Table 7.
Determination of ketoproten in pharmaceutical preparations
| Preparation | Proposed method |
Compendial methods |
|||
|---|---|---|---|---|---|
| Amount taken (μg/mL) | Amount found (μg/mL) | % recoverya | Amount taken (μg/mL) | % recoverya | |
| 1) ketofan capsules 50 mg ketoprofen/cap | 1.0 | 0.998 | 99.80 | 100.0 | 100.00 (22) |
| 2.0 | 2.01 | 100.50 | 200.0 | 100.20 | |
| 4.0 | 4.01 | 100.25 | 300.0 | 100.30 | |
| 6.0 | 6.00 | 100.00 | |||
| Mean ± S.D | 100.14 ± 0.30 | 100.20 ± 0.20 | |||
| t- test | 0.29 | (2.05)b | |||
| F- test | 2.25 | (19.16)b | |||
| 2) Ketofan tablets 25 mg ketoprofen/tab | 1.0 | 1.00 | 100.00 | 5.00 | 100.00 (23) |
| 2.0 | 2.01 | 100.50 | 10.00 | 99.90 | |
| 4.0 | 4.02 | 100.50 | 15.00 | 100.40 | |
| 6.0 | 5.99 | 99.83 | |||
| Mean ± S.D | 100.21 ± 0.34 | 100.10 ± 0.30 | |||
| t- test | 0.46 | (2.05)b | |||
| F- test | 1.28 | (19.16)b | |||
| 3) Dolokit ampoules 10 mg ketoprofen/amp | 1.0 | 1.01 | 101.00 | 10.0 | 100.00 (21) |
| 2.0 | 2.00 | 100.00 | 20.0 | 99.80 | |
| 4.0 | 4.03 | 100.75 | 30.0 | 100.80 | |
| 6.0 | 5.99 | 99.83 | |||
| Mean ± S.D | 100.39 ± 0.57 | 100.20 ± 0.53 | |||
| t- test | 0.47 | (2.05)b | |||
| F- test | 1.15 | (9.55)b | |||
| 4) Fastum gel 2.5% ketoprofen | 1.0 | 1.01 | 101.00 | 0.5 mg/mL | 100.00 (25) |
| 2.0 | 2.01 | 100.50 | 0.6 mg/mL | 100.30 | |
| 4.0 | 3.99 | 99.75 | 0.7 mg/mL | 99.90 | |
| 6.0 | 6.00 | 100.00 | |||
| Mean ± S.D | 100.31 ± 0.55 | 100.10 ± 0.20 | |||
| t- test | 0.60 | (2.05)b | |||
| F- test | 7.56 | (19.16)b | |||
| 5) Ketofan Suspension 12.5 mg ketoprofen/mL | 1.0 | 0.997 | 99.70 | 5.00 | 100.00 (23) |
| 2.0 | 2.01 | 100.50 | 10.00 | 99.80 | |
| 4.0 | 4.01 | 100.25 | 15.00 | 100.30 | |
| 6.0 | 6.00 | 100.00 | |||
| Means ± SD | 100.11 ± 0.34 | 100.00 ± 0.30 | |||
| t- test | 0.46 | (2.05)b | |||
| F- test | 1.28 | (19.16)b | |||
| 6) Alcofan suppositories 100 mg ketoprofen/suppository | 1.0 | 0.996 | 99.60 | 0.1 | 100.00 (22) |
| 2.0 | 2.01 | 100.50 | 0.2 | 99.90 | |
| 4.0 | 4.00 | 100.00 | 0.3 | 100.20 | |
| 6.0 | 5.99 | 99.83 | |||
| Mean ± S.D | 99.98 ± 0.38 | 100.00 ± 0.20 | |||
| t- test | 0.10 | (2.05)b | |||
| F- test | 3.61 | (19.16)b | |||
a
Each result is the average of three separate experiments;
b
The value of tabulated t and F, (at p=0.05) (36).
1), Ameryia-Alexandria-Egypt (Batch No.440544); 2), Ameryia-Alexandria-Egypt (Batch No.918743); 3), Sigma Pharmaceuticals-Egypt (Batch No.963340); 4), Minapharm-Egypt (Batch No.1750); 5), Amryia-Alexandria-Egypt (Batch No.958534); 6), Alexandria pharmaceuticals-Alexandria-Egypt (Batch No.4901020).