Deshpande NM Author
Subjects of specialization
Affiliation
Human brucellosis;
Department of Electronics and Telecommunication, Symbiosis Institute of Technology, Symbiosis International (Deemed University), Pune, Maharashtra, India
Department of Electronics and Telecommunication, Symbiosis Institute of Technology, Symbiosis International (Deemed University), Pune, Maharashtra, India
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Author(s): Gangrade MG, Deshpande NM, Gharat HP*, More SD, Shinde SS, Raval VK, Sapre JV and Alexander RT
A new method using high-performance liquid chromatography coupled with ultra violet detection was developed and validated for the simultaneous quantification of six high-boiling residual solvents-Acetic acid, N,N-dimethylformamide, Dimethyl sulfoxide, N, N-dimethylacetamide, N-methyl-2-pyrrolidone and Benzyl alcohol in drug substances. This paper describes the development and validation of a simple and efficient RP-HPLC method for the determination of these high boiling residual solvents. Quantitation limits for Acetic Acid is 1000ppm (1000 μg/g of API), for Dimethylsulfoxide is 400 ppm (400 μg/g of API), for N, N dimethylformamide is 70 ppm (70 μg/g of API), for Dimethylacetamide is 80 ppm (80 μg/g of API), for N-methyl-2-pyrrolidone is 40 ppm (... view moreĀ»