Author(s): Ali Ismail, Mohammad Haroun, Youssef Alahmad

Email(s): ali.ismail@tishreen.edu.sy

DOI: 10.52711/0974-360X.2022.00541   

Address: Ali Ismail1, Mohammad Haroun2, Youssef Alahmad3
1Ph.D. Candidate, Department of Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, Tishreen University, Lattakia, Syria.
2Associated Professor, Department of Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, Tishreen University, Lattakia, Syria.
3Associated Professor, Department of Pharmaceutical Chemistry and Quality Control, Faculty of Pharmacy, Al Baath University, Homs, Syria.
*Corresponding Author

Published In:   Volume - 15,      Issue - 7,     Year - 2022


ABSTRACT:
As a part of impurity profiling, we aimed in this work to determine the content of organic volatile impurities (OVIs), commonly known as residual solvents (RSs), in different sources of dapagliflozin propandiol monohydrate as raw materials and marketed film-coated tablets. For that, a novel HS-GC-FID method has been developed and validated for determination of methanol, ethanol, ether, acetonitrile, dichloromethane, n-hexane, ethyl acetate, tetrahydrofuran and toluene. Dimethyl sulfoxide DMSO was used us diluent. The separation was achieved on Agilent DB-624 (30m, 0.530mm, 3.0µm) column and nitrogen as carrier gas with a total run time of 20 minutes. Solvents peaks indicate high resolution. Correlation factor R2 was estimated for each solvent and values ranged from 0.9990 to 0.9995. Estimation of limit of detection of these nine solvents showed that developed method was more sensitive than published method. The percentage recoveries calculated and the values ranged from 100.2% to 111.54%. The methods has been found to be simple, very sensitive, rugged, reliable and reproducible for the quantitation of these solvents in different sample of dapagliflozin raw materials and marketed tablets. Ethanol (class 3) and n-hexane (class 2) were detected in unacceptable level in some marketed samples.


Cite this article:
Ali Ismail, Mohammad Haroun, Youssef Alahmad. Estimation of Nine Organic Volatile Impurities in Bulk Dapagliflozin propandiol hydrate and Dosage forms from different sources using a new developed HS-GC-FID method. Research Journal of Pharmacy and Technology. 2022; 15(7):3226-2. doi: 10.52711/0974-360X.2022.00541

Cite(Electronic):
Ali Ismail, Mohammad Haroun, Youssef Alahmad. Estimation of Nine Organic Volatile Impurities in Bulk Dapagliflozin propandiol hydrate and Dosage forms from different sources using a new developed HS-GC-FID method. Research Journal of Pharmacy and Technology. 2022; 15(7):3226-2. doi: 10.52711/0974-360X.2022.00541   Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-7-63


REFERENCES:
1.    International Conference on Harmonization ICH of Technical Requirement for Registration of Pharmaceutical for Human Use. Impurities in New Drug Substances Q3A, 2006.
2.    The British Pharmacopoeia BP. Residual Solvents. 2013.
3.    Gorog S. Critical review of reports on impurity and degradation product profiling in the last decade. Trends in Analytical Chemistry. 2018;101: 2-16. doi.org/10.1016/j.trac.2017.09.012 .
4.    Ismail A, Alahmad Y. Determination of ethanol and n-hexane residues in bulk rosuvastatine and atorvastatin and their dosage forms using HS-GC-MS developed method. Research J. Pharm. and Tech. 2018; 11(11): 4829-4836.
5.    Grodowska K, Parczewski A. Analytical methods for residual solvents determination in pharmaceutical products. Acta Pol Pharm. 2010; 67(1):3-12.
6.    Grodowska K, Parczewski A. Organic solvents in the pharmaceutical industry. Acta Poloniae Pharmaceutica - Drug Research, 2010; 13-26.
7.    Dick F. D. Solvent neurotoxicity. Occup. Environ. Med. 2006; 63(3): 221-226.
8.    https://www.medicines.org.uk/emc/product/2865/smpc. emc- Forxiga 5 mg film coated tablets. 2019; Accessed on 27. February.
9.    Medhavi K. SGLT2 Inhibitors: A New generation of antidiabetic drugs. International Journal of Pharmaceutical Science and Nanotechnology. 2015; 2787-279.
10.    Akinici B. An update on dapagliflozin for the treatment of heart failure. Drugs Today (Barc), 2021; 57(2): 77-88.
11.    https://pubchem.ncbi.nlm.nih.gov/compound/Dapagliflozin-propanediolmonohydrate#section=InChI. 2020; Accessed on 15.10.  
12.    Kumar V. et. al. Determination of residual solvents in dapagliflozin amorphous by gas chromatography with static head space method. Scholars Research Library. 2016; 8(9):349-356.
13.    Patent: Novel solvate of dapagliflozin and preparation method thereof. Patent no: WO/2017/099496A1. 2017.
14.    International Conference on Harmonization ICH of Technical Requirement for Registration of Pharmaceutical for Human Use. Impurities: Guideline for Residual Solvents Q3C. 2016.
15.    International Conference on Harmonization ICH of Technical Requirement for Registration of Pharmaceutical for Human Use Guideline on Validation of Analytical Procedure: Text and Methodology Q2(R1). 2005.

Recomonded Articles:

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags


Not Available