Öz
Amaç:
Bu çalışmada, rasekadotril’in farmasötik preparatlarda tayini için basit ve seçici yeni bir yüksek performanslı sıvı kromatografisi yöntemi geliştirilmiştir.
Yöntemler:
Yöntem ters fazlı C18 kolonda; asetonitril-su (70: 30, h/h) hareketli fazı ile 0,7 mL/minimum akış hızında rasekadotril’in kromatografik olarak analiz edilmesi esasına dayanır.
Bulgular:
Rasekadotril için en uygun dalga boyu 220 nm olarak belirlenmiştir. Rasekadotril için doğrusallık aralığı 5-100 μg/mL olarak bulunmuştur.
Sonuç:
Elde edilen sonuçlar istatistiksel olarak değerlendirildi. Geliştirilen yöntem kolay, kesin ve tekrarlanabilir olup rasekadotril’in farmasötik preparatlarının analizlerinde güvenle kullanılabilir.
Anahtar Kelimeler: Rasekadotril, ultra fast sıvı kromotografisi, farmasötik preparat analizi, validasyon, bozunma ürünleri
Kaynakça
Huilan S, Zhen LG, Mathan MM, Mathew MM, Olarte J, Espejo R, et al. Etiology of acute diarrhoea among children in developing countries: a multicentre study in five countries. Bull World Health Organ 1991;69:549-53.
Salazar-Lindo E, Santisteban-Ponce J, Chea-Woo E, Gutierrez M. Racecadotril in the treatment of acute watery diarrhea in children. N Engl J Med 2000;343:463-7.
Matheson AJ, Noble S. Racecadotril. Drugs 2000;59:829-35.
Vetrichelvan T, Prabakaran S. New spectrophotometric methods for the determination of racecadotril in bulk drug and capsules. Indian J Pharm Sci 2007;69:307-9.
Srinivasa Rao P, Nappinnai M. UV and RP-HPLC estimation of Racecadotril. Asian J Chem 2007;19:3697-702.
Prabhu S, Singh T, Kuma C, Joseph A, Srinivasan Kumar. High performance thin layer chromatographic method for analysis of racecadotril in the bulk drug. JPC-J Planar Chromat 2009;22:277-81.
Lakshmana Prabu S, Sing T, Joseph A, Dinesh Kumar C, Srinivasan KK. Stability indicating HPLC determination of racecadotril in bulk drug and pharmaceutical dosage form. Ars Pharm 2008;49:91-100.
Prabu SL, Singh T, Joseph A, Kumar CD, Shirwaikar A. Determination of Racecadotril by HPLC in Capsules. Indian J Pharm Sci 2007;69:819-21.
Xu F, Yang L, Xu G. A rapid and validated HPLC method to quantify racecadotril metabolite, thiorphan, in human plasma using solid-phase extraction. J Chromatogr B Analyt Technol Biomed Life Sci 2008;861:130-5.
Basnival PK, Srivastava PK, Jain SK, Jain D. RP-LC Analysis and Hydrolytic Degredation Profile of Racecadotril. Chromatographia 2008;68:641-7.
Haque A, Nasare M, Amrohi H, Satish S, Kumar J, Diwan V P. Stability indicating RP-HPLC method fort the estimation of Racecadotril in Pharmaceutical Dosage Form. Cell Tissue Res Cell Tissue Res 2012;12:3141-7.
Seshagiri Rao JVLN, Prakash PB, Krishna M, Kumar PR. RP-HPLC method fort he estimation of racecadotril in bulk and in tablets. Asian J Chem 2007;19:2623-6.
Laha TK, Patnaik R, Choudhury S, Sen S. Reverse phase high performance liquid chromatographic method for the analysis of racecadotril in pharmaceutical dosage forms. Asian J Chem 2008;20:2575-9.
Acharjya SK, Annapurna MM. Estimation of Acetorphan in pharmaceutical dosage forms by derivative spectrophotometry and liquid chromatographic methods. J Pharm Educ Res 2010;1:58-62.
ICH Q2 (R1), Validation of Analytical Procedures: Text and Methodology. Text in November 2005, Renamed Q2(R1),Implementation: Step 5
European Pharmacopoeia, Vol 9.0, Monographs Q-R, Pages 3472-3473
B. R. Gangadasu, G. Nagarjuna Reddy and K. Dhanalakshmi, Comparison of UPLC with UFLC: Liquid Chromatography, Int J Pharm Sci Rev Res 2015;31:97-101.
