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- Title
GC-FID ASSESEMENT OF RESIDUAL SOLVENTS PRESENT IN ADDITIVE-POLYSORBATE-80.
- Authors
Anumolu, P. D.; Rajesh, C. H.; Vamsi Krishna, L.; Gayathri, A. Radha; Mounika, G.; Sunitha, G.
- Abstract
Residual solvents in pharmaceuticals are defined here as organic volatile chemicals that are used or produced in the manufacture of drug substance or excipients or in the preparation of drug products. Polysorbate-80 is a non-ionic surfactant and emulsifier mostly used in foods and cosmetics. The organic solvents such as isopropyl alcohol, 1,4-dioxane, ethylene glycol and acetic acid are frequently used in manufacturing of polysorbate-80. Even after such manufacturing process of polysorbate-80, some solvents still remain in small quantities, which are potential toxic to humans. All these points signify that the need for some efforts for quantification of residual solvents present in polysorbate-80. The method utilized the Agilent 7700 with FID (DB-wax, 30m x 0.53mm, 1μ) capillary column, nitrogen as carrier gas with a flow rate of 1.8 mL/min. The critical experimental parameters such as oven temperature, zero air, make up flow, injection volume; split ratio and selection of diluent were studied and optimized. The retention time for residual solvents individually and in spiked standard solution was determined as 6.674, 9.477, 16.615 and 18.540 min for isopropyl alcohol, 1,4-dioxane, acetic acid and ethylene glycol respectively. The proposed method was also applied for the quantification of residual solvents present in marketed polysorbate-80. The developed method was statistically validated as per standard guidelines, and results obtained from validation proved that the proposed method was scientifically sound. The proposed method was fruitfully applied for the quantification of residual solvents (which are involved in the manufacturing process) present in polysorbate-80.
- Subjects
ORGANIC solvents; POLYSORBATE 80; ADDITIVES; FLAME ionization detectors; DRUG development; ACETIC acid; ETHYLENE glycol
- Publication
Rasayan Journal of Chemistry, 2016, Vol 9, Issue 4, p779
- ISSN
0974-1496
- Publication type
Article