Optimization of RPLC Conditions for Quantitative Analysis of Atorvastatin and Rosuvastatin in Pharmaceutical Dosage Form

Yıl 2016, Cilt: 11 Sayı: 1, 72 - 81, 24.05.2016

Zehra Üstün Aybike Talay Ebru Çubuk Demiralay

Öz

In this study, a simple reverse phase liquid chromatographic (RPLC) method has been developed and subsequently validated for simultaneous determination of atorvastatin (ATV) and
rosuvastatin (RSV). The column used was X Terra C18, (250 mm x 4.6 mm I.D., 5µm) with flow rate of 1 mL min-1 using photodiode array detection at 244 nm. The described method was linear over a concentration range of 3-13 µg mL-1 and 4-14 µg mL-1 for the assay of ATV and RSV respectively. Losartan was used as internal standard (IS) in the experiment. The limit of detection (LOD) values for ATV and RSV were found to be 0.133 and 0.221 µg mL-1 respectively. Limit of quantification (LOQ) for ATV and RSV were found to be 0.473 and 0.670 µg mL-1
, respectively. The results of the study showed that the proposed RPLC method is useful for the routine determination of ATV and RSV and in their pharmaceutical dosage form.

Anahtar Kelimeler

Method optimization, validation, simultaneous determination, atorvastatin, rosuvastatin

İlaç Dozaj Formunda Atorvastatin ve Rosuvastatinin kantitatif analizi için RPLC koşullarının optimizasyonu

Öz

Bu çalışmada, atorvastatin (ATV) ve rosuvastatinin (RSV) eş zamanlı tayini için ters faz sıvı kromatografi (RPLC) metodu geliştirilmiş ve valide edilmiştir. Ayırmada X Terra C18 (250 mm x 4,6
mm, 5µm) kolon kullanılmış ve 244 nm’ de yürütülen çalışmada akış hızı 1 mL dakika-1 olarak belirlenmiştir. Tanımlanan metodun doğrusal aralığı ATV için 3-13 µg mL-1 , RSV için 4-14 µg mL1 olarak belirlenmiştir. Deneyde iç standart (IS) olarak Losartan kullanılmıştır. ATV ve RSV için dedeksiyon limiti (LOD) değerleri sırasıyla 0,133 ve 0,221 µg mL-1 olarak hesaplanmıştır. Kantitasyon limiti (LOQ) değerleri ise ATV ve RSV için sırasıyla 0,473 ve 0,970 µg mL-1 olarak tayin edilmiştir. Elde edilen sonuçlara bakılarak, önerilen RPLC metodu ATV, RSV ve bunların farmasötik dozaj formlarının rutin analizlerinde kullanılabilir olduğu gözlemlenmiştir. 

Anahtar Kelimeler

Metot optimizasyonu, validasyon, eş zamanlı tayin, atorvastatin, rosuvastatin

Kaynakça

• [1] Lennernas, H., Foger, G.; Pharmacodynamics and pharmacokinetics of the HMG-CoA reductase inhibitors; Clinical Pharmacokinetics, (1997); 32: 403-425.
• [2] Sultana, N., Arayne, M.S., Shahzad, W.; Simultaneous determination of ceftriaxone sodium and statin drugs in pharmaceutical formulations and human serum by rp-hplc; Journal of the Chilean Chemical Society, (2010); 55; 193-198.
• [3]Chen, X., Xiong, F., Zheng, C., Li, J., Chen, F.; Synthetic studies on statins Part 3: A facile synthesis of rosuvastatin calcium through catalytic enantioselective allylation strategy; Tetrahedron, (2014); 70: 5794-5799.
• [4] Atorvastatin: Lipitor, www.medicinenet.com (accessed May 20, 2015).
• [5] Talay, A., Demiralay, E.Ç., Daldal, Y.D., Üstün, Z.; Investigation of thermodynamic acidity constants of some statins with RPLC method; Journal of Molecular Liquids, (2015); 208: 286-290.
• [6] Shah, Y., Iqbal, Z., Ahmad, L., Khan, A., Khan, M.I., Nazir, S., Nasir, F.; Simultaneous determination of rosuvastatin and atorvastatin in human serum using RP-HPLC/UV detection: Method development, validation and optimization of various experimental parameters; Journal of Chromatography B, (2011); 879: 557-563.
• [7] Venkata Ramana, G., Pavani, G., Supriya, P., Madhavi Latha, N.; Reversed Phase-High Performance liquid chromatography method development and validation of atorvastatin in bulk drug and formulation; Asian Journal of Pharmaceutical and Clinical Research, (2015); 8: 84-87.
• [8] Donthula, S., Kumar, M.K., Teja, G.S., Kumar, Y.M., Krishna, J.Y., Ramesh, D.; A new validated RP-HPLC method for determination of rosuvastatin calcium in bulk and pharmaceutical dosage form; Der Pharmacia Lettre, (2011); 3: 350-356.
• [9] Simionato, L.D., Ferello, L., Stamer, S.G., Repetto, M.F., Zubata, P.D. and Segall, A.I.; Validated Reversed-Phase HPLC Method for the Determination of Atorvastatin Calcium in Tablets; Austin Chromatography, (2014); 1(1): 1-4.
• [10] Janardhanan V.S. , Manavalan, R., Valliappan, K.; Chemometric technique for the optimization of chromatographic system: Simultaneous HPLC determination of Rosuvastatin, Telmisartan, Ezetimibe and Atorvastatin used in combined cardiovascular therapy; Arabian Journal of Chemistry, (2012); 2; 123-129.
• [11] Bhatia, N.M., Sachin, B.G., Swapnil, D.J., Bhatia, M.S., RP-HPLC method for estimation of atorvastatin calcium, losartan potassium, atenolol and aspirin from tablet dosage form and plasma; Journal of Liquid Chromatography & Related Technologies, (2012); 35(3); 428-443.
• [12] Gomes, F.P., Garcia, P.L., Alves, J.M.P., Singh, A.K., Hackmann, E.R., Santoro, M.I.; Development and validation of stability-indicating HPLC methods for quantitative determination of pravastatin, fluvastatin, atorvastatin and rosuvastatin in pharmaceuticals; Analytical Letters, (2009); 42: 1784- 1804.
• [13] Rondinini, S., Mussini, P.R, Mussini, T.; Reference value standards and primary standards for pH measurements in organic solvents and water+organic solvent mixtures of moderate to high permittivities; Pure and Applied Chemistry, (1987); 59: 1549-1560.
• [14] United States Pharmacopoeia and National Formulary (USP 34-NF29). Rockville, MD: US Pharmacopoeia 2011; p 3442-3443.