Author(s): Vidhya K. Bhusari, Sunil R. Dhaneshwar

Email(s): vidhyabhusari@gmail.com

DOI: 10.52711/2231-5659.2021.00035   

Address: 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.
*Corresponding Author

Published In:   Volume - 11,      Issue - 3,     Year - 2021


ABSTRACT:
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

Cite(Electronic):
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


REFERENCES:
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.

Recomonded Articles:

Author(s): Rajashri R. Kulkarni, Dipti G. Phadtare, Ravindra B. Saudagar

DOI: 10.5958/2231-5659.2016.00019.9         Access: Open Access Read More

Author(s): Pradeep Sahu, Neha Pinkalwar, Ravindra Dhar Dubey, Shweta Paroha, Shilpi Chatterjee, Tanushree Chatterjee

DOI:         Access: Open Access Read More

Author(s): Sushil D. Patil, Prajkta Varpe, Sayali Chaure, Siddharth B. Bhalerao, Sanjay Kshirsagar

DOI: 10.5958/2231-5659.2017.00034.0         Access: Open Access Read More

Author(s): Namdeo G. Shinde, Bhaskar N. Bangar, Sunil M. Deshmukh, Suyog P. Sulake, Dipak P. Sherekar

DOI:         Access: Open Access Read More

Author(s): R. B. Saudagar, P. G. Thete

DOI: 10.5958/2231-5659.2018.00019.X         Access: Open Access Read More

Author(s): Kadam T.V. , Darekar A.B., Gondkar S.B., Saudagar R.B.

DOI: 10.5958/2231-5659.2015.00014.4         Access: Open Access Read More

Author(s): R Anusha Naik, Ajay Kumar D., M. Venkatesh

DOI: 10.5958/2231-5659.2018.00038.3         Access: Open Access Read More

Author(s): Bhalerao Atharva, Gade Vilas, Sonawane Sandeep, Chhajed Santosh, Kshirsagar Sanjay

DOI: 10.5958/2231-5659.2017.00025.X         Access: Open Access Read More

Author(s): Mawhoob N. Alkadasi, E.T. Putaiah, Kamal Olyoa, Arif Alameri , Gamal A. A-Ameri

DOI: 10.5958/2231-5659.2016.00034.5         Access: Open Access Read More

Author(s): M.A. Zeeshan Hamza, G. Kumaraswamy, Gandla Lalitha, R. Suthakaran

DOI:         Access: Open Access Read More

Author(s): Somsubhra Ghosh, Sowjanya Bomma, V. Laxmi Prasanna, P. Srivani, David Bhanji

DOI:         Access: Open Access Read More

Asian Journal of Research in Pharmaceutical Sciences (AJPSci) is an international, peer-reviewed journal, devoted to pharmaceutical sciences....... Read more >>>

RNI: Not Available                     
DOI: 10.52711/2231-5659 


Recent Articles




Tags