"Determination of Rasagiline Mesylate in dosage form and in human plasma and its application in bioequivalence study"
Hassan Mohamed Hassan Soliman;
Abstract
• Accuracy and precision: Recovery experiments were employed to determine the accuracy of the proposed analytical method at three different concentrations were prepared in triplicate (25, 75, and 125 %) of 2 μg/ml to be analyzed.
The same three concentrations were compared to standard solution. The values of recovery for injected samples showed high recovery values (100.39, 99.47, and 99.85 %) respectively.
• Robustness: Robustness of the method was studied at different pH and flow rate
and it was observed that there were no changes in the chromatograms.
The method applied to compare the dissolution results.
Difference and Similarity factors used to compare dissolution profiles. Difference factor (f1=6), and for similarity factor (f2 = 60). The results showed similar behavior between the test and reference product.
o For in the in vivo determination
A sensitive LC/MS-MS method developed to determine Rasagiline in human plasma.
The LC/MS-MS method validated as per FDA guidelines.
Validation items:
o Selectivity:
Selectivity of the method was ensured against endogenous compounds from six different plasma sources and against OTC drugs (Acetaminophens, Acetyl Salicylic Acid,
The same three concentrations were compared to standard solution. The values of recovery for injected samples showed high recovery values (100.39, 99.47, and 99.85 %) respectively.
• Robustness: Robustness of the method was studied at different pH and flow rate
and it was observed that there were no changes in the chromatograms.
The method applied to compare the dissolution results.
Difference and Similarity factors used to compare dissolution profiles. Difference factor (f1=6), and for similarity factor (f2 = 60). The results showed similar behavior between the test and reference product.
o For in the in vivo determination
A sensitive LC/MS-MS method developed to determine Rasagiline in human plasma.
The LC/MS-MS method validated as per FDA guidelines.
Validation items:
o Selectivity:
Selectivity of the method was ensured against endogenous compounds from six different plasma sources and against OTC drugs (Acetaminophens, Acetyl Salicylic Acid,
Other data
| Title | "Determination of Rasagiline Mesylate in dosage form and in human plasma and its application in bioequivalence study" | Other Titles | "تعيين رازاجلين ميزيلات في الجرعة الدوائية وفي البلازما وتطبيقها في دراسة للتكافؤ الحيوي" | Authors | Hassan Mohamed Hassan Soliman | Issue Date | 2017 |
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