Development and validation of high-performance liquid chromatography method for determination of clarithromycin in pharmaceutical tablets.
capillary electrophoresis
clarithromycin
high-performance liquid chromatography
microbiological assay
pharmaceutical formulations
Journal
Journal of separation science
ISSN: 1615-9314
Titre abrégé: J Sep Sci
Pays: Germany
ID NLM: 101088554
Informations de publication
Date de publication:
Nov 2023
Nov 2023
Historique:
revised:
21
07
2023
received:
11
06
2023
accepted:
19
08
2023
medline:
9
11
2023
pubmed:
31
8
2023
entrez:
31
8
2023
Statut:
ppublish
Résumé
Clarithromycin is a very important macrolide antibiotic used to treat bacterial infections in human and veterinary medicine. This study reports the development and validation of cost-effective, simple, precise, accurate, and robust high-performance liquid chromatography (HPLC) for the determination of clarithromycin (CLA) in tablets. Reversed-phase chromatography was conducted using a standard column at 55°C with ultraviolet detection at 215 nm. A mobile phase consisting of acetonitrile -2-methyl-2-propanol -potassium phosphate buffer was used at a flow rate of 1.0 mL/min. The proposed method displayed good linearity, precision, accuracy, robustness, and specificity. The present HPLC was compared with capillary electrophoresis and bioassay methods and the results indicated that there was no significant difference between these methods. Moreover, the obtained results demonstrated the validity of the isocratic HPLC, which allows reliable quantitation of CLA in pharmaceutical samples. Thus, it can be used as a substitute alternative methodology for the routine quality control of this medicine, in situations where other methods are less accessible in the laboratory.
Identifiants
pubmed: 37650313
doi: 10.1002/jssc.202300424
doi:
Substances chimiques
Clarithromycin
H1250JIK0A
Tablets
0
Anti-Bacterial Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
e2300424Informations de copyright
© 2023 Wiley-VCH GmbH.
Références
Omura S. Macrolide antibiotics, chemistry, biology, and practice. 2nd ed. London: Academic Press; 2002.
Brunton L, Lazo J, Parker K. Goodman and Gilman's the pharmacological basis of therapeutics. 11th ed. New York: McGraw Hill Professional; 2005.
Nakagawa Y, Itai S, Yoshida T, Nagai T. Physicochemical properties and stability in the acidic solution of a new macrolide antibiotic, clarithromycin, in comparison with erythromycin. Chem Pharm Bull. 1992;40:725-8.
Rajinikanth PS, Mishra B. Floating in situ gelling system for stomach site specific delivery of clarithromycin to eradicate H., pylori. J Controlled Release. 2008;125:33-41.
Mahmoudi A, Fourar REA, Boukhechem MS, Zarkout S. Microbiological assay for the analysis of certain macrolides in pharmaceutical dosage forms. Int J Pharm. 2015;491:285-91.
Shah J, Jan R, Manzour R. Extractive Spectrophotometric methods for the determination of clarithromycin in pharmaceutical formulations using bromothymol blue and cresol red. J Chin Chem Soc. 2008; 55(5): 1107-12.
Khashaba PY. Spectrofluorimetric analysis of certain macrolide antibiotics in bulk and pharmaceutical formulations. J Pharm Biomed Anal. 2002;27:923-32.
Kwiecień A, Krzek J, Gądek M. Simultaneous identification and quantitative determination of azithromycin, clarithromycin, roxithromycin, spiramycin and troleandomycin by thin-layer chromatography and densitometry. Acta Chromatographica. 2013;26:657-70.
Ghoneim MM, El-Attar MA. Adsorptive stripping voltammetric determination of antibiotic drug clarithromycin in bulk form, pharmaceutical formulation and human urine. Chemia Analityczna. 2008;53:689-702.
Vajdle O, Guzsvány V, Škorić D, Csanádi J, Petković M, Avramov-Ivić M, et al. Voltammetric behavior and determination of the macrolide antibiotics azithromycin, clarithromycin and roxithromycin at a renewable silver-amalgam film electrode. Electrochim Acta. 2017;229:334-44.
Yu T, Du Y, Chen J, Xu G, Yang K, Zhang Q, et al. Study on clarithromycin lactobionate based dual selector systems for the enantioseparation of basic drugs in capillary electrophoresis. J Sep Sci. 2015;38(16):2900-6.
Paul P, Duchateau T, Sänger-van de Griend C, Adams E, Van Schepdael A. Capillary electrophoresis with capacitively coupled contactless conductivity detection method development and validation for the determination of azithromycin, clarithromycin and clindamycin. J Sep Sci. 2017;40:3535-44.
Pappa-Louisi A, Papa-Georgiou A, Zitrou A, Sotiropoulos S, Georgarakis E, Zougrou F. Study on the electrochemical detection of the macrolide antibiotics clarithromycin and roxithromycin in reversed-phase high-performance liquid chromatography. J Chromatogr B. 2001;755:57-64.
Taninaka C, Ohtani H, Hanada E, Kotaki H, Sato H, Iga T. Determination of erythromycin, clarithromycin, roxithromycin and azithromycin in plasma by high performance liquid chromatography with amperometric detection. J Chromatogr B. 2000;738(2):405-11.
Choi SJ, Kim SB, Lee HY, Na DH, Yoon YS, Lee SS, et al. Column-switching high performance liquid chromatographic determination of clarithromycin in human plasma with electrochemical detection. Talanta 2001;54(2):377-82.
Jia S, Song IG, Jeong KM, Li J, Park JH, Lee J, et al. Combination of a sub-3 μm superficially porous particle packed column with charged aerosol detection for the simple and sensitive measurement of nine macrolides in human urine. J Sep Sci. 2014;37(20):2837-43.
Hendenmo M, Eriksson BM. Liquid chromatographic determination of the macrolide antibiotics roxithromycin and clarithromycin in plasma by automated solid phase extraction and electrochemical detection. J Chromatogr A. 1995;692(1-2):161-6.
Song X, Zhou T, Li J, Su Y, Xie J, He L. Determination of macrolide antibiotics residues in pork using molecularly imprinted dispersive solid-phase extraction coupled with LC-MS/MS. J Sep Sci. 2018;41(5):1138-48.
Wei J, Shen A, Yan J, Jin G, Yang B, Guo Z, et al. Separation analysis of macrolide antibiotics with good performance on a positively charged C18HCE column. J Sep Sci. 2016;39(6):1073-81.
da Costa RP, Spisso BF, Pereira MU, Monteiro MA, Ferreira RG da Nóbrega AW. Innovative mixture of salts in the quick, easy, cheap, effective, rugged, and safe method for the extraction of residual macrolides in milk followed by analysis with liquid chromatography and tandem mass spectrometry. J Sep Sci. 2015;38(21):3743-9.
Wang J, Ling Y, Zhou W, Li D, Deng Y, Yang X, et al. Targeted analysis of six emerging derivatives or metabolites together with 25 common macrolides in milk using quick, easy, cheap, effective, rugged and safe extraction and ultra-performance liquid chromatography quadrupole/electrostaticfield orbitrap mass spectrometry. J Sep Sci. 2020;43(19):3719-34.
Sastre Toraño J, Guchelaar H-J. Quantitative determination of the macrolide antibiotics erythromycin, roxithromycin, azithromycin and clarithromycin in human serum by high-performance liquid chromatography using pre-column derivatization with 9-fluorenylmethyloxycarbonyl chloride and fluorescence detection. J Chromatogr B. 1998;720:89-97.
Li W, Jia H, Zhao K. Determination of clarithromycin in rat plasma by HPLC-UV method with pre-column derivatization. Talanta 2007;71:385-90.
Abuga KO, Chepkwony HK, Roets E, Hoogmartens J. A Stability-indicating HPLC method for the separation of clarithromycin and its related substances in bulk Samples. J Sep Sci. 2001;24:849-55.
Kanfer I, Skinner MF, Walker RB. Analysis of macrolide antibiotics. J Chromatogr A. 1998;812:255-86.
Javanbakht F, Afshar Mogaddam MR, Nemati M, Farajzadeh MA. Dispersive solid phase extraction of metronidazole and clarithromycin from human plasma using a β-cyclodextrin grafted polyethylene polymer composite. J Sep Sci. 2023;46(8):2200696.
Mahmoudi A, De Francia S, Boukhechem M, Pirro E. Quantification of three macrolide antibiotics in pharmaceutical lots by HPLC: Development, validation and application to a simultaneous separation. Br J Pharm. 2016;1:63-73.
Mahmoudi A. Efficient and simple HPLC method for spiramycin determination in urine samples and in pharmaceutical tablets. Sep Sci Plus. 2018;1(4):253-60.
Mahmoudi A, Boukhechem M. Simplified HPLC method for simultaneous determination of erythromycin and tretinoin in topical gel form. Sep Sci Plus. 2020;3(4):86-93.
ICH-Guidelines Validation of Analytical Procedures, Methodology International Council on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use, Geneva, Switzerland 2011.
Commissariat à l'Energie Atomique. Statistique appliquée à l'exploitation des mesures, I and II. Paris: Masson; 1978.
Chepkwony HK, Vermaelen A, Roets E, Hoogmartens J. Development and validation of a reversed phase liquid chromatographic method for analysis of spiramycin and related substances. Chromatographia. 2001;54:51-6.
Schellinger AP, Carr PW. Isocratic and gradient elution chromatography: A comparison in terms of speed, retention reproducibility and quantitation. J Chromatogr A. 2006;1109(2):253-66.
Ermer J. In: Ermer J, Miller JHM, editors. Performance parameters, calculations and tests. Method validation in pharmaceutical analysis: A guide to best practice. Weinheim: Wiley-VCH; 2005. pp. 21-101.
Ermer J, Ploss HJ. Validation in pharmaceutical analysis. Part II: Central importance of precision to establish acceptance criteria and for verifying and improving the quality of analytical data. J Pharm Biomed Anal. 2005; 37: 859-70.
Ahuja S, Dong MW. Handbook of pharmaceutical analysis by HPLC. In: Lister AS, editor. Validation of HPLC methods in pharmaceutical analysis. California: Elsevier Inc.; 2005. pp. 191-217.
Dejaegher B, Vander Heyden Y. Ruggedness and robustness testing. J Chromatogr A. 2007; 1158: 138-57.
Vander Heyden Y, Massart DL. Review of the use of robustness and ruggedness in analytical chemistry. In: Smilde A, de Boer J, Hendriks M, editors. Robustness of analytical methods and pharmaceutical technological products. Amsterdam: Elsevier; 1996. pp. 79-147.
Council of Europe. European Pharmacopoeia. 11th ed. Strasbourg, France: EDQM, Council of Europe; 2023.
Perez C, Rani M, Phan T. Optimization of high-performance liquid chromatography parameters for purification of Oligonucleotide-A. Am J Anal Chem. 2022;13:39-50.
Kul A, Ozdemir M, Sagirli O. Pharmacokinetic study of clarithromycin in human breast milk by UPLC-MS/MS. J Pharm Biomed Anal. 2022;208:114438.