HPLC Analysis of Lamivudine in Pharmaceutical Formulations: Method Development and Validation

Yıl 2025, Cilt: 18 Sayı: 2, 537 - 548, 31.08.2025

Hüsniye Hande Aydın , Zeynep Ay Şenyiğit , Yesim Karasulu

https://doi.org/10.18185/erzifbed.1628542

Öz

We developed a novel, rapid and efficient high performance liquid chromatography (HPLC) method and validated to analyse the quantification of Lamivudine (LAM) in different pharmaceutical formulations, including pure form, commercial tablet, and nanostructured lipid carrier (NLC), a novel drug carrier system. Accurate analysis of the amount of active ingredient in pharmaceutical formulations is very important for assessment of the quality and therapeutic efficacy of formulations. In method, we used distilled water: methanol (MeOH) (60:40 v/v) as mobile phase and analysed on C18 column. To analyse the eluent, the method was performed at 270 nm, with a flow rate of 1 mL/min, in 10 min. The calibration curve obtained showed linearity in the concentration range 2-60 ppm. The average recovery of pharmaceutical preparations (Zeffix, GlaxoSmithKline tablets and NLC formulation) was 99.552%. Our method’s limit of detection (LOD) was 1.494 μg/mL. Our method’s limit of quantification (LOQ) was 0.514 μg/mL. The method also allowed the determination of the amount of LAM contained in the existing commercial formulation and the newly developed NLC formulation and the verification of the homogeneity of the pharmaceutical formulations. The results obtained show that the developed HPLC method can be used reliably in both formulation development and stability studies in NLC drug carrier systems.

Anahtar Kelimeler

Lamivudine , HPLC , Pharmaceutical Formulation , Nanostructured Lipid Carriers

Farmasötik Formülasyonlarda Lamivudinin HPLC Analizi: Yöntem Geliştirme ve Doğrulama

Öz

Yeni, hızlı ve etkili bir yüksek performanslı sıvı kromatografi (HPLC) yöntemi geliştirdik ve saf form, ticari tablet ve yeni bir ilaç olan nanoyapılı lipit taşıyıcı (NLC) dahil olmak üzere farklı farmasötik formülasyonlardaki Lamivudin (LAM) miktarının analiz edilmesi için doğrulandık. taşıyıcı sistem. Farmasötik formülasyonlardaki aktif madde miktarının doğru analizi, formülasyonların kalitesinin ve terapötik etkinliğinin değerlendirilmesi açısından çok önemlidir. Yöntemde mobil faz olarak distile su: metanol (MeOH) (60:40 v/v) kullanıldı ve C18 kolonunda analiz edildi. Eluenti analiz etmek için yöntem 270 nm'de, 1 mL/dakika akış hızıyla 10 dakikada gerçekleştirildi. Elde edilen kalibrasyon eğrisi 2-60 ppm konsantrasyon aralığında doğrusallık gösterdi. Farmasötik preparatların (Zefix®, GlaxoSmithKline tabletleri ve NLC formülasyonu) ortalama geri kazanımı %99,552 idi. Yöntemimizin tespit sınırı (LOD) 1,494 μg/mL idi. Yöntemimizin miktar sınırı (LOQ) 0,514 μg/mL idi. Yöntem aynı zamanda mevcut ticari formülasyonda ve yeni geliştirilen NLC formülasyonunda bulunan LAM miktarının belirlenmesine ve farmasötik formülasyonların homojenliğinin doğrulanmasına da olanak sağladı. Elde edilen sonuçlar, geliştirilen HPLC yönteminin NLC ilaç taşıyıcı sistemlerde hem formülasyon geliştirme hem de stabilite çalışmalarında güvenilir bir şekilde kullanılabileceğini göstermektedir.

Anahtar Kelimeler

Lamivudin , HPLC , Farmasötik Formülasyon , Nanoyapılı Lipid Taşıyıcılar

Etik Beyan

etik beyana gerek duyulmamıştır.

Kaynakça

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