ABSTRACT
Objective:To establish an HPLC method for the determination of the related substances in nimesulide granules. Meth-ods:An Agilent HC-C18(250 mm ×4.6 mm,5 μm)column was used, the mobile phase was composed of acetonitrile-0.01 mol ·L-1 ammonium dihydrogen phosphate (adjusting pH to 7. 0 with ammonia) (40:60) and the detection wavelength was 230 nm, the flow rate was 1. 0 ml·min-1 ,the column temperature was 30℃, and the injection volume was 20μl. Results:The linear range of nimesu-lide was 0. 10-0. 30 mg·ml-1(r=0. 999 9). Nimesulide and its related substances could be well separated with the peak separation degree above 2. 0. The limit of detection and the limit of quantification was 0. 3 ng and 1. 0 ng, respectively. Conclusion:The method is simple, accurate and reproducible, which can be used for the quality control of nimesulide granules.
ABSTRACT
Objective:To evaluate the bioequivalence of two kinds of domestic nimesulide granules in healthy volunteers. Meth-ods:In self-control and two-way crossover design, 18 healthy male volunteers were divided into two groups randomly. Each subject was given 100 mg test or reference nimesulide granules with single dose. The concentration of nimesulide in plasma was determined by HPLC. The concentration of nimesulide in plasma was calculated and compared statistically to evaluate the bioequivalence between the two kinds of granules by DAS 2. 1 software. Results:The main pharmacokinetic parameters of test and reference preparations were as follows:Cmax was(9. 28 ± 2. 05) and(9. 41 ± 2. 31)μg·ml-1;Tmax was(3. 50 ± 1. 86)and(3. 56 ± 1. 65)h;T1/2 was (3. 43 ± 0. 85) and(3.38 ±0.68)h;AUC0-24 was(77.78 ±18.42)and(81.69 ±23.50)μg·ml·h-1;AUC(0-∞) was (79.07 ±19.21)and(82.92 ± 24. 11)μg·ml·h-1, respectively. The 90% confidential interval of ln(AUC0-24), ln(AUC0-∞) and ln(Cmax) of the test preparation was 90. 7%-107. 9%,90. 6%-111. 2% and 90. 7%-103. 0%, respectively. The relative bioavailability was (96. 7 ± 37. 6)%. Con-clusion:The two nimesulide granules are bioequivalent.
ABSTRACT
Objective:To establish a method for the determination of nimesulide granules by HPLC. Methods:An Inertsil ODS-SP C18 column(250 mm × 4. 6 mm,5 μm) was used, and the mobile phase was 0. 01 mol·L-1 potassium hydrogen phosphate anhy-drous-acetonitrile(55∶45)[adjusting pH to (7. 2 ± 0. 05) with phosphoric acid]. The detection wavelength was set at 399nm and the flow rate was 1.0 ml·min-1. The injection volume was 20 μl. Results: The linear range of nimesulide was 0.044-0.222 μg(r=0. 999 9), the average recovery was 99. 22% and RSD was 0. 46%(n=6). Conclusion:The method is simple, accurate with promis-ing sensitivity and reproducibility, and can be used in the determination of nimesulide granules .