Unique green chromatography method for the determination of serotonin receptor antagonist (Ondansetron hydrochloride) related substances in a liquid formulation, robustness by quality by design-based design of experiments approach.
analytical eco-scale
design of experiments
green analytical procedure index
ondansetron hydrochloride
quality by design
Journal
Journal of separation science
ISSN: 1615-9314
Titre abrégé: J Sep Sci
Pays: Germany
ID NLM: 101088554
Informations de publication
Date de publication:
May 2022
May 2022
Historique:
revised:
09
03
2022
received:
10
12
2021
accepted:
09
03
2022
pubmed:
14
3
2022
medline:
25
5
2022
entrez:
13
3
2022
Statut:
ppublish
Résumé
Serotonin receptor antagonist drug Ondansetron hydrochloride injectable formulation containing all related substances was identified and quantified by a single, simple, sensitive, eco-friendly, and green high-performance liquid chromatography method. The disseverment of all impurities was achieved with the Discovery Cyano (250 × 4.6) mm, 5 μm column. The gradient program was composed of pH 5.7 phosphate buffer as mobile phase A and acetonitrile as mobile phase B. The flow rate, column compartment temperature, and detection wavelengths were 0.9 mL/min, 30°C, and 216 nm, respectively. The method was validated as per current regulatory guidelines. The obtained %relative standard deviation for the precision results was between 0.55 and 2.72% for all impurities. The correlation coefficient values from the linearity experiment for impurities and analyte were more than 0.995. The accuracy results were obtained between 88.4 and 113.0% for all impurities. Both sample and standard solutions showed 24 h stability at benchtop and refrigerator conditions. All impurities and analytes met the specificity and mass balance for all forced degradation conditions. Quality-by-design-based design of experiments was utilized to establish the method's robustness. Method greenness was assessed by using the current advanced tool green analytical procedure index, National Environmental Methods Index, and analytical eco-scale.
Identifiants
pubmed: 35279949
doi: 10.1002/jssc.202100979
doi:
Substances chimiques
Serotonin Antagonists
0
Ondansetron
4AF302ESOS
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1711-1726Informations de copyright
© 2022 Wiley-VCH GmbH.
Références
Pang DC. American Association of Pharmaceutical Scientists. Arlington: Virginia 22201; 2001.
USP 43 NF 38 United States Pharmacopeial Convention. Rockville, MD: Drug product; 2021.
USP 43 NF 38 United States Pharmacopeial Convention. Rockville, MD: Drug substance; 2021.
European Indian pharmacopoeia 10.0. Strasbourg, France: Council of Europe; 2021.
Patra S, Choudhury AA, Kar RK, Barik BB. Spectrophotometric method for ondansetron hydrochloride. Indian J Pharm Sci. 2007;69:840-1.
Anitha G, Pandey VP. Enantioseparation and purity determination of ondansetron by amylose based chiral HPLC method: a chemometric approach. Int J Pharm Sci Rev Res. 2018;9:706-16.
Kannappan V, Kanthiah S. Enantiopurity assessment of chiral switch of ondansetron by direct chiral HPLC. Chromatographia 2017;80:229-36.
Mohamed AM, Mohamed NA, Ali AM. Simultaneous determination of three 5-HT3 receptor antagonists accompanied by stability study using thin-layer chromatography-densitometry. Chromatogr Mod TLC. 2019;32:285-94.
Zheng HS, Pan W, Wang Y, Mao SR, Bi DZ. Determination of ondansetron hydrochloride in human plasma by HPLC. Chin J Pharm. 2002;33:603-4.
Bauer S, Störmer E, Kaiser R, Tremblay PB, Brockmöller J, Roots I. Simultaneous determination of ondansetron and tropisetron in human plasma using HPLC with UV detection. Biomed Chromatogr. 2002;16:187-90.
Ding P, Xu H, Wei G, Zheng J. Microdialysis sampling coupled to HPLC for transdermal delivery study of ondansetron hydrochloride in rats. Biomed Chromatogr. 2000;14:141-4.
King DT, Stewart JT, Venkateshwaran TG. HPLC determination of propofol-thiopental sodium and propofol-ondansetron mixtures. J Liq Chromatogr Relat Technol. 1996;19:2285-94.
Suneetha A, Priya TC. RP-HPLC method for simultaneous estimation of paracetamol and ondansetron in bulk and oral suspension. J Pharm Res. 2014;13:106-10.
Shen YL, Feng F. Study on pharmacokinetic interaction of Ondansetron and Chlorpromazine in rat. Chin Pharm J. 2008;43:771-775.
Zhong DF. Enantiomeric separation of trimebutinelafutidine and ondansetron by HPLC using chiral stationary phase. Chin J Pharm Anal. 2006;26:1187-91.
Smith AA, Muthu AK, Manavalan R. Formulation development and evaluation of ondansetron hydrochloride sustained release matrix tablets. Int J Pharm Sci Res. 2009;1:48-54.
Liu K, Dai X, Zhong D, Chen X. Quantitative determination of ondansetron in human plasma by enantioselective liquid chromatography-tandem mass spectrometry. J Chromatogr B. 2008;864:129-36.
Miles DR, Mesfin M, Mody TD, Stiles M, Lee J, Fiene J, Denis B, Boswell GW. Validation and use of three complementary analytical methods (LC-FLS, LC-MS/MS and ICP-MS) to evaluate the pharmacokinetics, biodistribution and stability of motexafin gadolinium in plasma and tissues. Anal Bioanal Chem. 2006;385:345-56.
Sanwald P, David M, Dow J. Use of electrospray ionization liquid chromatography-mass spectrometry to study the role of CYP2D^ in the in vitro metabolism of 5-hydroxytryptamine receptor antagonists. J Chromatogr B. 1996;678:53-61.
Ammar HO, Mohamed MI, Tadros MI, Fouly AA. Transdermal delivery of Ondansetron hydrochloride via bilosomal systems: in vitro, ex vivo, and in vivo characterization studies. AAPS PharmSciTech. 2018;19:2276-87.
Srinivas J, Ravi Kumar A, Srinivas P, Raveendra Babu M, Ramyasree P. Novel stability indicating RP-HPLC method for the determination of Ondansetron impurities in Ondansetron Injection. Int J Curr Pharm Res. 2018;6.
Varvara A, Monciu CM, Armaa C, Popescu C. Application of selective bonded phase in the liquid chromatographic assay of ondansetron hydrochloride and its impurities. Farmacia 2009;57:570-81.
Simeone J, Hong P, McConville PR. Development and comparison of quantitative methods using orthogonal chromatographic techniques for the analysis of potential mutagenic impurities. 2017.
Milford PH, Ashland JS, Shrewsbury. United States Patent and Trademark Office. Alexandria, VA: Patent No.: US 10, 239, 866, B2. 2019.
Ferey L, Raimbault A, Rivals I, Gaudin K. UHPLC method for multiproduct pharmaceutical analysis by quality-by-design. J Pharm Biomed Anal. 2018;148:361-8.
Muchakayala SK, Pavithra K, Katari NK, Marisetti VM, Dongala T, Vegesna RVK. Development and validation of a RP-UPLC method for the determination of betamethasone dipropionate impurities in topical formulations using a multivariate central composite design. Anal Methods. 2021;13:3705-23.
Yenda P, Katari NK, Dongala T, Vyas G, Katakam LNR, Ettaboina SK. A simple isocratic LC method for quantification of trace-level inorganic degradation impurities (ferricyanide, ferrocyanide, nitrite, and nitrate) in sodium nitroprusside injection and robustness by quality using design approach. Biomed Chromatogr. 2022;36:e5269.
Kowtharapu LP, Katari NK, Sandoval CA, Muchakayala SK, Rekulapally VK. Green liquid chromatography method for the determination of related substances of mast cell stabilizer and histamine receptor antagonist in nasal spray formulation, QbD based approach for method robustness establishment. http://doi.org/10.2139/ssrn.3992391. Accessed February 1, 2022.
Kowtharapu LP, Katari NK, Surekha CH, Sandoval CA, Muchakayala SK, Konduru N. A QBD and green liquid chromatography technique for the determination of mast cell stabilizer and histamine receptor antagonist (Olopatadine HCl) in multiple formulations. Biomed Chromatogr. 2022;24:e5359.
Muchakayala SK, Katari NK, Dongala T, Marisetti VM, Vyas G, Vegesna RVK. Eco-friendly and green chromatographic method for the simultaneous determination of chlorocresol and betamethasone dipropionate in topical formulations using Box-Behnken design. J Iran Chem Soc. 2021.
Kurowska-Susdorf A, Zwierżdżyński M, Bevanda AM, Talić S, Ivanković A, Płotka-Wasylka J. Green analytical chemistry: social dimension and teaching. Trends Anal Chem. 2019;111:185-96.
Gałuszka A, Migaszewski ZM, Konieczka P, Namieśnik J. Analytical Eco-Scale for assessing the greenness of analytical procedures. Trends Anal Chem. 2012;37:61-72.
Płotka-Wasylka J. A new tool for the evaluation of the analytical procedure: Green Analytical Procedure Index. Talanta 2018;181:204-9.
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.
Konduru N, Gundla R, Katari NK, Paidikondala K, Reddy AS, Jagadabi V. Development and validation of a stability-indicating method for Ibrutinib: identification and separation of degradation products, known and genotoxic impurities using RP-HPLC/PDA and QDa mass detectors. Anal Chem Lett. 2020;10:113-36.
Konduru N, Kethe VB, Gundla R, Katari NK, Mallavarapu R. Determination of progesterone (steroid drug) in the semi-solid dosage form (vaginal gel) using a stability-indicating method by RP-HPLC/PDA detector. Biomed Chromatogr. 2021;15:e5246.
ICH Harmonized Tripartite Guideline. Validation of analytical procedures: text and methodology Q2 (R1). 2005.
USP 43 NF 38 General Chapters: <1225> Validation of compendial procedures. Rockville, MD: United States Pharmacopeial Convention; 2020.
Ph. Eur. general chapter- liquid chromatography (2.2.29). Strasbourg, France: Council of Europe; 2020.
USP 43 NF 38 General chapters: <621> chromatography. Rockville, MD: United States Pharmacopeial Convention; 2020.