SavedAdd your journal

Journals / Hacettepe Üniversitesi Eczacılık Fakültesi Dergisi / 2013 / Sayı: 1

Forced Degradation Profiling of Artemether by Validated Stability-Indicating RP-HPLC-DAD Method

Artemether’ in Stres Bozundurma Profilinin Stabilite Göstergeli Valide Edilmiş RP-HPLC-DAD Metoduyla Belirlenmesi

Deepti JAİN
Pawan Kumar BASNİWAL
Pages
41–58
Publication Date
2013-01-01
DOI
—
🏛️Bibliographic metadata and full text access for this article are provided via DergiPark.
DergiPark Record ↗
✨

AI Summary & Key Takeaways

AI Insight
⚡ TL;DR(Too Long; Didn't Read)

The validated RP-HPLC-DAD method may be applied for impurity profiling, quality control for purity of drug, routine analysis in pharmaceutical industry, bioequivalence and dissolution studies.

📌 3 Key Takeaways

🎯
Objective & Hypothesis:A novel stability-indicating RP-HPLC method for artemether has been developed and validated as per ICH guidelines and applied successfully to establish inherent stability of the drug by performing forced degradation in different stress conditions.
📊
Key Findings & Data:The chromatographic separation of artemether and its degradants was achieved on Zorbax Eclipse Plus C18 column 250 × 4.6 mm, 5 μm by employing the mixture of acetonitrile and water 70:30 at 13.48 min with 1.0 μL/min flow rate.
💡
Conclusion & Impact:The validated RP-HPLC-DAD method may be applied for impurity profiling, quality control for purity of drug, routine analysis in pharmaceutical industry, bioequivalence and dissolution studies.
🔬Design:Research Article
📍Scope:Comprehensive Sample
⚙️Variables:Artemether · Stres Bozundurma Profili · RP-HPLCDAD

Abstract

A novel stability-indicating RP-HPLC method for artemether has been developed and validated as per ICH guidelines and applied successfully to establish inherent stability of the drug by performing forced degradation in different stress conditions. The chromatographic separation of artemether and its degradants was achieved on Zorbax Eclipse Plus C18 column 250 × 4.6 mm, 5 μm by employing the mixture of acetonitrile and water 70:30 at 13.48 min with 1.0 μL/min flow rate. The detection was performed by photodiode-array detector at 216 nm and room temperature was monitored for column. The degradation behavior drug was determined by performing forced degradation profile viz. hydrolysis, oxidation, photolysis and thermal decomposition. Extensive degradation was found in hydrolytic conditions neutral, acid and alkaline , while it was stable under temperature 60 °C , UV irradiation and in hydrogen peroxide solution 3 and 10% . The validated RP-HPLC-DAD method may be applied for impurity profiling, quality control for purity of drug, routine analysis in pharmaceutical industry, bioequivalence and dissolution studies.

Özet

Artemether için yeni bir stabilite göstergeli RP-HPLC method geliştirilmiştir ve ICH kılavuzlarına göre valide edilmiştir. Geliştirilen yöntem farklı stres koşullarında Artemether’ in kararlılığını göstermek için kullanılmıştır. Artemether ve bozunma ürünlerinin ayrımı Zorbax Eclipse Plus C18 kolon 250 × 4.6 mm, 5 μm kullanılarak asetonirtil ve su 70:30 karışımı ile 1.0 mL/dak akış hızında 13.48 dakikada gerçekleştirilmiştir. Dedeksiyon, dizi diyot dedektör aracılığıyla 216 nm dalga boyunda gerçekleştirilmiştir ve kolon oda sıcaklığında tutulmuştur. Artemether’in bozunma davranışı stres koşullarında hidroliz, oksidasyon, fotoliz ve termal bozunma uygulanarak incelenmiştir. Düşük sıcaklıklarda 60 °C kararlı olan Artemether için sulu ortamda nötr, asidik, bazik , UV ışık altında ve hidrojen peroksit %3 - %10 ortamında bozunma gözlenmiştir. Geliştirilen valide edilmiş RP-HPLC yöntemi, impürüte profillenmesinde, ilacın kalite kontrolünde, ilaç sanayisinde rutin analizlerde, biyoeşdeğerlik çalışmalarında ve dissolüsyon çalışmalarında kullanılabilir.

🔖

Cite This Article

JAİN, D., BASNİWAL, P. K. (2013). Forced Degradation Profiling of Artemether by Validated Stability-Indicating RP-HPLC-DAD Method. Hacettepe Üniversitesi Eczacılık Fakültesi Dergisi, Sayı: 1, 41–58. https://ajindex.com/articles/762370

📄 Full Text PDF Viewer

📄

PDF görüntüleyici hazırlanıyor...

References (10)

  1. World Health Organization (WHO) website: http://www.who.int/malaria/ publica- tions/ world_ malaria_report_2012/en/index.html (08.04.2013)
  2. Stringham, R.W., Lynam, K.G., Mrozinski, P. et al.: High performance liquid chromato- graphic evaluation of artemisinin, raw material in the synthesis of artesunate and artemether, J Chromatogr A 1216, 8918–8925 (2009).
  3. Mohamed, S.A., Khalid, S.A. Ward, et al.: Simultaneous determination of artemether and its major metabolite dihydroartemisinin in plasma by gas chromatography–mass spectrometry-selected ion monitoring, J Chromatogr B 731, 251–260 (1999).
  4. Wiesner, L., Govender, K., Meredith, S.A. et al.: A liquid–liquid LC/MS/MS assay for the determination of artemether and DHA in malaria patient samples, J Pharm Biomed Ana 55, 373–378 (2011).
  5. Souppart, C., Gauducheau, N., Sandrenan, N. et al.: Development and validation of a high-performance liquid chromatography–mass spectrometry assay for the determina- tion of artemether and its metabolite dihydroartemisinin in human plasma, J Chro- matogr B 774, 195–203 (2002). Magalhães, I.R.S., Jabor, V.A.P., Faria, A.M., et al.: Determination of -artemether and its main metabolite dihydroartemisinin in plasma employing liquid-phase microextrac- tion prior to liquid chromatographic–tandem mass spectrometric analysis, Talanta 81, 941–947 (2010).
  6. Huang, L., Jayewardene, A.L., Li, X., et al.: Development and validation of a high- performance liquid chromatography/tandem mass spectrometry method for the deter- mination of artemether and its active metabolite dihydroartemisinin in human plasma, J Pharm Biomed Ana 50, 959–965 (2009).
  7. Navaratnam, V., Mansor, S.M., Chin, L.K., et al.: Determination of artemether and dihydroartemisinin in blood plasma by high-performance liquid chromatography for application in clinical pharmacological studies, J Chromatogr B 669, 289-294 (1995).
  8. Sandrenan, N., Sioufi, A., Godbillon, J., et al.: Determination of artemether and its me- tabolite, dihydroartemisinin, in plasma by high-performance liquid chromatography and electrochemical detection in the reductive mode, J Chromatogr B 691, 145-153 (1997).
  9. Karbwang, J., Na-Bangchang, K., Molunto, P., et al.: Determination of artemether and its major metabolite, dihydroartemisinin, in plasma using high-performance liquid chromatography with electrochemical detection, J Chromatogr B 690, 259-265 (1997).
  10. Thomas, C.G., Ward, S.A., Edwards, G.: Selective determination, in plasma, of arte- mether and major metabolite