Table 2 System suitability test of Fosamprenavir and its impurities
Parameter (n = 5) | Amino | Propyl | Isomer | Fosamprenavir | Nitro | Amprenavir | Acceptance criteria |
|---|---|---|---|---|---|---|---|
Retention Time (RT) | 2.389 | 4.384 | 4.749 | 5.372 | 8.165 | 8.603 | ± 10% |
USP plates | 4959 | 9751 | 13,490 | 21,124 | 58,525 | 57,180 | > 2000 |
USP tailing | 1.15 | 1.08 | 1.10 | 1.11 | 1.15 | 1.10 | ≤ 2 |
Resolution between Isomer and Fosamprenavir | 3.42 | < 2 | |||||