A SIMPLE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS ESTIMATION OF AZITHROMYCIN, FLUCONAZOLE AND ORNIDAZOLE IN BULK AND PHARMACEUTICAL DOSAGE FORMS
DOI:
https://doi.org/10.22159/ijpps.2019v11i8.29348Keywords:
Azithromycin, Fluconazole, Ornidazole, Method development, RP-HPLCAbstract
Objective: The objective of the study was to develop and validate a new rapid and more sensitive Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of azithromycin, fluconazole and ornidazole in bulk and pharmaceutical dosage forms.
Methods: Separation was achieved with a cap cell pack C18 column (4.6 x 250 mm, 5μ) with an isocratic mobile phase containing a mixture of acetonitrile and phosphate buffer pH 4.8 [adjusted with ortho-phosphoric acid] (50:50 % v/v) at the flow rate of 1 ml/min and detection was monitored at 210 nm.
Results: The retention time (Rt) of azithromycin, fluconazole and ornidazole were found to be 4.82±0.01, 5.25±0.01 and 6.33±0.01 min respectively. The precision was found with<1.5% of %RSD. The calibration curve was linear over the concentration ranging from 500-1000 µg/ml for azithromycin, 75-150 µg/ml for fluconazole and 375-750 µg/ml for ornidazole with the correlation coefficient (r2) of 0.999. The percentage recovery was found to be within the specified range i.e., 98-102 % for three drugs. Limit of detection (LOD) was found to be 5.810, 1.790 and 4.924 µg/ml, whereas Limit of quantification limits (LOQ) was found to be 9.834, 2.667 and 7.980 µg/ml, respectively.
Conclusion: A simple isocratic liquid chromatographic method was developed and validated for simultaneous estimation of azithromycin, fluconazole and ornidazole in their formulations. Due to its simplicity, rapidness and specificity, it can be applied for routine quality control analysis of these drugs.
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Mubeen G, Prakash V, Somashekar PL, Uvesh K. Spectrophotometric method for determination of ornidazole. Int J ChemTech Res 2009;1:318-21.
Singh A, Sharma PK, Majumdar DK. Development and validation of different UV-spectrometric methods for the estimation of fluconazole in bulk and in solid dosage form. Indian J Chem Tech 2011;18:357-62.
Rele RV, Sawant SA, Patil SS. Simultaneous spectrophotometric estimation of ofloxacin and ornidazole by first-order derivative spectroscopy method in the combined dosage form. Der Chem Sin 2013;4:43-8.
Bhimani S, Sanghvi G, Pethani T, Dave G, Airao V, Sharma T, et al. Development of the UV spectrophotometric method of azithromycin in API and stress degradation studies. Int Lett Chem Phys Astron 2016;68:48-53.
Jayanna BK, Nagendrappa G, Arunkumar, Gowda N. Spectrophotometric estimation of azithromycin in tablets. Indian J Pharm Sci 2012;74:365-7.
Liew KB, Loh OKG, Tan YTF, Kok-khiang P. Development and application of simple HPLC-UV method for fluconazole quantification in human plasma. Int J Pharm Pharm Sci 2012;4:107-11.
Jadhav RS, Kendre PN, Kolhe MH, Lateef SN, Shelke SM, Godge RK. RP-HPLC method for simultaneous estimation of ofloxacin and ornidazole from bulk and tablets. Res J Sci Tech 2009;1:43-6.
Meshtam DB, Bagade SB, Tajne MR. Simple HPLC method for simultaneous estimation of fluconazole and tinidazole in combined dose tablet. J Chromatogr Sci 2009;47:885-8.
Sadasivudu P, Shastri N, Sadanandam M. Development and validation of RP-HPLC and UV methods of analysis for fluconazole in pharmaceutical solid dosage forms. Int J Chem Tech Res 2009;1:1131-6.
Dhandapani B, Thirumoorthy N, Rasheed SH, Kotaiah MR, Anjaneyalu N. Method development and validation for the simultaneous estimation of ofloxacin and ornidazole in tablet dosage form by RP-HPLC. Int J Pharm Sci Res 2010;1:78-83.
Raja MS, Shan SH, Perumal P, Moorthy MTS. RP-HPLC method developed and validation for simultaneous estimation and determination of azithromycin and ambroxol hydrochloride in tablets. Int J Chem Tech Res 2010;2:36-9.
Yanamandra R, Chaudhary A, Bandaru SR, Patro B, Murthy YLN, Ramaiah PA, et al. UPLC method for simultaneous separation and estimation of secnidazole, fluconazole and azithromycin in pharmaceutical dosage forms. E-J Chem 2010;7:S363-71.
Raju CHN, Ramana KV, Rao GD, Thoddi PR. Simultaneous RP-HPLC method development and validation of levofloxacin and ornidazole in combined pharmaceutical dosage forms. Int J Chem Sci 2010;8:2145-52.
Bodepudi C, Bantu S, Reddy MKO, Shanmugasundaram P, Aanandhi MV. Novel RP-HPLC method development and validation of fluconazole and tinidazole in a combined tablet dosage form. Int J Chem Tech Res 2011;3:1309-17.
Venkatesh V, Prabahar AE, Suresh PV, Maheswari CU, Rao NR. RP-HPLC method for simultaneous estimation of azithromycin and ambroxol hydrochloride in tablets. Asian J Chem 2011;23:312-4.
Khattab FI, Ramadan NK, Hegazy MA, Ghoniem NS. Stability-indicating methods for the determination of ornidazole in the presence of its degradate according to ICH guidelines. Pharm Anal Acta 2012;3:1000179.
Dewan I, Amin T, Hossain MdF, Hasan M, Chowdhury SF, Gazi M, et al. Development and validation of a new HPLC method for the estimation of azithromycin in bulk and tablet dosage form. Int J Pharm Res Sci 2013;4:282-6.
Waghule SN, Jain NP, Patani CJ, Patani AC. Method development and validation of HPLC method for determination of azithromycin. Der Pharma Chem 2013;5:166-72.
Sathiyasundar R, Veeramanikandan P, Arcot AS, Rajaganapathy K. Analytical method development and method validation of simultaneous determination of tinidazole and fluconazole by RP-HPLC. Int J Chem Pharm Sci 2014;5:105-9.
Jain SK, Singh M, Jain R, Jain N. Spectrophotometric and RP-HPLC method development and validation for simultaneous estimation of levofloxacin and ornidazole. Int J Pharm Sci Res 2014;5:3370-7.
Krishna VR, Krishna KBM, Babu BH. Development and validation of stability-indicating liquid chromatographic method for the simultaneous estimation of azithromycin, fluconazole and ornidazole in the combined dosage form. Indian J Pharm Sci Res 2014;4:176-86.
Ghode PD, Pawar SP. Stability indicating HPLC method development and validation for the simultaneous determination of azithromycin and ofloxacin in bulk and its dosage forms. Int J Adv Pharm Anal 2015;5:17-22.
Vaidya H, Patel S, Patel D, Pradhan PK, Upadhyay U. Analytical method development and validation of diloxanide furoate and ornidazole in its combined pharmaceutical dosage form. Sch Acad J Pharm 2015;4:398-404.
Arunya A, Kavitha KY. Development and validation of stability-indicating assay method for simultaneous estimation of azithromycin, fluconazole and ornidazole in bulk and its dosage form by RP-HPLC. Am J Pharm Tech Res 2017;7:313-24.
Chepurwar SB, Shirkhedkar AA, Bari SB, Fursule RA, Surana SJ. Validated HPTLC method for simultaneous estimation of levofloxacin hemihydrate and ornidazole in the pharmaceutical dosage form. J Chromatograph Sci 2007;45:531-6.
Ranjane PN, Gandhi SV, Kadukar SS, Bothara KG. HPTLC determination of cefuroxime axetil and ornidazole in combined tablet dosage form. J Chromatograph Sci 2010;48:26-8.
Rote AR, Kumbhoje PA. Development and validation of HPTLC method for simultaneous estimation of gatifloxacin and ornidazole in human plasma. J Chromatograph Separat Techniq 2011;2:1000115.
Gawande VT, Bothara KG, Satija CO. Validated stability-indicating HPTLC method for cefixime and azithromycin with preparative isolation, identification, and characterization of degradation products. Acta Chromatographica 2017;29:1-7.
Xue Min Z, Jie L, Juan G, Quan Sheng Y, Wen Yan W. Determination of azithromycin in human plasma by LC-MS-MS and its pharmacokinetics. Pharmazie 2007;62:255-7.
Yuzuak N, Ozden T, Eren S, Toptan S. Analysis of azithromycin in human plasma by LC–MS–MS. Chromatographia 2007; 66:115-8.
Wu D, Wade KC, Paul DJ, Barrett JS. A rapid and sensitive LC-MS/MS method for determination of fluconazole in human plasma and its application in infants with candida infections. Ther Drug Monit 2009;31:703-9.
Kher GJ, Ram VR, Pandiya GG, Joshi HS. Validated LC method for the simultaneous analysis of cefixime and ornidazole in commercial tablets. Int J ChemTech Res 2012;4:1124-36.
US FDA Guidance for Industry, ICH Q6A, specifications: test procedure and acceptance criteria for new drug substances and new drug products: chemical substances; 1999.
FDA Guidance for Industry-analytical procedures and method validation, chemistry, manufacturing, and controls documentation, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER); 2000.
ICH. Q2 (R1), Validation of analytical procedures: text and methodology, in proceedings of ICH, Geneva, Switzerland; 2005;1:11.
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