Green analytical method for quantification of Secnidazole in tablets by HPLC-UV
DOI:
https://doi.org/10.22456/2527-2616.89411Keywords:
secnidazole, tablets, HPLC, green analytical chemistry, method validationAbstract
A simple, rapid, economic and green analytical method was validated for the determination of secnidazole in tablets. The aim was to contribute to the green analytical chemistry since it has low use of organic solvent and low production of toxic waste. For the HPLC-UV method, the mobile phase was a mixture of purified water + 0.7 % acetic acid and ethanol (78:22, v/v), flow rate was 1.3 mL min-1 on column CN Phenomenex Luna (250 x 4.60 mm, 5 μm particle size), injection volume was 20 μL with UV detection at 318 nm and retention time of 4.26 minutes. The method was linear over the concentration range of 5-100 μg mL-1 (r = 0.9998) with limits of detection and quantitation of 0.533 e 1.615 μg mL-1, respectively. The precision of the method showed RSD less than 2 %. The accuracy determined by the average recoveries was 99.58 %. The secnidazole tablets were subjected to oxidation, acid, alkaline, neutral and photolysis degradation as stress conditions and the method was considered as indicative of stability. The method is adequate and safe to be a great alternative method in routine quality control analyzes for determination and quantification of secnidazole tablets.
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Tripathi, K. D.; Essentials of Medical Pharmacology; Jaypee Brothers Medical Publishers. 7 ed. Bangladesh, 2013. DOI: https://doi.org/10.5005/jp/books/12021
Acar, J., Petitjean, O., Dubreuil, L. Le secnidazole, un nouveau 5-nitro-imidazolé. Antibiotiques 2005; 7:177- 182. DOI: https://doi.org/10.1016/S1294-5501(05)80186-4
Kazakevich, Y., Lobrutto, R.; HPLC for Pharmaceutical Scientists; John Wiley & Sons: New Jersey, 2007. DOI: https://doi.org/10.1002/0470087951
Dong, M. W. The essence of modern HPLC: advantages, limitations, fundamentals, and opportunities. LCGC Separation Science 2013; 31:472-479.
Al-kaf, A. G. A., Gadkariem, A. E. R., Algaradi, A. A. S. A., Alssmani, T. Development and validation of an RPHPLC method for estimation of secnidazole and its degradation products in tablets. Global Journal of Pharmacy & Pharmaceutical Sciences 2016; 1:555552. DOI: https://doi.org/10.19080/GJPPS.2016.01.555552
Alhalabi, Z., Al-khayat, M. A., Haidar, S. Separation and assay of antiprotozoal imidazole derivates (metronidazole, tinidazole and secnidazole) by RPHPLC. International Journal of Pharmaceutical Sciences Review and Research 2012; 13:13-18.
Elwalily, A. F. M., Abdine, H. H., Razak, O. A., Zamel, S. Spectrophotometric and HPLC determination of secnidazole in pharmaceutical tablets. Journal of Pharmaceutical and Biomedical Analysis 2000; 22:887- 897. DOI: https://doi.org/10.1016/S0731-7085(99)00290-3
Farooqui, N. A., Smith, A. A., Sharma, H. K., Manavalan, R. Analytical method development and validation of secnidazole tablets by RP-HPLC. Journal of Pharmaceutical Sciences and Research 2010; 2:412- 416.
Reddy, K. S., Ramachandra B., Naidu, N. V. S. Validation of RP-HPLC method for the estimation of secnidazole in bulk and its pharmaceutical dosage forms. International Journal of Scientific & Engineering Research 2014; 5:1250-1261.
Sharmin, T., Akter, M., Hossain, M. S. Analytical method development and validation of secnidazole in the tablet dosage form by RP-HPLC method. International Current Pharmaceutical Journal 2016; 5:41-44. DOI: https://doi.org/10.3329/icpj.v5i4.27020
Suryawanshi, P. P., Khan, P. A., Abhyankar, M., Sonawane, S. S., Gide, P. A validated stability-indicating liquid chromatographic method for secnidazole. Journal of innovations in Pharmaceuticals and Biological Sciences 2015; 2:45-52.
Ravi, S. K., Naidu, M. U. R., Sekhar, E. C., Rao, T. R. K., Shobha, J. C., Rani, P. U., Surya, K. J. Rapid and selective analysis of secnidazole in human plasma using high-performance liquid chromatography with ultraviolet detection. Journal of Chromatography B 1996; 691:208- 211. DOI: https://doi.org/10.1016/S0378-4347(96)00419-7
Li, X., Sun, J., Wang, G., Zheng, Y., Yan, B., Xie, H., Gu, Y., Ren, H. Determination of secnidazole in human plasma by high-performance liquid chromatography with UV detection and its application to the bioequivalence studies. Biomedical Chromatography 2007; 21:304-309. DOI: https://doi.org/10.1002/bmc.758
Chierentin, L., Salgado, H. R. N. Development and validationof a simple, rapid and stability-indicating high performance liquid chromatography method for quantification of norfloxacin in a pharmaceutical product. Chromatography Separation Techniques 2013; 4:171-175. DOI: https://doi.org/10.4172/2157-7064.1000171
Tótoli, E. G., Salgado, H. R. N. Development and validation of an economic, environmental friendly and stability-indicating analytical method for determination of ampicillin sodium for injection by RP-HPLC. World Journal of Pharmacy and Pharmaceutical Sciences 2014; 3:1928-1943.
Tótoli, E.G., Salgado, H. R. N. Development, optimization and validation of a green and stabilityindicating HPLC method for determination of daptomycin in lyophilized powder. Journal of AOAC International 2015; 98:1276-1285. DOI: https://doi.org/10.5740/jaoacint.15-039
Rodrigues, D. F., Salgado, H. R. N. Development and validation of a Green analytical method of RP-HPLC for quantification cefepime hydrochloride in pharmaceutical dosage forms: simple, sensitive and economic. Current Pharmaceutical Analysis 2016; 12:306-314. DOI: https://doi.org/10.2174/1573412912666151221210921
Spagnol, C. M.; Isaac, V. L.; Corrêa, M. A.; Salgado, H. R. N. Validation of HPLC-UV assay of caffeic acid in emulsions. Journal of Chromatographic Sciences 2016; 54:305-311. DOI: https://doi.org/10.1093/chromsci/bmv142
Pedroso, T. M.; Medeiros, A. C. D.; Salgado, H. R. N. RP-HPLC x HILIC chromatography for quantifying the ertapenem sodium with a look at green chemistry. Talanta 2016; 160:745-753. DOI: https://doi.org/10.1016/j.talanta.2016.08.016
Figueiredo, A. L.; Kogawa, A. C.; Salgado, H. R. N. Development and validation of an ecological, new and rapid stability-indicating High Performance Liquid Chromatography for quantitative determination of aztreonam in lyophilized powder for injection. Drug Analytical Research 2017; 1:24-30. DOI: https://doi.org/10.22456/2527-2616.73755
Marco, B. A.; Salgado, H. R. N. Development and validation of a green RP-HPLC method for quantification of cefadroxil capsules. World Journal of Pharmacy and Pharmaceutical Sciences 2017; 6:2074- 2091. DOI: https://doi.org/10.20959/wjpps20178-9875
Kogawa, A. C.; Salgado, H. R. N. Ethanolon HPLC: epiphany or nonsense? Acta Scientific Pharmaceutical Sciences 2018; 2:14-15. DOI: https://doi.org/10.2174/1573412913666161213103657
Marco, B. A.; Rechelo, B. S.; Tótoli, E. G.; Kogawa, A. C.; Salgado, H. R. N. Evolution of green chemistry and its multidimensional impacts: a review; Saudi Pharmaceutical Journal DOI 10.1016/j.jsps.2018.07.011.
Watson, D. G. Pharmaceutical analysis, Churchill Livingstone: London, 1999.
Ohannesian, L.; Streeter, A. J. Handbook of pharmaceutical analysis, 3rd ed. Marcel Dekker: New York, 2002. 2009;32: 3425-3431.
Snyder, L. R.; Kirkland, J. J.; Dolan, J. W. Introduction to Modern Liquid Chromatography, John Wiley & Sons: New Jersey, 3rd ed., 2010. DOI: https://doi.org/10.1002/9780470508183
ICH. International Conference on Harmonization. Validation of analytical procedures: text and methodology Q2(R1), 2005.
Inmetro Instituto Nacional de Metodologia de Metrologia, Normalização e Qualidade Industrial. Orientação sobre validação de métodos de ensaios químicos, DOQ-CGCRE-008, 2007.
ISO. International Organization for Standardization. General Requirements for the Competence of Testing and Calibration Laboratories, ISSO/IEC 17025, 1999.
BRASIL. Agência Nacional de Vigilância Sanitária (ANVISA). RDC nº 166, de 24 de Julho de 2017. Dispõe sobre a validação de métodos analíticos e dá outras providências. Diário Oficial da União. Brasília, 25 jul. 2017.
ICH. International Conference on Harmonizaion. Validation of Analytical Procedures: Methodology Q2B, 1996.
Brasil, Agência Nacional de Vigilância Sanitária, RE 899, Guia para validação de métodos analíticos e bioanalíticos, Brasília, 2003.
ICH. International Conference on Harmonization. Validation of analyticalprocedures: text and methodology Q2(R1), 2005.
AOAC - Association of Official Analytical Chemists. Official Methods of Analysis. 17. ed. Gaithesburg: AOAC, 2002.
Youden, W. J.; Steiner, E. H. Statistical Manual of AOAC - Association of Official Analytical Chemistry. Washington: AOAC, 1975.
Kogawa, A. C.; Mendonça, J. N.; Lopes, N. P.; Salgado, H. R. N. Recent advances in the study of the inclusion complex darunavir:β-cyclodextrin by LC-MS. Journal of AOAC International 2016; 99:626-637. DOI: https://doi.org/10.5740/jaoacint.15-0204
Pedroso, T. M.; Salgado, H. R. N. Validation of analytical methodology for quantification of cefazolin sodium pharmaceutical dosage form by high performance liquid chromatography to be applied for quality control in pharmaceutical industry. Brazilian Journal of Pharmaceutical Sciences 2014;50:213-223. DOI: https://doi.org/10.1590/S1984-82502011000100022
Shabir, G. A. Validation of high-performance liquid chromatography methods for pharmaceutical analysis: Understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization. Journal of Chromatography A 2003; 987:57-66. DOI: https://doi.org/10.1016/S0021-9673(02)01536-4
Horwitz, W.; Kamps, L. R.; Boyer, K. W. J. Quality assurance in the analysis of foods and trace constituents. Association of Official Analytical Chemists 1980; 63:1344-1354. DOI: https://doi.org/10.1093/jaoac/63.6.1344
Indian Pharmacopoeia. RajNagar: Ghaziabad, (2007); 3: 1072-1074.
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