Affiliation:
1. Department of Chemistry, Annamalai Nagar, Annamalai University, Chidambaram, Tamil Nadu-608002, India.
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.
Subject
Pharmacology (medical),Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Reference17 articles.
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