Author(s): Rajesh Varma Bhupatiraju, Battula Sreenivasa Rao

Email(s): bhupathiraju.rajesh@gmail.com

DOI: 10.52711/0974-360X.2022.00868   

Address: Rajesh Varma Bhupatiraju*, Battula Sreenivasa Rao
Department of Chemistry, GITAM institute of Science, GITAM Deemed to be University, Visakhapatnam - 530045.
*Corresponding Author

Published In:   Volume - 15,      Issue - 11,     Year - 2022


ABSTRACT:
In this research we established a new GC-HS-FID (Gas Chromatography-Head Space-Flame Ionization Sensor) process for concurrent assessment of methanol (MTL), ethyl acetate (ETL), triethyl amine (TTL), and dichloromethane (DRM) in rivaroxaban (RVN) bulk medication. MTL, ETL, TTL and DRM were separated using DB 624 column (3.0 µm thickness film, 75 m length x 0.53 mm internal diameter). The proposed GC-HS-FID method was authenticated for MTL, ETL, TTL and DRM analysis in RVN sample following ICH guidelines. A good linearity was gained over a range of solvents concentration 750.32 to 4501.94 ppm (MTL), 1249.67 to 7498.04 ppm (ETL), 1246.2 to 7477.17 ppm (TTL) and 150.92 to 905.54 ppm (DRM). The precision, specificity, accuracy, robustness data were documented in the within the acceptable limits. The GC-HS-FID process method can be regularly exploited for the intent of MTL, ETL, TTL and DRM analysis in RVN samples.


Cite this article:
Rajesh Varma Bhupatiraju, Battula Sreenivasa Rao. Gas Chromatography-Head Space-Flame Ionization Sensor based assessment of four residuary solvents in rivaroxaban bulk medication. Research Journal of Pharmacy and Technology. 2022; 15(11):5158-3. doi: 10.52711/0974-360X.2022.00868

Cite(Electronic):
Rajesh Varma Bhupatiraju, Battula Sreenivasa Rao. Gas Chromatography-Head Space-Flame Ionization Sensor based assessment of four residuary solvents in rivaroxaban bulk medication. Research Journal of Pharmacy and Technology. 2022; 15(11):5158-3. doi: 10.52711/0974-360X.2022.00868   Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-11-53


REFERENCES:
1.    Carter NJ. Plosker GL. Rivaroxaban: a review of its use in the prevention of stroke and systemic embolism in patients with atrial fibrillation. Drugs 2013; 73(7): 715-739. doi.org/10.1007/s40265-013-0056-9
2.    Trujillo T. Dobesh PP. Clinical use of rivaroxaban: pharmacokinetic and pharmacodynamic rationale for dosing regimens in different indications. Drugs 2014; 74(14): 1587-1603. doi.org/10.1007/s40265-014-0278-5
3.    Jin G. Jie M. Feng Y. Wen-Ya X. Shuang S. Si-Lin W. Development and validation of a gas chromatography method for quality control of residual solvents in azilsartan bulk drugs. Journal of Chromatographic Science 2017; 55(4): 393–397. doi.org/10.1093/chromsci/bmw192
4.    International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Q3C (R5): Impurities: Guideline for Residual Solvents, Step 4; 2011.
5.    United States Pharmacopeia.  USP31/NF26 – General chapter < 467 > residual solvents; 2009.
6.    Ramisetti NR. Kuntamukkala R. Development and validation of a stability indicating LC-PDA-MS/MS method for separation, identification and characterization of process related and stress degradation products of rivaroxaban. RSC Advances 2014; 4(44): 23155–23167. doi.org/10.1039/c4ra00744a
7.    Rajan N. Basha KA. A Stability-Indicating ultra-performance liquid chromatographic method for estimation of related substances and degradants in rivaroxaban active pharmaceutical ingredient. Journal of Pharmacy Research 2014; 8(11): 1719-1725.
8.    Arous B. Al-Mardini MA Karabet F. Manal D. Al-Lahham F. Al-Askar A.  Development and validation of a liquid chromatography method for the analysis of rivaroxaban and determination of its production related impurities. Pharmaceutical Chemistry Journal 2018; 52: 483–490. doi.org/10.1007/s11094-018-1844-z
9.    Yashpalsinh NG. Srinivas R. Dipti S. Designing and quantification of impurity profile in an anticoagulant drug substance rivaroxaban. 7th international conference on research developments in Applied science, engineering and management, 2019, Mahratta chamber of commerce, industries and agriculture, Pune, India; 2019: 178-184.
10.    Babu JR. Suhasini J. Vidyadhara S. Residual solvents in bendamustine hydrochloride by headspace chromatography. Asian Journal of Pharmaceutical Analysis 2018; 8(1):07-12. doi.org/10.5958/2231-5675.2018.00002.9
11.    Ashwini RP. Prajkta MG. Bhavna JD. Manish SK. Review on chromatography principal types and it’s application. Research Journal of Pharmaceutical Dosage Forms and Technology, 2020;12(1):27-32. doi.org/10.5958/0975-4377.2020.00005.1
12.    Shoeb A. Amer A. Mahzia Ya. Validated HS-GC-FID method for determination of residual ethanol in solid dosage form. Research Journal of Pharmacy and Technology 2014; 7(2): 184-187.
13.    Ali I. Youssef A. Determination of ethanol and n-hexane residues in bulk rosuvastatin and atorvastatin and their dosage forms using HS-GC-MS developed method. Research Journal of Pharmacy and Technology 2018; 11(11): 4829-4836. doi.org/10.5958/0974-360X.2018.00878.8
14.    Sanapala SR. Vijayalakshmi A. Analytical method development and validation of glipizide to determine residual solvents by head space-gas chromatography. Research Journal of Pharmacy and Technology 2021; 14(5):2440-2444. doi.org/10.52711/0974-360X.2021.00429
15.    Raghad H. Fadi A. Saleh T. Yaser B. Determination thymol in thyme extract and its pharmaceutical forms by using gas chromatography method. Research Journal of Pharmacy and Technology 2020; 13(9): 4055-4060. doi.org/10.5958/0974-360X.2020.00717.9
16.    Rabie SF. Sayed RAA. Confirmatory method for determination of 11-Nor-Δ9 -Tetrahydrocannabinol-9-Carboxylic acid in urine samples using gas chromatography–mass spectrometry (GC/MS). Asian Journal of Research in Chemistry 2011; 4(3): 373-376.
17.    Cijo J. Mohd I. Sudhakar P. Priyankar G. Varshney KM. Shukla SK. Determination of clonazepam in chocolate using high performance liquid chromatography and further confirmation by gas chromatography- mass spectrometry. Asian Journal of Research in Chemistry 2011; 4(5): 761-765.
18.    Jose BE. Selvam PP. Identification of phytochemical constituents in the leaf extracts of azima tetracantha lam using gas chromatography-mass spectrometry (GC-MS) analysis and antioxidant activity. Asian Journal of Research in Chemistry 2018; 11(6): 857-862. doi.org/10.5958/0974-4150.2018.00150.5
19.    Ho TD. Yehl PM. Chetwyn NP. Wang J. Anderson JL. Zhong Q. Determination of trace level genotoxic impurities in small molecule drug substances using conventional headspace gas chromatography with contemporary ionic liquid diluents and electron capture detection. Journal of Chromatography A 2014; 1361: 217-228. doi.org/10.1016/j.chroma.2014.07.099
20.    Feng XZ, Han GC, Qin J, Yin SM, Chen Z. Determination of residual solvents in linezolid by static headspace GC. Journal of Chromatography Sciences 2016; 54(4): 487-491. doi.org/10.1093/chromsci/bmv175
21.    Poronsky CJ. Cutrone JQ. Chromatoprobe as a sample-sparing technique for residual solvent analysis of drug discovery candidates by gas chromatography. Journal of Pharmaceutical Analysis 2017; 7(4): 265-269. doi.org/10.1016/j.jpha.2017.03.009
22.    Nacham O. Ho TD. Anderson JL. Webster GK. Use of ionic liquids as headspace gas chromatography diluents for the analysis of residual solvents in pharmaceuticals. Journal of Pharmaceutical and Biomedical Analysis 2017; 145: 879-886. doi.org/10.1016/j.jpba.2017.05.033
23.    Sojitra C. Tehare A. Dholakia C. Padmaja S. Sameer A. Kumar KS. Development and validation of residual solvent determination by headspace gas chromatography in imatinib mesylate API. SN Applied Sciences 2019; 1: 233. doi.org/10.1007/s42452-019-0233-x
24.    Sugaya N. Takahashi M. Sakurai K. Tahara M. Kawakami T. Headspace GC/MS analysis of residual solvents in dietary supplements, cosmetics, and household products using ethyl lactate as a dissolution medium. Journal of AOAC International 2020; 103(2): 407-412. doi.org/10.5740/jaoacint.19-0260
25.    International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for Human Use, Q2 (R1): Validation of Analytical Procedures: Methodology, Step 4; 2005.
26.    Saudagar RB. Thete PG. Bioanalytical method validation: A concise review. Asian Journal of Research in Pharmaceutical Sciences 2018; 8(2): 107-114. doi.org/10.5958/2231-5659.2018.00019.X
27.    Raghava RN. Gowda KPK. Syed MA. Badami S. ICH guidelines with special emphasis on good clinical practice guidelines (GCP). Research Journal of Pharmacology and Pharmacodynamics 2010; 2(1): 27-32.


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