Stolarczyk Mariusz, Apola Anna, Maślanka Anna, Kwiecień Anna, Opoka Włodzimierz
1Department of Inorganic and Analytical Chemistry Jagiellonian University Medical College, Faculty of Pharmacy 30-688 Kraków, Poland.
Acta Pharm. 2017 Dec 20;67(4):463-478. doi: 10.1515/acph-2017-0031.
Applicability of derivative spectrophotometry for the determination of valsartan in the presence of a substance from the group of statins was checked. The obtained results indicate that the proposed method may be effective by using appropriate derivatives: for valsartan and fluvastatin - D1, D2 and D3, for valsartan and pravastatin - D1 and D3, for valsartan and atorvastatin - D2 and D3. The method was characterized by high sensitivity and accuracy. Linearity was maintained in the following ranges: 9.28-32.48 mg mL-1 for valsartan, 8.16-28.56 mg mL-1 f or fluvastatin, 14.40-39.90 mg mL-1 for atorvastatin and 9.60-48.00 mg mL-1 for pravastatin. Determination coefficients were in the range of 0.989-0.999 depending on the analyte and the order of derivative. The precision of the method was high with RSD from 0.1 to 2.5 % and recovery of individual components was within the range of 100 ± 5 %. The developed method was successfully applied to the determination of valsartan combined with fluvastatin, atorvastatin and pravastatin in laboratory prepared mixtures and in pharmaceutical preparations.
考察了导数分光光度法在他汀类药物存在下测定缬沙坦的适用性。所得结果表明，使用适当的导数，该方法可能有效：对于缬沙坦和氟伐他汀，使用D1、D2和D3；对于缬沙坦和普伐他汀，使用D1和D3；对于缬沙坦和阿托伐他汀，使用D2和D3。该方法具有高灵敏度和准确性。线性范围如下：缬沙坦为9.28 - 32.48 mg mL-1，氟伐他汀为8.16 - 28.56 mg mL-1，阿托伐他汀为14.40 - 39.90 mg mL-1，普伐他汀为9.60 - 48.00 mg mL-1。根据分析物和导数阶数，测定系数在0.989 - 0.999范围内。该方法精密度高，相对标准偏差为0.1%至2.5%，各组分回收率在100±5%范围内。所建立的方法成功应用于实验室配制混合物及药物制剂中缬沙坦与氟伐他汀、阿托伐他汀和普伐他汀的测定。
