El-Yazbi, A., Ahmmed, H. (2024). Green inexpensive capillary electrophoretic method for the determination of Eszopiclone in pharmaceutical preparations. test, 1(1), 1-10. doi: 10.21608/japs.2024.252648.1006
Amira El-Yazbi; Hytham M Ahmmed. "Green inexpensive capillary electrophoretic method for the determination of Eszopiclone in pharmaceutical preparations". test, 1, 1, 2024, 1-10. doi: 10.21608/japs.2024.252648.1006
El-Yazbi, A., Ahmmed, H. (2024). 'Green inexpensive capillary electrophoretic method for the determination of Eszopiclone in pharmaceutical preparations', test, 1(1), pp. 1-10. doi: 10.21608/japs.2024.252648.1006
El-Yazbi, A., Ahmmed, H. Green inexpensive capillary electrophoretic method for the determination of Eszopiclone in pharmaceutical preparations. test, 2024; 1(1): 1-10. doi: 10.21608/japs.2024.252648.1006

Green inexpensive capillary electrophoretic method for the determination of Eszopiclone in pharmaceutical preparations

Journal of Advanced Pharmaceutical Sciences
Volume 1, Issue 1, January 2024, Pages 1-10    PDF (876.84 K)
Document Type: Original Article
DOI: 10.21608/japs.2024.252648.1006
Authors
Amira El-Yazbi* 1; Hytham M Ahmmed2
1Analytical Chemistry Department, Faculty of Pharmacy Alexandria University
2Pharmaceutical Analysis Department, Faculty of Pharmacy, Menoufia University, Shebin El-Kom, Egypt
Abstract
Background: Eszopiclone (EZO) is a newly FDA-approved drug for the treatment of sleeping disorders (insomnia). It is a short-acting non-benzodiazepine sedative hypnotic. Objectives: The development and validation of an environment-friendly, rapid, simple, and inexpensive capillary electrophoresis (CE) for the routine determination of eszopiclone (EZO) in commercial dosage forms. Method: The method was performed using 75 μm × 82 cm fused-silica capillary (70 cm effective length). Detection was performed at 300 nm with a background electrolyte of 10 mM phosphate buffer pH 7.50 with 30kV applied voltage for 10 s at 25◦C temperature. Well-shaped peaks of eszopiclone were obtained (at tM = 4.41 ± 0.18 min). Validation was performed in terms of precision, accuracy, specificity and robustness in accordance with ICH guidelines. Results: Concentrations within the range 10–300 µg mL-1 were found to be linear with high correlation coefficient, r = 0.9998. Detection and quantitation limits were 1.36 and 4.66 µg mL-1, respectively. Our proposed method was successfully applied  for eszopiclone analysis in its pharmaceutical dosage form. An analysis of variance test confirmed that there were no significant differences between the proposed method and the two reported reference methods.

Highlights
  • A capillary electrophoretic method is developed for eszopiclone analysis.
  • The developed method is highly sensitive, rapid, simple, economical, and eco-friendly.
  • It is applied for the determination of eszopiclone in commercial formulations.
Keywords
Eszopiclone; capillary electrophoresis; tablets; validation; quality control
Supplementary Files
References
  1. Patil P, Kothekar M. Development of safer molecules through chirality. 2006.
  2. El-Yazbi AF, Eman I, Youssef RM. Hantzsch pre-column derivatization for simultaneous determination of alendronate sodium and its pharmacopoeial related impurity: Comparative study with synchronous fluorometry using fluorescamine. journal of food and drug analysis. 2019;27(1):208-20.
  3. Ibrahim F, El-Yazbi A, Wagih M, Barary M. Sensitive inexpensive spectrophotometric and spectrofluorimetric analysis of ezogabine, levetiracetam and topiramate in tablet formulations using Hantzsch condensation reaction. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2017;184:47-60.
  4. Ibrahim FA, El-Yazbi AF, Wagih MM, Barary MA. Chromatographic determination of zonisamide, topiramate and sulpiride in plasma by a fluorescent ‘turn-on’chemosensor. Bioanalysis. 2017;9(14):1049-64.
  5. El-Yazbi AF, El-Hawiet A. Novel Chromatographic Methods for Simultaneous Quantification of Fish and Wheat Germ Oils Mixture in Pharmaceutical Dosage Forms. Journal of chromatographic science. 2017;55(5):497-507.
  6. Ibrahim FA, El-Yazbi AF, Barary MA, Wagih MM. Sensitive inexpensive HPLC determination of four antiepileptic drugs in human plasma: application to PK studies. Bioanalysis. 2016;8(21):2219-34.
  7. El-Yazbi A, Wagih M, Ibrahim F, Barary M. Spectrofluorimetric determination of topiramate and levetiracetam as single components in tablet formulations and in human plasma and simultaneous fourth derivative synchronous fluorescence determination of their co-adminstered mixture in human plasma. Journal of fluorescence. 2016;26:1225-38.
  8. El-Kimary EI, Allam AN, Khafagy E-S, Hegazy WA. Analytical Methodologies for the Estimation of Oxazolidinone Antibiotics as Key Members of anti-MRSA Arsenal: A Decade in Review. Critical Reviews in Analytical Chemistry. 2023:1-30.
  9. Chennaiah M, Veeraiah T, Venkateshwarlu G. Spectrophotometric determination of eszopiclone in pure and pharmaceutical forms. Journal of the Chilean Chemical Society. 2012;57(4):1460-3.
  10. Pandya J, Dubey A, Prabhu P. Development and validation of UV spectrophotometric and RP HPLC method for the estimation of eszopiclone bulk and tablets. International Journal of Advances in Pharmaceutical Analysis. 2013;3(1):11-9.
  11. Ravi D, Rao JS, RajaLakshmi D, Nakka J. Development and validation of an RP-HPLC Method for the determination of the Eszopiclone in tablet dosage forms. Inter j of res in pharm and Chem. 2014;4:119-30.sad
  12. Meng M, Rohde L, Čápka V, Carter SJ, Bennett PK. Fast chiral chromatographic method development and validation for the quantitation of eszopiclone in human plasma using LC/MS/MS. Journal of pharmaceutical and biomedical analysis. 2010;53(4):973-82.
  13. Dhaneshwar SR, Bhusari V. Development of Valedated Stability-Indicating HPLC assay method for Eszopiclone. Inter J Chem Tech Res. 2011;3(2):680.
  14. Shaikh K, Patil A, Gite S. Stability-Indicating LC–UV Method for the Determination of Eszopiclone and Degradation Impurities in Tablet Dosage Form. Journal of chromatographic science. 2014;52(4):293-7.
  15. Kumar RN, Rao GN, Naidu P. Stability Indicating RP-LC Method for Determination of Eszopiclone in Bulk and Pharmaceutical Dosage Forms. Asian journal of research in chemistry. 2010;3(2):374-9.
  16. Sharma N, Rao SS, Kumar NDA, Reddy AM. A novel validated ultra-performance liquid chromatography Method for separation of eszopiclone impurities and its degradants in drug products. Journal of AOAC International. 2013;96(5):981-6.
  17. Salama N, Zaazaa H, Abd El Halim L, Salem M, Abd El Fattah L. Thin-layer chromatographic enantioseparation of ofloxacin and zopiclone using hydroxy-propyl-beta-cyclodextrin as chiral selector and thermodynamic studies of complexation. JPC-Journal of Planar Chromatography-Modern TLC. 2014;27(3):166-73.
  18. Paw B, Misztal G. Chromatographic analysis (TLC) of zopiclone and benzodiazepines. JPC. 2000;13(3):195-8.
  19. El-Yazbi AF, Youssef RM. An eco-friendly HPTLC method for assay of eszopiclone in pharmaceutical preparation: investigation of its water-induced degradation kinetics. Analytical Methods. 2015;7(18):7590-5.
  20. Ha PTT, Hoogmartens J, Van Schepdael A. Recent advances in pharmaceutical applications of chiral capillary electrophoresis. Journal of pharmaceutical and biomedical analysis. 2006;41(1):1-11.
  21. de Carvalho RC, Netto ADP, de Carvalho Marques FF. Simultaneous determination of strontium ranelate and aspartame in pharmaceutical formulation for the treatment of postmenopausal osteoporosis by capillary zone electrophoresis. Microchemical Journal. 2014;117:214-9.
  22. Ahmed HM, Ebeid WB. The use of laser-induced fluorescence or ultraviolet detectors for sensitive and selective analysis of tobramycin or erythropoietin in complex samples. Spectrochimica Acta Part A: Molecular and Biomolecular Spectroscopy. 2015;143:12-9.
  23. Gumustas M, Alshana U, Ertas N, Goger NG, Ozkan SA, Uslu B. Determination of antazoline and tetrahydrozoline in ophthalmic solutions by capillary electrophoresis and stability-indicating HPLC methods. Journal of Pharmaceutical and Biomedical Analysis. 2016;124:390-8.
  24. ICH, editor Q2 (R1): Validation of analytical procedures: text and methodology. International Conference on Harmonization, Geneva; 2005.
  25. Miller J, Miller JC. Statistics and chemometrics for analytical chemistry: Pearson education; 2018.
  26. Armitage P, Berry G, Matthews JNS. Statistical methods in medical research: John Wiley & Sons; 2008.
  27. Płotka-Wasylka J. A new tool for the evaluation of the analytical procedure: Green Analytical Procedure Index. Talanta. 2018;181:204-9.
  28. Gałuszka A, Migaszewski ZM, Konieczka P, Namieśnik J. Analytical Eco-Scale for assessing the greenness of analytical procedures. TrAC Trends in Analytical Chemistry. 2012;37:61-72.
Statistics
Article View: 218
PDF Download: 256