| Autor: |
A. V. S. S. Prasad, Hetero Drugs Ltd. , Plot No. B. , Apie, Balanagar, Hyderabad , India., V. V. S. S. R. Nanduri, K. R. Reddy |
| Rok vydání: |
2015 |
| Předmět: |
|
| Zdroj: |
INDIAN DRUGS. 52:24-27 |
| ISSN: |
0019-462X |
| Popis: |
Sensitive liquid chromatographic methods for the determination of two genotoxic impurities, namely hydrazine hydrate and 4-bromomethyl benzonitrile, in letrozole have been presented. Method-A is the pre-column derivative UFLC method for the determination of hydrazine hydrate with 4-methoxy benzaldehyde in letrozole. The chemistry involved in the derivatization is explained with suitable mechanism. Method-B offers the determination of 4-bromomethyl benzonitrile in letrozole. Both the methods were validated as per International Conference on Harmonization guidelines. Correlation coefficient values were found to be about 0.99. The % recoveries of the added impurities were found around the ranges of 94.2 to 94.6 for method-A and 92.5 to 100.5 for method-B. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
