH, Perumala P, Moorthy MTS, RP-HPLC method development and validation for the simultaneous estimation of azithromycin and ambroxol hydrochloride in tablets, International journal of pharmtech research., 2, 2007, 36-39.