New Validated Stability-Indicating RP-HPLC Method for The Determination of Docetaxel and Its Related Substances
Autor: | Mukthinuthalapati Mathrusri Annapurna, S. Hemchand, R. Ravi Chandra Babu |
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Rok vydání: | 2019 |
Předmět: | |
Zdroj: | Research Journal of Pharmacy and Technology. 12:4165 |
ISSN: | 0974-360X 0974-3618 |
Popis: | Docetaxel is used for the treatment of castration resistant prostate cancer. Docetaxel is a semi synthetic chemo therapeutic agent extracted from the leaves of Taxus baccata. Two process related substances and four impurities were separated and quantified using Sunfire C18 column (250 x 4.6 mm, 5µm particle size) on gradient mode (40 ± 5°C). A mixture of acetonitrile: 0.01 % Acetic acid was used as mobile phase and a mixture of acetonitrile: methanol (1:1, v/v) was used as diluent and the compounds were monitored at 230 nm. Forced degradation studies were performed and the method was validated as per ICH guidelines. |
Databáze: | OpenAIRE |
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