Author(s):
Immani Ramachandra Rao, Chava Lavanya, P. Punitha
Email(s):
analyticalchemphd@gmail.com
DOI:
10.52711/0974-360X.2023.00767 
Address:
Immani Ramachandra Rao, Chava Lavanya, P. Punitha*
Department of Chemistry, Annamalai Nagar, Annamalai University, Chidambaram, Tamil Nadu-608002, India.
*Corresponding Author
Published In:
Volume - 16,
Issue - 10,
Year - 2023
ABSTRACT:
ABSTRACT:
Relugolix API residual solvents (2-Propanol, n-Hexane, ethyl acetate, tetrahydrofuran, and toluene) were studied using a concise and low-cost GC-MS method. N-Methyl-2-pyrrolidone diluent is used (NMP). The DB-5 30m, 0.53 mm, 0.25 m film thickness column, 1.5 mL/min of helium as the carrier gas, 44.4 cm/sec of linear velocity, 200° C for the injector, 220° C for the mass detector ion source, 280° C for the interface, and a predetermined oven program were used to achieve the chromatographic separations. Within a 3.0 minute period, five residual solvents were eluted. The method was successfully validated by determining Specificity, Linearity, Accuracy, Limit of Detection, and Limit of Quantification.
Cite this article:
Immani Ramachandra Rao, Chava Lavanya, P. Punitha, A New Analytical Method for Determination and Quantification of Residual Solvents in Relugolix Api Bulk Drug by GC-MS Method, Research Journal of Pharmacy and Technology 2023; 16(10):4723-8. doi: 10.52711/0974-360X.2023.00767
Cite(Electronic):
Immani Ramachandra Rao, Chava Lavanya, P. Punitha, A New Analytical Method for Determination and Quantification of Residual Solvents in Relugolix Api Bulk Drug by GC-MS Method, Research Journal of Pharmacy and Technology 2023; 16(10):4723-8. doi: 10.52711/0974-360X.2023.00767 Available on: https://rjptonline.org/AbstractView.aspx?PID=2023-16-10-37
REFERENCES:
1. Feng X.Z, Han G.C, Qin J, Yin S.M, Chen Z. Determination of Residual Solvents in Linezolid by Static Headspace GC. Journal of Chromatographic Science. 2016; 54(4):487–91. doi: 10.1093/chromsci/bmv175
2. Joshi O, Parag G, Nitin N. Relugolix biological activity. International Journal of Pharma Research & Review, 2016;5(3):1-6
3. Anumolu P.D, Krishna V.L, Rajesh C.H, Alekya V, Priyanka B, Sunitha G. Gas Chromatographic Assessment of Residual Solvents Present in Excipient-Benzyl Alcohol. Journal of Chromatography Separation Techniques. 2016; 7:2-4. doi:10.4172/2157-7064.1000321
4. G. Katarzyna G, Andrzej P. Analytical methods for residual solvents determination in pharmaceutical products. Acta Poloniae Pharmaceutica and Drug Research. 2010;67(1): 13-26
5. Anil Kumar V , Aravind G, Srikanth I , Srinivasa Rao A , Dharma Raju C.H. Novel analytical method development and validation for the determination of residual solvents in amlodipine besylate by gas chromatography. Der Pharma Chemica. 2012; 4(6): 2228-38
6. P. P. Ana, A. Jelena, S. G. joshe, B. Katerina , P. Rumenka , D. Aneta. Optimization of HS-GC–FID–MS Method for Residual Solvent Profiling in Active Pharmaceutical Ingredients Using DoE. Journal of Chromatographic Science. 2016: 54 (2): 103-111. https://doi.org/10.1093/chromsci/bmv123
7. Olaf Panknin, Andrea Wagenfeld, Wilhelm Bone, Eckhard Bender, Katrin Nowak-Reppel, Amaury E. Fernández-Montalván, Reinhard Nubbemeyer, Discovery and Characterization of BAY 1214784, an Orally Available Spiroindoline Derivative Acting as a Potent and Selective Antagonist of the Human Gonadotropin-Releasing Hormone Receptor as Proven in a First-In-Human Study in Postmenopausal Women. J. Medicinal. Chemistry. 2020; 63: 11854−881. https://doi.org/10.1021/acs.jmedchem.0c01076
8. Kalyankar T, Wadher S. J., Anitha K , Sominath D. Improvement of aqueous solubility and In-vitro drug release rate of Telmisartan using hydrophilic base by various dispersion techniques. International Journal of PharmTech Research. 2016; 9(1):28-34
9. ICH Q3C (R5) (2005) ICH Harmonized tripartite guideline, Impurities in New Drug Products, International Conference on Harmonization ICH, Geneva.
10. Ramesh Babu J, Suhasini J, Vidyadhara S. Residual Solvents in Bendamustine Hydrochloride by Headspace Chromatography. Asian J. Pharm. Ana. 2018; 8(1): 07-12. 10.5958/2231-5675.2018.00002.9
11. Sandip A Telavane, Seema Kothari , Manohar V. Lokhande, Method of Validation for Residual Solvents in Bisoprolol Fumarate by GC Technique. Asian Journal of Pharmaceutical Research. 2021; 11(3):147-155. DOI: 10.52711/2231-5691.2021.00028.
12. Ali Ismail1, Youssef Alahmad. Determination of ethanol and n-hexane residues in bulk rosuvastatin and atorvastatin and their dosage forms using HS-GC-MS developed method. Research J. Pharm. and Tech. 2018;11(11):4829-4836. 10.5958/0974-360X.2018.00878.8
13. Sanapala Srinivasa Rao, Vijayalakshm A. Analytical Method Development and Validation of Glipizide to Determine Residual solvents by head Space-Gas Chromatography. Research J. Pharm. and Tech. 2021; 14(5): 2440-44. 10.5958/0974-360X.2021.00244.4
14. C. Hazarathaiah Yadav, A. Malli Babu. Development and Validation of Head-space Gas Chromatographic Method in Tandem with Flame ionized detection for the determination of Residual solvents in Simeprevir API Synthesis. Research J. Pharm. and Tech. 2021; 14(10): 5175-81. 10.52711/0974-360X.2021.00900
15. Tentu Nageswara Rao, Muralidhar Reddy Avuthu, B. Venkata Reddy, SNVS Murthy. Forced degradation study of Terbinafine HCl by HPLC with PDA detector. Asian J. Research Chem. 2016; 9(11): 561-565. doi: 10.5958/0974-4150.2016.00076.6.
16. Tentu Nageswara Rao, Imad Hussain, Y. Prashanthi, T. B. Patrudu. Forced Degradation Study for Tolterodine by HPLC with PDA Detection. Asian J. Pharm. Ana. 2019; 9(2):77-81. doi: 10.5958/2231-5675.2019.00015.2
17. ICH Q2 (R1) (2005) ICH Harmonized tripartite guideline for validation of analytical procedure.