Author(s):
Komali Sivaprasad, Vardhani Devi Duggirala Parvatha Venkata, Kapavarapu Maruthi Venkata Narayanarao, Pulipaka Shyamala
Email(s):
sivakomali1811@gmail.com
DOI:
10.52711/0974-360X.2022.00848 
Address:
Komali Sivaprasad1*, Vardhani Devi Duggirala Parvatha Venkata1, Kapavarapu Maruthi Venkata Narayanarao1, Pulipaka Shyamala2
1GVK Biosciences Pvt Ltd, Hyderabad, Telangana, India – 500076.
2Physical Chemistry Department, Andhra University, Visakhapatnam, Andhra Pradesh, India – 530003.
*Corresponding Author
Published In:
Volume - 15,
Issue - 11,
Year - 2022
ABSTRACT:
The intent of this research paper was to describe a “headspace gas chromatography (HGC)” procedure development and its completely validation for the analysis of residuals of methanol (MTL), isopropyl alcohol (IPL), t-butanol (TBL), toluene (TLE) and dimethylformamide (DFL) simultaneously in Etoricoxib (EIB). The experimentations are done on HGC system fitting with flame ionization type detector employing DB-624 silica fused capillary column (stationary phase) and nitrogen gas (mobile phase). The injector port and detector port temperatures were kept at 200 oC and 260 oC, respectively. N-methyl pyrrolidone was diluent. The MTL, IPL, TBL, TLE, and DFL detection (LOD) and quantitation (LOQ) values were much smaller than their ICH specification level concentrations. The linear corelation evaluated through range of LOQ to 150% of ICH specification level concentrations for MTL, IPL, TBL, TLE, and DFL of ICH. The regression coefficients for MTL, IPL, TBL, TLE, and DFL were =0.9950, and the diagrams of theoretic residuals concentration versus gotten peak response are linear. The HGC procedure proposed was represented by great accuracy, precision, ruggedness and specificity. For a minimum of 48 hr, the EIB sample with MTL, IPL, TBL, TLE and DFL is stable while managed to keep at ambient temperature. The current developed and completely validated HGC procedure can run effectively for EIB residual solvents (MTL, IPL, TBL, TLE and DFL) assessing in active pharma ingredient production.
Cite this article:
Komali Sivaprasad, Vardhani Devi Duggirala Parvatha Venkata, Kapavarapu Maruthi Venkata Narayanarao, Pulipaka Shyamala. Residual Solvents by GC-HS Procedure for Etoricoxib: Method Development and Validation Report. Research Journal of Pharmacy and Technology. 2022; 15(11):5043-9. doi: 10.52711/0974-360X.2022.00848
Cite(Electronic):
Komali Sivaprasad, Vardhani Devi Duggirala Parvatha Venkata, Kapavarapu Maruthi Venkata Narayanarao, Pulipaka Shyamala. Residual Solvents by GC-HS Procedure for Etoricoxib: Method Development and Validation Report. Research Journal of Pharmacy and Technology. 2022; 15(11):5043-9. doi: 10.52711/0974-360X.2022.00848 Available on: https://rjptonline.org/AbstractView.aspx?PID=2022-15-11-33
REFERENCES:
1. Cui Y. Chung TS. Pharmaceutical concentration using organic solvent forward osmosis for solvent recovery. Natural Communications. 2018; 9(1):1426. doi.org/10.1038/s41467-018-03612-2
2. Rantanen J. Khinast J. The Future of Pharmaceutical Manufacturing Sciences. Journal of Pharmaceutical Sciences. 2015; 104(11):3612-8. doi.org/10.1002/jps.24594
3. Dixit K. Athawale RB. Singh S. Quality control of residual solvent content in polymeric microparticles. Journal of Microencapsulation. 2015; 32(2):107-22. doi.org/10.3109/02652048.2014.995730
4. Joshi D. Adhikari N. An Overview on Common Organic Solvents and Their Toxicity. Journal of Pharmaceutical Research International. 2019; 28(3):01-18. doi.org/10.9734/jpri/2019/v28i330203
5. Modla G. Lang P. Removal and recovery of organic solvents from aqueous waste mixtures by extractive and pressure swing distillation. Industrial & Engineering Chemistry Research. 2012; 51(35):11473–81. doi.org/10.1021/ie300331d
6. Graham L. Maximizing Solvent Removal Efficiency. Pharmamanufacturing.com. Accessed on April 2021. Available at: https://www.pharmamanufacturing.com/articles/2014/maximizing-solvent-removal-efficiency/
7. Removal of Residual Solvent after Manufacturing. adroitscience.com. Accessed on April 2021. Available at: https://www.pharmamanufacturing.com/articles/2014/maximizing-solvent-removal-efficiency/
8. Shi S. Klotz U. Clinical use and pharmacological properties of selective COX-2 inhibitors. European Journal of Clinical Pharmacology. 2008; 64(3):233-52. doi.org/10.1007/s00228-007-0400-7
9. Bickham K. Kivitz AJ. Mehta A. Frontera N. Shah S. Stryszak P. Popmihajlov Z. Peloso PM. Evaluation of two doses of etoricoxib, a COX-2 selective non-steroidal anti-inflammatory drug (NSAID), in the treatment of Rheumatoid Arthritis in a double-blind, randomized controlled trial. BMC Musculoskeletal Disorder. 2016; 17:331. doi.org/10.1186/s12891-016-1170-0
10. Kwiatkowska B. Majdan M. Mastalerz-Migas A. Niewada M. Skrzydło-Radomańska B. Mamcarz A. Status of etoricoxib in the treatment of rheumatic diseases. Expert panel opinion. Reumatologia. 2017; 55(6):290-97. doi.org/10.5114/reum.2017.72626.
11. Huang WN. Tso TK. Etoricoxib improves osteoarthritis pain relief, joint function, and quality of life in the extreme elderly. Bosnian Journal of Basic Medical Sciences. 2018; 18(1):87-94. doi.org/10.17305/bjbms.2017.2214
12. Croom KF. Siddiqui MA. Etoricoxib: a review of its use in the symptomatic treatment of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and acute gouty arthritis. Drugs. 2009; 69(11):1513-32. doi.org/10.2165/00003495-200969110-00008
13. ICH harmonised guideline, impurities: guideline for residual solvents Q3C(R6), International council for harmonisation of technical requirements for pharmaceuticals for human use; 2016.
14. Zhang X. Liu W. Lu Y. Lü Y. Recent advances in the application of headspace gas chromatography-mass spectrometry. Se Pu. 2018; 36(10):962-71. doi.org/10.3724/SP.J.1123.2018.05013
15. 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
16. 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):184-7.
17. 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
18. 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): 4829-36. doi.org/10.5958/0974-360X.2018.00878.8
19. 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):4055-60. doi.org/10.5958/0974-360X.2020.00717.9
20. 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):761-5.
21. 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):373-6.
22. 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):857-62. doi.org/10.5958/0974-4150.2018.00150.5
23. 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):2440-4. doi.org/10.52711/0974-360X.2021.00429
24. Saber AN. Zhang H. Yang M. Optimization and validation of headspace solid-phase microextraction method coupled with gas chromatography-triple quadrupole tandem mass spectrometry for simultaneous determination of volatile and semi-volatile organic compounds in coking wastewater treatment plant. Environmental Monitoring and Assessment. 2019; 191(7):411. doi.org/10.1007/s10661-019-7554-5
25. Ozaki A. Kishi E. Ooshima T. Kakutani N. Abe Y. Mutsuga M. Yamano T. Headspace GC/MS analysis of residual solvents in laminated films used for food packaging. Shokuhin Eiseigaku Zasshi. 2019; 60(4):73-81. doi.org/10.3358/shokueishi.60.73
26. Hwang JB. Lee S. Yeum J. Kim M. Choi JC. Park SJ. Kim J. HS-GC/MS method development and exposure assessment of volatile organic compounds from food packaging into food simulants. Food Additives & contaminants / A: Chemistry, Analysis, Control, Exposure & Risk Assessment. 2019; 36(10):1574-83. doi.org/10.1080/19440049.2019.1642520
27. Cheng C. Liu S. Mueller BJ. Yan Z. A generic static headspace gas chromatography method for determination of residual solvents in drug substance. Journal of Chromatography A. 2010; 1217(41):6413-21. doi.org/10.1016/j.chroma.2010.08.016
28. Al-Taher F. Nemzer B. Determination and quantitation of residual solvents in natural food ingredients using a static headspace gas chromatography with flame ionization detection and mass spectrometric detection method. Journal of Food Protection. 2018; 81(10):1573-81. doi.org/10.4315/0362-028X.JFP-18-142
29. ICH Harmonised tripartite guideline. Validation of analytical procedures: text and methodology Q2(R1). In International Conference on Harmonization of Technical Requirements for registration of pharmaceuticals for human use, International Conference on Harmonisation; 2005.
30. 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.
31. Saudagar RB. Thete PG. Bioanalytical method validation: A concise review. Asian Journal of Research in Pharmaceutical Sciences. 2018; 8(2):107-14. doi.org/10.5958/2231-5659.2018.00019.X