Green method for quantification of clindamycin in capsules by National Environmental Methods Index, Eco-Scale Assessment and Analytical GREEnness Metric
DOI:
https://doi.org/10.22456/2527-2616.147142Keywords:
clindamycin, Eco-Scale Assessment, National Environmental Methods Index, Analytical GREEnnessAbstract
Clindamycin (CLIN) is an antibiotic derived from lincosamide, produced from Streptomyces lincolnensis. Studies in the literature demonstrate that the evaluation of this drug, although effective, predominantly uses analytical conditions with the use of toxic solvents, which are against the principles of Green Analytical Chemistry (GAC). In this context, the objective was to develop and validate an eco-friendly method by spectrophotometry in the ultraviolet (UV) region for the quantitative evaluation of CLIN in capsules. In addition, the proposed method was evaluated for greenness by the National Environmental Methods Index (NEMI), Ecological Scale Assessment (ESA) and Analytical GREEnness Metric (AGREE). Purified water and ethanol (50:50, v/v), quartz cuvette and wavelength of 318 nm and potassium permanganate as an oxidizing agent were used. The method was linear in the range of 0.5 to 5 µg mL-1 (0.9998), precise (RSD < 5 %); selective through spectral overlap and forced degradation; accurate (99.85%); robust to changes in wavelength and cuvette capacity; content analysis was of 102.55 % and NEMI presented all 4 green quadrants; ESA, score of 79, which characterizes an excellent green analysis; and AGREE score of 0.8, thus characterizing it as a green method through the 12 GAC principles. The method was developed and validated and can be used for quantitative evaluation of CLIN in capsules. Furthermore, the method was considered green through the greenness profiling tools NEMI, ESA and AGREE.
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Luchian I, Goriuc A, Martu MA, Covasa M. Clindamycin as alternative option in optimizing periodontal therapy. Int. J. Anbitiot. 2021; 10:814-826. DOI: https://doi.org/10.3390/antibiotics10070814 DOI: https://doi.org/10.3390/antibiotics10070814
Brazilian Pharmacopeia, 6th Ed., ANVISA, Brasília, 2019
United States Pharmacopeia, United States Convention Inc., Rockville, MD, 2020.
Álvarez LA, Sije GV, Desment S, Metsemakes WJ, Spriet I, Allegaert K, Rozenski J. Ways to improve insights into clindamycin pharmacology and pharmacokinetics tailored to practice. Int. J. Anbitiot 2022; 11:701-725. DOI: https://doi.org/10.3390/antibiotics11050701. DOI: https://doi.org/10.3390/antibiotics11050701
Kadhim Dakhil IA, Mahdi ZH. An Overview on the recent technologies and advances in drug delivery of poorly water-soluble drugs. J. Pharm. Sci. 2019; 19(4):180-195. DOI: https://doi.org/10.32947/ajps.v19i4.649. DOI: https://doi.org/10.32947/ajps.v19i4.649
Tehrani M, Namadchian M, Vatan SF, Souri E. Derivative spectrophotometric method for simultaneous determination of clindamycin phosphate and tretinoin in pharmaceutical dosage forms. DARU J. Pharm. Sci. 2013; 21:1-7. DOI: https://doi.org/10.1186/2008-2231-21-29. DOI: https://doi.org/10.1186/2008-2231-21-29
Muthukumar S, Kathram S, Navanethan J, Selvakumar D, Banji, D. Method development and validation of RP-HPLC method for simultaneous determination of clindamycin phosphate and clotrimazole in soft gelatin vaginal suppositories. IJPT 2013; 4:270-275. DOI: 10.21276/ijpt DOI: https://doi.org/10.21276/ijpt
Wu GK, Gupta A, Khan MA, Faustino PJ. Development and application of a Validated HPLCmethod for thedetermination of clindamycin palmitate hydrochloride in marketed drug products: Anoptimization of the current USP methodology for assay. JASMI 2013; 3:202-211. DOI: http://dx.doi.org/10.4236/jasmi.2013.34026. DOI: https://doi.org/10.4236/jasmi.2013.34026
Chaudhary AM, Modi J, Shaikh M. RP-HPLC method development and validation for simultaneous estimation of clindamycin phosphate and nicotinamide in pharmaceutical dosage form. Int. Bull. Drug Res. 2014; 4:160-174.
Khatri RH, Patel RB, Patel MR. A new RP-HPLC method for estimation of clindamycin and adapalene in gel formulation: Development and validation consideration. Thai J. Pharm. Sci. 2014; 38:44-48. DOI: https://doi.org/10.56808/3027-7922.1969
Modi PB, Shah NJ. Novel stability-indicating RP-HPLC method for the simultaneous estimation of clindamycin phosphate and adapalene along with preservatives in topical gel formulations. Sci. Pharm 2014; 82:799-814. DOI: https://doi.org/10.3797/scipharm.1404-01 DOI: https://doi.org/10.3797/scipharm.1404-01
Prava VRK, Seru G. RP-HPLC method development and validation for the simultaneous determination of clindamycin and miconazole in pharmaceutical dosage forms. Pharm. Methods 2014; 5:56-60. DOI: 10.5530/PHM.2014.2.3
Seethalakshmi N, Chenthilnathan A, Rama K. RP-HPLC method development and validation for simultaneous estimation of metronidazole, clindamycin phosphate and clotrimazole in combined pharmaceutical dosage forms. Int. Res. J. Pharm. Appl. Sci. 2014; 4:67-77.
Sun Q, Li Y, Qin L. Isolation and identification of two unknown impurities from the row material of clindamycin hydrochloride. J. Sep. Sci. 2014; 37:2682-2687. DOI: https://doi.org/10.1002/jssc.201400166 DOI: https://doi.org/10.1002/jssc.201400166
Wahba MEK, El-Enany N, Belal, F. Application of the Stern–Volmer equation for studying the spectrofluorimetric quenching reaction of eosin with clindamycin hydrochloride in its pure form and pharmaceutical preparations. Anal. Methods 2015; 7:10445-10451. DOI: https://doi.org/10.1039/C3AY42093K DOI: https://doi.org/10.1039/C3AY42093K
Rajendar L, Potnuri NR. A stability indicating RP-HPLC method for the simultaneous estimation of metronidazole, clindamycin and clotrimazole in bulk and their combined dosage form. World J. Pharm. Sci. 2015; 3:93-103. DOI: 10.54037/WJPS DOI: https://doi.org/10.54037/WJPS
Akula G, Saibabu V, Phanindra SS, Nirmal R, Suddagoni S, Jaswanth A. RP-HPLC method development and validation for the simultaneous estimation of miconazole and clindamycin in pharmaceutical dosage forms. Sch. Acad. J. Pharm. 2017; 6:27-33. DOI: 10.21276/sajp.2017.6.4
Dedić M, Bečić E, Imamović B, Žiga N. Determination of clindamycin hydrochloride content in 1% clindamycin lotion. Glas. Hem. Tehnol. Bosne Herceg. 2018; 50:49-54.
Affas S, Sakur A.A. Validated green spectrophotometric kinetic method for determination of clindamycin hydrochloride in capsules. BMC Chem 2021; 29:1-7. DOI: https://doi.org/10.1186/s13065-021-00755-0 DOI: https://doi.org/10.1186/s13065-021-00755-0
Sarfraz S, Hussain S, Javed M, Raza A, Iqbal S, Alrbyawi H, Aljazzar SO, Elkaeed EB, Somaily HH, Pashameah R, Alzahrani E, Farouk AE. Simultaneous HPLC determination of clindamycin phosphate, tretinoin, and preservatives in gel dosage form using a novel stability-indicating method. Inorganics 2022; 10:1-15. DOI: https://doi.org/10.3390/inorganics10100168 DOI: https://doi.org/10.3390/inorganics10100168
Leanpolchareanchai J, Jumniansuk N, Saesoul C, Sukthongchaikool R, Phechkrajang C. Quantitative determination of clindamycin phosphate in gel preparation using PLSR Model. Anal. Bioanal. Chem. Res. 2023; 10:395-402. DOI: https://doi.org/10.22036/abcr.2023.386693.1890
Rodrigues DF, Salgado HRN. Development and validation of a green analytical method of RP-HPLC for quantification of Cefepime hydrochloride in pharmaceutical dosage form: Simple, sensitive and economic. Curr. Pharm. Anal. 2016; 12:306-314. DOI: http://dx.doi.org/10.2174/1573412912666151221210921 DOI: https://doi.org/10.2174/1573412912666151221210921
Al-Momani IF, Al-Kilani LMZ. Chromatographic and spectrophotometric determination of clindamycin in pharmaceutical products. Ind J. of Chem. 2024; 24:845-854. DOI: https://doi.org/10.22146/ijc.91599 DOI: https://doi.org/10.22146/ijc.91599
EL-Yazbi AF, Blaih MS. Spectrophotometric and titrimetric determination of clindamycin hydrochloride in pharmaceutical preparations. Analyst 1993; 118:577-579. DOI: https://doi.org/10.1039/an9931800577
Kogawa AC, Mendonça JN, Lopes NP, Salgado HRN. Eco-friendly pharmaceutical analysis of rifaximin in tablets by HPLC-MS and microbiological turbidimetry. J. Chromatogr. Sci. 2021; 59(7):597-605. DOI: https://doi.org/10.1093/chromsci/bmab044 DOI: https://doi.org/10.1093/chromsci/bmab044
Trindade MT, Kogawa AC, Salgado HRN. A clean, sustainable and stability-indicating method for the quantification of ceftriaxone sodium in pharmaceutical product by HPLC. J. Chromatogr. Sci. 2021; 60(3):260-266. DOI: https://doi.org/10.1093/chromsci/bmab078 DOI: https://doi.org/10.1093/chromsci/bmab078
De Oliveira AS, De Oliveira NRL, De Oliveira Neto JR, Tavares LL, Kogawa AC. Green method for evaluation of marbofloxacin tablets by HPLC and evaluation of interchangeability with UV and turbidimetric methods. J. AOAC Int. 2023; 106(6):1432-1437. DOI: https://doi.org/10.1093/jaoacint/qsad102 DOI: https://doi.org/10.1093/jaoacint/qsad102
Silva TAC, Da Silva Júnior JR, Kogawa AC. A new, ecological and stability-indicating method by HPLC for the quantification of moxifloxacin in tablets. Curr. Green. Chem. 2023; 10(2):165-173. DOI: https://doi.org/10.2174/2213346110666230331085433 DOI: https://doi.org/10.2174/2213346110666230331085433
Ghidini LF, Kogawa AC, Salgado HRN. Eco-friendly green liquid chromatographic for determination of doxycycline in tablets and in the presence of its degradation products. Drug Anal. Res. 2018; 2:49-55. DOI: https://doi.org/10.22456/2527-2616.89412 DOI: https://doi.org/10.22456/2527-2616.89412
Lima JGS, Kogawa AC, Salgado HRN. Green analytical method for quantification of secnidazole in tablets by HPLC-UV. Drug Anal. Res. 2018; 2:20-26. DOI: https://doi.org/10.22456/2527-2616.89411
Aken VK, Strekowski L, Patuny L. Eco-Scale, a semi-quantitative tool to select an organic preparation based on economic and ecological parameters. J.Org. Chem 2006; 2:1-7. DOI: https://doi.org/10.1186/1860-5397-2-3 DOI: https://doi.org/10.1186/1860-5397-2-3
Galuszka A, Migaszewski ZM, Konieczka P, Namiesnik J. Analytical Eco-Scale for assessing the greenness of analytical procedures. TrAC 2012; 37:61-72. DOI: https://doi.org/10.1016/j.trac.2012.03.013 DOI: https://doi.org/10.1016/j.trac.2012.03.013
Mohamed D, Fouad MM. Application of NEMI, Analytical Eco-Scale and GAPI tools for greenness assessment of three developed chromatographic methods for quantification of sulfadiazine and trimethoprim in bovine meat and chicken muscles: Comparison to greenness profile of reported HPLC methods. Microchem J 2020; 157:104873-104886. DOI:https://doi.org/10.1016/j.microc.2020.104873 DOI: https://doi.org/10.1016/j.microc.2020.104873
Pena-Pereira F, Wojnowski W, Tobiszewski M. AGREE-Analytical GREEnness metric approach and software. Anal. Chem. 2020; 92:10076-10082. DOI: https://doi.org/10.1021/acs.analchem.0c01887 DOI: https://doi.org/10.1021/acs.analchem.0c01887
Kogawa AC, Salgado HRN. Impurities and forced degradation studies: A review. Curr. Pharm. Anal. 2016; 12:18-24. DOI: https://doi.org/10.2174/1573412911666150519000155
Khan AAP, Mohd A, Bano S, Siddiqi KS, Asiri AM. Spectrophotometric methods for the determination of ampicillin by potassium permanganate and 1-chloro-2, 4-dinitrobenzene in pharmaceutical preparations. Arab. J. Chem. 2015; 8:255-263. DOI: https://doi.org/10.1016/j.arabjc.2012.04.033 DOI: https://doi.org/10.1016/j.arabjc.2012.04.033
International Conference on Harmonization (2005) Requirements for registration of pharmaceuticals for human use. Validation of analytical procedures: Text and Methodology Q2 (R1). Switzerland, ICH Steering Committee.
Brazillian health survelliance agency- ANVISA. Resolution of Collegiate board – RDC 166, Brazil 2017. Available from: https://abracro.org.br/pdfs/05_RDC16624Jul2017_validacao_metodos_analiticos.pdf
Lee DG, Shaabani A. Potassium permanganate oxidation of organic compounds. Synt Commun, 2005; 35571-580. DOI: https://doi.org/10.1002/chin.200531046
Özyiğit F, Yildiz E, Çetiner M, Coşgun S. A rare case of poisoning: potassium permanganate toxicity. Turk J. Anaesthesiol. Reanim 2020; 48:248-250. DOI: https://doi.org/10.5152/TJAR.2019.04828
Abdel-Kader DA, Hashem EY. Spectrophotometric determination of Metronidazole antibacterial drug via oxidation with alkaline potassium permanganate. Spect. Acta Part A: Mol and Bio. Spect. 2021; 259:1-6. DOI: https://doi.org/10.1016/j.saa.2021.119858 DOI: https://doi.org/10.1016/j.saa.2021.119858
Oesterling TO. Aqueous stability of clindamycin. J. Pharm. Sci. 1970; 59:63-67. DOI: https://doi.org/10.1002/jps.2600590110
Lustosa IA, Gil ES, Kogawa AC. Analytical aspects for evaluation of pharmaceutical products: a mini-review. Curr Pharm Anal 2022; 18:909-918. DOI: https://doi.org/10.2174/1573412918666220928120332
Association of Official Analytical Chemists: Official Methods of Analysis, 15th ed., AOAC: Gaithesburg, 2002.
Horwitz W, Kamps LR, Boyer KW. Quality assurance in the analysis of foods for trace constituents. J AOAC Int 1980; 63:1344-1354. DOI: https://doi.org/10.1093/jaoac/63.6.1344
Sinzervinch A, Torres IMS, Kogawa AC. Tools to evaluate the eco-efficiency of analytical methods in the context of green and white analytical chemistry: a review. Curr. Pharm. Des. 2023; 29:2442-2449. DOI: https://doi.org/10.2174/0113816128266396231017072043
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