Vidhya K. Bhusari, Sunil R. Dhaneshwar
Vidhya K. Bhusari1*, Sunil R. Dhaneshwar2
1Department of Pharmaceutical Chemistry, Sinhgad Technical Education Society’s, Smt. Kashibai Navale College of Pharmacy, Kondhwa, Pune, Maharashtra, India.
2Pro Vice Chancellor, Amity University U.P. Lucknow Campus, Lucknow, India.
Volume - 11,
Issue - 3,
Year - 2021
Objective: A simple, sensitive, selective, precise repeatable and stability-indicating high-performance thin layer chromatographic method was developed and validated for Eszopiclone in bulk drug and in formulation. Method: Silica gel 60 F-254, TLC precoated aluminium plates was used as the stationary phase for analyzing Eszopiclone and its degradation products, using mobile phase consisting toluene: ethyl acetate: methanol (6: 4: 2 v/v/v). Result: This mobile phase gave compact spots for Eszopiclone with Rf value of 0.52 ± 0.02. Eszopiclone was exposed to hydrolysis, oxidation, neutral and photolytic conditions for conducting stress degradation study. The peak of Eszopiclone and the degradation product was well resolved from each other with a significantly different Rf value. Densitometric estimation of Eszopiclone was performed at 304nm. A good linear plot was obtained in the concentration range of 150-300ng/spot. The method was validated for precision, accuracy (recovery) and robustness study. The limit of detection (LOD) and limit of quantitation (LOQ) was found to be 130ng/spot and 150ng/spot, respectively. Conclusion: The developed HPTLC method can separate Eszopiclone from its degradation products, hence stability studies can be performed using this method.
Cite this article:
Vidhya K. Bhusari, Sunil R. Dhaneshwar. Development and Validation of a Stability-Indicating HPTLC Method for the Estimation of Eszopiclone in Pharmaceutical Dosage Forms. Asian Journal of Research in Pharmaceutical Sciences. 2021; 11(3):219-3. doi: 10.52711/2231-5659.2021.00035
Vidhya K. Bhusari, Sunil R. Dhaneshwar. Development and Validation of a Stability-Indicating HPTLC Method for the Estimation of Eszopiclone in Pharmaceutical Dosage Forms. Asian Journal of Research in Pharmaceutical Sciences. 2021; 11(3):219-3. doi: 10.52711/2231-5659.2021.00035 Available on: https://ajpsonline.com/AbstractView.aspx?PID=2021-11-3-7
1. International Conference on Harmonization ICH, Q1A (R2) Stability Testing of New Drug Substances and Products, IFPMA, Geneva, Switzerland.
2. International Conference on Harmonization ICH, Q1B Photostability Testing of New Active Substances and Medicinal Products.
3. International Conference on Harmonization ICH, Q2(R1) Validation of Analytical Procedures: Text and Methodology.
4. USP 43 General Information 〈1225〉 Validation of Compendial Procedures
5. https://www.drugbank.ca/drugs/DB00402 (Accessed May 28, 2020).
6. Anandakumar K., Kumaraswamy G, Ayyappan T, Sankar ASK., Nagavalli, D. Estimation of Eszopiclone in Bulk and in Formulation by Simple UV and Difference Spectroscopic Methods. Research Journal of Pharmacy and Technology. 2010; 3(1): 202-205.
7. Meng M, Rohde L, Capka, 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): 973-982.
8. Anandakuma K., Kumaraswamy G, Ayyappan T, Sankar ASK, Nagavalli D. Validated RP-HPLC method for the estimation of Eszopiclone in bulk and tablet dosage form. Asian Journal of Research in Chemistry. 2010; 3(1): 63-66.
9. Dhaneshwar SR, Bhusari VK. Development of a validated stability-indicating HPLC assay method for Eszopiclone. International Journal of ChemTech Research. 2011; 3(2): 680-689.
10. Kumar NR, Rao NG, Naidu PY. Stability Indicating RP-LC Method for Determination of Eszopiclone in Bulk and Pharmaceutical Dosage Forms. Asian Journal of Research in Chemistry. 2010; 3(2): 374-379.
11. 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): 7590-7595.