Raval VK Author

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A Validated RP-HPLC Method for the Simultaneous Determination of Six High-Boiling Residual Solvents in Drug Substances and Its Implementation in Apis

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 more»

DOI: 10.4172/2325-9604.1000173

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