A validated HPLC method for analysis of atorvastatin calcium in tablet dosage forms

Year 2013, Volume: 3 Issue: 4, 167 - 172, 30.01.2014

Şerife Hande Temir Bedia Koçyiğit Kaymakçıoğlu

Abstract

Objective: Atorvastatin is a member of the drug class known as statins, used for lowering blood cholesterol. Literature for the assay and impurity analysis of atorvastatin is usually combined with HPLC methods using UV or mass detection system. These methods are usually a gradient chromatographic separation method and a mobile phase containing buffer system using the provided stand out. In this study, an isocratic method was developed for which diclofenac sodium is used as internal standard for the determination of atorvastatin.

Method: The separation was carried out on C18 column using acetonitril and orthophosphoric acid (0.01%) (67:33 v/v) with isocratic separation using reversed phase high performance liquid chromatography.

Results: The retention times of atorvastatin calcium is 3.770±0.200 min and internal standard diclofenac sodium is 5.266±0.200 min. The method was optimized using a simple mobile phase; validation parameters such as linearity, accuracy, precision and LOD-LOQ were validated in terms. . 

Conclusion: The developed method is simple, sensitive and precise. The developed method can be used as a routine analysis for atorvastatin calcium.

Key words: Atorvastatin calcium, tablet, HPLC, validation

Keywords

Atorvastatin calcium, tablet, HPLC, validation

Atorvastatin kalsiyumun valide edilmiş HPLC metodu ile tablet formundan analizi

Abstract

Amaç: Atorvastatin kandaki kolesterolü düşürmek için kullanılan statin olarak bilinen ilaç sınıfının bir üyesidir. Atorvastatinin miktar tayini ve safsızlık analizleri için literatürlerde genellikle HPLC ile kombine edilmiş UV veya kütle dedektör sisteminin kullanıldığı yöntemler yer almaktadır. Bu yöntemlerde genellikle kromatografik ayırımın gradient bir metot ve tampon sistemi içeren bir mobil faz kullanılarak sağlandığı göze çarpmaktadır. Bu çalışmada atorvastatinin miktar tayini için diklofenak sodyumun internal standard olarak kullanıldığı ters faz sıvı kromatografisinde isokrotik bir metot geliştirilmiştir. 

Yöntem: Ters faz yüksek performanslı sıvı kromatografisi kullanılarak asetonitril ve % 0.01 ortofosforik asit (67:33 h/h) mobil fazı ile C18 kolonda isokrotik bir ayırım gerçekleştirilmiştir.

Bulgular: Atorvastatine ait alıkonma zamanı 3.770±0.200 dakika, internal standart olan diklofenaka ait alıkonma zamanı 5.266±0.200 dakikadır. Basit bir mobil faz kullanılarak metot optimize edilmiş; doğrusallık, kesinlik, doğruluk ve LOD-LOQ validasyon parametreleri açısından valide edilmiştir. 

Sonuç: Geliştirilen bu basit, hassas, duyarlı ve kesin yöntem atorvastatin kalsiyum için rutin analizlerde kullanılabilir.

Anahtar Kelimeler : Atorvastatin kalsiyum, tablet, HPLC, validasyon

Keywords

Atorvastatin kalsiyum, tablet, HPLC, validasyon

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