ZEHRA ÜSTÜN, Y. Doğan DALDAL, Aybike TALAY AYDOĞAN, EBRU ÇUBUK DEMİRALAY

Ters Faz Sıvı Kromatografi Yöntemiyle İlaç Formülasyonunda Pravastatin Tayini İçin Geliştirilmiş Optimizasyon Çalışması

Pravastatin, anti-kolesterol ajanlar grubuna dahil olan ve yüksek kolesterol tedavisinde kullanılan bir ilaçtır. Bu çalışmada pravastatinin tablet formulasyonundan tayini için ters faz sıvı kromatografi RPLC metodu tanımlanmıştır. Önerilen metot mobil faz pH’sında küçük değişiklik yapılarak geliştirilmiştir. Kromatografik ayrım C18 kolon kullanılarak, asetonitril-su 40:60, v/v ikili mobil faz karışımında gerçekleştirilmiştir. Akış hızının 1 mL/dakika olduğu çalışma 239 nm’de yürütülmüştür. Çalışmada lineer aralık 2-12 μg/mL olarak belirlenmiştir. Pravastatin için dedeksiyon limiti LOD ve kantitatif yorum limiti LOQ değerleri sırasıyla 0.260 μg/mL ve 0.787 μg/mL olarak olarak ölçülmüştür. Optimizasyon sonuçları, istatistiksel verilerle birlikte değerlendirildiğinde metodun güvenilirliğini ortaya koymaktadır

Anahtar Kelimeler:

Anti-kolesterol ajanlar, Farmasötik dozaj form, RPLC, UV dedeksiyon

An Improved Optimization Study for Determination of Pravastatin in Pharmaceutical Form by using Reversed Phase Liquid Chromatography Method

Pravastatin belongs to the group of anticholestrol agents used in the treatment of hypercholestaraemia. Reversed phase liquid chromatographic RPLC method was described in this study for its determination from tablet formulation. This method was improved with a slight change in the pH of the mobile phase. The experiment was carried out a C18 column with a mobile phase of a binary mixture of acetonitrile and water 40:60, v/v delivered at a flow rate of 1 mL/min and detection was carried out at 239 nm. The linear range was found as 2 - 12 μg/mL. The lower of quantitation LOQ for pravastatin was 0.787 µg/mL. The optimization results, together with statistical evaluation of the data, demonstrated the reliability of this method.

Keywords:

Anticholestrol agents, Reversed Phase Liquid Chromatography RPLC, UV detection, Pharmaceutical dosage form,

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