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

Year 2016, Volume: 11 Issue: 1, 72 - 81, 24.05.2016

Zehra Üstün , Aybike Talay Ebru Çubuk Demiralay

Abstract

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.

Keywords

Method optimization, validation, simultaneous determination, atorvastatin, rosuvastatin

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

Abstract

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. 

Keywords

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

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