Farmasötik Dozaj Formlarında Levodopa ve Karbidopa’nın Eşzamanlı Tayini için bir HPLC yönteminin geliştirilmesi

Year 2021, , 221 - 227, 01.12.2021

Osman Mohamed Shaza Shantier , Iman Abureid Elrasheed Gadkariem

https://doi.org/10.52794/hujpharm.1006726

Abstract

Çok bileşenli analiz, farmasötik kalite kontrol analizinde büyük bir zorluk teşkil etmiştir. Bu nedenle, mevcut çalışmada, levodopa ve karbidopa'nın toplu ve tablet biçiminde eşzamanlı tayini için seçici, doğru ve kesin bir sıvı kromatografik yöntem (HPLC) geliştirilmiştir. En iyi çözünürlük, mobil faz 1 akış hızında pompalanırken fosfat tamponu pH 2.8 ve asetonitril (95: 5 v/v) karışımı kullanılarak bir C18 kolonunda (5 um partikül boyutu, 250 mm x 4.6 mm ID) elde edildi. ml/dak. Oluşturulan kalibrasyon eğrileri, 1.0'a yakın korelasyon katsayıları ile konsantrasyon aralığında (sırasıyla levodopa ve karbidopa için 25-250 μg/ml ve 2.5 – 25 μg/ml) doğrusaldı. Geliştirilen yöntemin doğruluğu ve kesinliği çok iyiydi (RSD ˂ %2). Önerilen yöntemin geçerliliği, elde edilen verilerin resmi USP yöntemininkilerle istatistiksel olarak karşılaştırılması yoluyla doğrulandı. Geliştirilen yöntemin levodopa ve karbidopanın eş zamanlı analizi için doğru ve geçerli olduğu kanıtlanmıştır.

Keywords

Kromatografi, HPLC, Levodopa, Karbidopa, Resmi yöntem, Doğrulama

Development of an HPLC Method for the Simultaneous Determination of Levodopa and Carbidopa in Pharmaceutical Dosage Forms

Abstract

Multicomponent analysis has presented a great challenge in pharmaceutical quality control analysis. Thus, in the present work, a selective, accurate and precise liquid chromatographic method (HPLC) has been developed for the simultaneous determination of levodopa and carbidopa in bulk and tablet form. The best resolution was achieved on a C18 column (5 µm particle size, 250 mm×4.6 mm I.D.) using a mixture of phosphate buffer pH 2.8 and acetonitrile (95: 5 v/v) as the mobile phase pumped at a flow rate of 1 ml/min. The constructed calibration curves were linear in the concentration range (25˗250 μg/ml and 2.5 – 25 μg/ml for levodopa and carbidopa, respectively) with correlation coefficients close to 1.0. The accuracy and the precision of the developed method were very good (RSD ˂ 2%). The validity of the proposed method was confirmed through the statistical comparison of the obtained data with those of the official USP method. The developed method proved to be accurate and valid for the simultaneous analysis of levodopa and carbidopa.

Keywords

Chromatography, HPLC, Levodopa, Carbidopa, Official method, Validation

References

• 1. Wisher D. (2012) Martindale: The complete drug reference. Journal of the Medical Library Association. 100 (1):75-7.
• 2. British Pharmacopeia (2017), volume III. London: stationery office. pp. 393-393.
• 3. The United States pharmacopeia convention, (2016) National formula (34th ed.), pp. 2925
• 4. Kumar SS, Natraj K, Khan A, Kumar BK, Rao J. Development and Validation of RP-HPLC Method for Simultaneous Estimation of Levodopa and Carbidopa in Pharmaceutical Dosage Forms. Journal of Pharmacy Research Vol. 2011;4(11):4060-2.
• 5. Sravanthi D, Anusha M, Madhavi S, Firdose S, Nalluri BN. Simultaneous Estimation of Levodopa and Carbidopa in Bulk, Pharmaceutical Dosage Forms and Dissolution Sample Analysis by RP-HPLC-PDA Method. Journal of Chemical and Pharmaceutical Research. 2013;5:422-8.
• 6. Elbashir AA, Bashir BEA, Aboul-Enein HY. Development and Validation of Spectrophotometric Method for the Determination of Levodopa (L-Dopa) In Pharmaceutical Formulations. 2016.
• 7. Raut PP, Charde SY. Simultaneous estimation of levodopa and carbidopa by RP‐HPLC using a fluorescence detector: its application to a pharmaceutical dosage form. Luminescence. 2014;29(7):762-71.
• 8. Patel M. Development and Validation of Simultaneous Estimation of Two Catecholamines in Combined Dosage Form by HPTLC Method. Asian Journal of Pharmaceutical Analysis. 2014;4(2):57-77.
• 9. Khanmohammadi M, Mobedi E, Garmarudi AB, Mobedi H, Kargosha K. Simultaneous determination of levodopa and carbidopa in levodopa-carbidopa tablets by ATR-FTIR spectrometry. Pharmaceutical development and technology. 2007;12(6):573-80.
• 10. Sima IA, Casoni D, Sârbu C. Simultaneous determination of carbidopa and levodopa using a new TLC method and a free radical as a detection reagent. Journal of Liquid Chromatography & Related Technologies. 2013;36(17):2395-404.
• 11. Miller R, Dehelean L, Belanger L. Determination of carbidopa and levodopa in human plasma by high-performance liquid chromatography with electrochemical detection. Chromatographia. 1993;35(9):607-12.
• 12. Madrakian T, Afkhami A, Borazjani M, Bahram M. Simultaneous derivative spectrophotometric determination of levodopa and carbidopa in pharmaceutical preparations. Bulletin of the Korean Chemical Society. 2004;25(12):1764-8.
• 13. ICH G. Validation of analytical procedures: text and methodology. 2005, Q2 (R1).1.
• 14. Elimam MM, Shantier SW, GadkariemEA, Mohamed MA. Derivative Spectrophotometric Methods for the Analysis and Stability Studies of Colistin Sulphate Journal of Chemistry, 2015; Article ID 624316, 5