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Development and Validation of HPLC Method for the Determination of Flurbiprofen in Pharmaceutical Preparations

Yıl 2022, Cilt: 2 Sayı: 3, 72 - 81, 06.07.2022

Öz

Bu çalışmada, saf ve farmasötik preparatlarda flurbiprofen tayini için yeni ve hızlı yüksek performanslı sıvı kromatografisi (HPLC) yöntemi geliştirilmiştir. Yöntem, fosforik asit ile pH 3.5'e ayarlanmış bir asetonitril-0.05 M potasyum dihidrojen fosfat çözeltisinin (60:40, v/v) mobil fazı kullanılarak Ace C18 kolonu üzerinde geliştirildi. Eluent 254 nm'de UV dedektör ile izlendi. Analiz, 1.0 mL dak-1 akış hızıyla 6 dakikadan daha kısa sürede gerçekleştirildi. Kalibrasyon eğrisi 0.10-5.0 μg mL-1 konsantrasyon aralığında doğrusaldı. Flurbiprofen için gün içi ve günler arası kesinlik değerleri 4.56'dan azdı ve doğruluk (bağıl hata) %4.00'den daha iyiydi. Farmasötik preparatlar için flurbiprofenin ortalama geri kazanımı %99.8 idi. Gözlenebilme (LOD) ve miktar tayin (LOQ) limitleri sırasıyla 0,03 ve 0,10 µg mL-1 idi. Ayrıca yöntem ilacın miktar tayinini yapmak ve formülasyon içeriği tekdüzeliğini kontrol etmek için iki ticari flurbiprofen dozaj formunun kalite kontrolü için uygulandı.

Kaynakça

  • 1. Townsend, K.P., Pratico, D.; Novel therapeutic opportunities for Alzheimer’s disease: focus on nonsteroidal anti-inflammatory drugs, The FASEB Journal, (2005); 19: 1592-1601.
  • 2. Vega, E., Egea, M.A., Garduno-Ramírez, M.L., García, M.L., Sánchez, E., Espina, M., Calpena, A.C.; Flurbiprofen PLGA-PEG nanospheres: Role of hydroxy--cyclodextrinon ex vivo human skin permeation and in vivo topicalanti-inflammatory efficacy, Colloids and Surfaces B: Biointerfaces, (2013); 110: 339-346.
  • 3. Tamborini, L., Romano, D., Pinto, A., Bertolani, A., Molinari, F., Conti, P.; An efficient method for the lipase-catalysed resolution and in-line purification of racemic flurbiprofen in a continuous-flow reactor, Journal of Molecular Catalysis B: Enzymatic, (2012); 84: 78-82.
  • 4. Murali Mohan Babu, G.V., Prasad, C.D.S., Hima Sankar, K., Gouri Sankar, V., Kishore Kumar, N. Ramana Murthy, K.V.; Development of new controlled release formulation of flurbiprofen: in vitro-in vivo correlation, Indian Journal of Pharmaceutical Sciences, (2002); 64: 37-43.
  • 5. Kagkadis, K.A., Rekkas, D.M., Dallas, P.P., Choulis, N.H.; A freeze-dried injectable form of flurbiprofen: development and optimisation using response surface methodology, International Journal of Pharmaceutics, (1998); 161: 87-94.
  • 6. Muraoka, A., Tokumura, T., Machida, Y.; Evaluation of the bioavailability of flurbiprofen and its β-cyclodextrin inclusion complex in four different doses upon oral administration to rats, The European Journal of Pharmaceutics and Biopharmaceutics, (2004); 58: 667-671.
  • 7. Poul, J., West, J., Buchanan, N., Grahame, R.; Local action transcutaneous flurbiprofen in the treatment of soft tissue rheumatism, British Journal of Pharmacology, (1993); 32: 1000-1003.
  • 8. Guo, C.C., Tang, Y.H., Hu, H.H., Yu, L.S., Jiang, H.D., Zeng, S.; Analysis of chiral non-steroidal anti-inflammatory drugs flurbiprofen, ketoprofen and etodolac binding with HSA, Journal of Pharmaceutical Analysis, (2011); 1: 184-190.
  • 9. Askholt, J., Nielsen-Kudsk, F.; Rapid HPLC-determination of ibuprofen and flurbiprofen in plasma for therapeutic drug control and pharmacokinetic applications, Acta Pharmacologica et Toxicologica, (1986); 59: 382-386.
  • 10. Chi, S.C., Kim, H., Lee, SC.; High performance liquid chromatographic. analysis of flurbiprofen in rat plasma, Analytical Letters, (1994); 27: 377-389.
  • 11. Johnson, V.A., Wilson, J.T.; Flurbiprofen analysis in plasma and breast milk by high-performance liquid chromatography, Journal of Chromatography, (1986); 382: 897-901.
  • 12. Adams, W.J., Bothwell, B.E., Bothwell, W.M., VanGiessen, G.J., Kaiser, D.G.; Simultaneous determination of flurbiprofen and its major metabolite in physiological fluids using liquid chromatography with fluorescence detection. Analytical Chemistry, (1987); 59: 1504-1509.
  • 13. Hutzler, J.M., Fyre, R.F., Tracy, T.S.; Sensitive and specific high-performance liquid chromatographic assay for 49-hydroxyflurbiprofen and flurbiprofen in human urine and plasma, Journal of Chromatography B, (2000); 749: 119-125.
  • 14. Kang, J.H., Oh, D.H., Oh, Y.K., Yong, C.S., Choi, H.G.; Effects of solid carriers on the crystalline properties, dissolution and bioavailability of flurbiprofen in solid self-nanoemulsifying drug delivery system (solid SNEDDS). European Journal of Pharmaceutics and Biopharmaceutics, (2012); 80: 289-297.
  • 15. Pe’hourcq, F., Jarry, C., Bannwarth, B.; Chiral resolution of flurbiprofen and ketoprofen enantiomers by HPLC on a glycopeptide-type column chiral stationary phase, Biomedical Chromatography, (2001); 15: 217-222.
  • 16. Geisslinger, G., Menzel-Soglowek, S., Schuster O., Brune, K.; Stereoselective high-performance liquid chromatographic determination of flurbiprofen in human plasma, Journal of Chromatography, (1992); 573: 163-167.
  • 17. Knadler, M.P., Hall, S.D.; High performance liquid chromatography analysis of the enantiomers of flurbiprofen and its metabolites in plasma and urine, Journal of Chromatography, (1989); 494: 173-182.
  • 18. Hirai, T., Matsumoto, S., Kishi, I.; Simultaneous analysis of several non-steroidal antiinflammatory drugs in human urine by high-performance liquid chromatography with normal solid-phase extraction, Journal of Chromatography B, (1997); 692: 375-388.
  • 19. Riegel, M., Ellis, P.P.; High-performance liquid chromatographic assay for antiinflammatory agents diclofenac and flurbiprofen in ocular fluids, Journal of Chromatography B, (1994); 654: 140-145.
  • 20. Mano, N., Narui, T., Nikaido, A., Goto, J.; Separation and determination of diastereomeric flurbiprofen acyl glucuronides in human urine by LC/ESI-MS with a simple column-switching technique, Drug Metabolism and Pharmacokinetics, (2002); 17: 142-149.
  • 21. United States Pharmacopoeia, United States Pharmacopoeial Convention, 24th Edition, Rockville, MD, (2000) 748-750.
  • 22. British Pharmacopoeia, British Pharmacopoeial Commission, London, (1993) 292-293.
  • 23. The Pharmacopoeia of India, Indian Pharmacopoeial Commission, New Delhi, (1996) 328-329.
  • 24. International Conference on Harmonisation (ICH) of Technical requirements for Registration of Pharmaceuticals for Human Use: Harmonised Tripartite Guideline on Validation of Analytical Procedures: Methodology, Recommended for Adoption at Step 4 of the ICH Process on November by the ICH Steering Committee, Published by IFPMA, Switzerland, (1996).
  • 25. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layoff T, Vishwanathan CT, Cork CE, McDowall RD, Pitman KA, Spector S (1992) 9Analytical method validation: bioavailability, bioequivalence, and pharmacokinetics studies. Pharma Res 588-592.
  • 26. Beaulieu N, Cyr TD, Lovering EG (1991) Validation of methods for the assay of flurbiprofen and flurbiprofen sodium, related compounds and volatile impurities in raw materials and tablets. Drug Develop Industrial Pharm 17:1843-1855.
  • 27. Mathew M, Das Gupta V, Bethea C (1993) Quantitation of flurbiprofen in tablets using high performance liquid chromatography. Drug Develop Industrial Pharm 19:493-498.
Yıl 2022, Cilt: 2 Sayı: 3, 72 - 81, 06.07.2022

Öz

Destekleyen Kurum

Yok

Kaynakça

  • 1. Townsend, K.P., Pratico, D.; Novel therapeutic opportunities for Alzheimer’s disease: focus on nonsteroidal anti-inflammatory drugs, The FASEB Journal, (2005); 19: 1592-1601.
  • 2. Vega, E., Egea, M.A., Garduno-Ramírez, M.L., García, M.L., Sánchez, E., Espina, M., Calpena, A.C.; Flurbiprofen PLGA-PEG nanospheres: Role of hydroxy--cyclodextrinon ex vivo human skin permeation and in vivo topicalanti-inflammatory efficacy, Colloids and Surfaces B: Biointerfaces, (2013); 110: 339-346.
  • 3. Tamborini, L., Romano, D., Pinto, A., Bertolani, A., Molinari, F., Conti, P.; An efficient method for the lipase-catalysed resolution and in-line purification of racemic flurbiprofen in a continuous-flow reactor, Journal of Molecular Catalysis B: Enzymatic, (2012); 84: 78-82.
  • 4. Murali Mohan Babu, G.V., Prasad, C.D.S., Hima Sankar, K., Gouri Sankar, V., Kishore Kumar, N. Ramana Murthy, K.V.; Development of new controlled release formulation of flurbiprofen: in vitro-in vivo correlation, Indian Journal of Pharmaceutical Sciences, (2002); 64: 37-43.
  • 5. Kagkadis, K.A., Rekkas, D.M., Dallas, P.P., Choulis, N.H.; A freeze-dried injectable form of flurbiprofen: development and optimisation using response surface methodology, International Journal of Pharmaceutics, (1998); 161: 87-94.
  • 6. Muraoka, A., Tokumura, T., Machida, Y.; Evaluation of the bioavailability of flurbiprofen and its β-cyclodextrin inclusion complex in four different doses upon oral administration to rats, The European Journal of Pharmaceutics and Biopharmaceutics, (2004); 58: 667-671.
  • 7. Poul, J., West, J., Buchanan, N., Grahame, R.; Local action transcutaneous flurbiprofen in the treatment of soft tissue rheumatism, British Journal of Pharmacology, (1993); 32: 1000-1003.
  • 8. Guo, C.C., Tang, Y.H., Hu, H.H., Yu, L.S., Jiang, H.D., Zeng, S.; Analysis of chiral non-steroidal anti-inflammatory drugs flurbiprofen, ketoprofen and etodolac binding with HSA, Journal of Pharmaceutical Analysis, (2011); 1: 184-190.
  • 9. Askholt, J., Nielsen-Kudsk, F.; Rapid HPLC-determination of ibuprofen and flurbiprofen in plasma for therapeutic drug control and pharmacokinetic applications, Acta Pharmacologica et Toxicologica, (1986); 59: 382-386.
  • 10. Chi, S.C., Kim, H., Lee, SC.; High performance liquid chromatographic. analysis of flurbiprofen in rat plasma, Analytical Letters, (1994); 27: 377-389.
  • 11. Johnson, V.A., Wilson, J.T.; Flurbiprofen analysis in plasma and breast milk by high-performance liquid chromatography, Journal of Chromatography, (1986); 382: 897-901.
  • 12. Adams, W.J., Bothwell, B.E., Bothwell, W.M., VanGiessen, G.J., Kaiser, D.G.; Simultaneous determination of flurbiprofen and its major metabolite in physiological fluids using liquid chromatography with fluorescence detection. Analytical Chemistry, (1987); 59: 1504-1509.
  • 13. Hutzler, J.M., Fyre, R.F., Tracy, T.S.; Sensitive and specific high-performance liquid chromatographic assay for 49-hydroxyflurbiprofen and flurbiprofen in human urine and plasma, Journal of Chromatography B, (2000); 749: 119-125.
  • 14. Kang, J.H., Oh, D.H., Oh, Y.K., Yong, C.S., Choi, H.G.; Effects of solid carriers on the crystalline properties, dissolution and bioavailability of flurbiprofen in solid self-nanoemulsifying drug delivery system (solid SNEDDS). European Journal of Pharmaceutics and Biopharmaceutics, (2012); 80: 289-297.
  • 15. Pe’hourcq, F., Jarry, C., Bannwarth, B.; Chiral resolution of flurbiprofen and ketoprofen enantiomers by HPLC on a glycopeptide-type column chiral stationary phase, Biomedical Chromatography, (2001); 15: 217-222.
  • 16. Geisslinger, G., Menzel-Soglowek, S., Schuster O., Brune, K.; Stereoselective high-performance liquid chromatographic determination of flurbiprofen in human plasma, Journal of Chromatography, (1992); 573: 163-167.
  • 17. Knadler, M.P., Hall, S.D.; High performance liquid chromatography analysis of the enantiomers of flurbiprofen and its metabolites in plasma and urine, Journal of Chromatography, (1989); 494: 173-182.
  • 18. Hirai, T., Matsumoto, S., Kishi, I.; Simultaneous analysis of several non-steroidal antiinflammatory drugs in human urine by high-performance liquid chromatography with normal solid-phase extraction, Journal of Chromatography B, (1997); 692: 375-388.
  • 19. Riegel, M., Ellis, P.P.; High-performance liquid chromatographic assay for antiinflammatory agents diclofenac and flurbiprofen in ocular fluids, Journal of Chromatography B, (1994); 654: 140-145.
  • 20. Mano, N., Narui, T., Nikaido, A., Goto, J.; Separation and determination of diastereomeric flurbiprofen acyl glucuronides in human urine by LC/ESI-MS with a simple column-switching technique, Drug Metabolism and Pharmacokinetics, (2002); 17: 142-149.
  • 21. United States Pharmacopoeia, United States Pharmacopoeial Convention, 24th Edition, Rockville, MD, (2000) 748-750.
  • 22. British Pharmacopoeia, British Pharmacopoeial Commission, London, (1993) 292-293.
  • 23. The Pharmacopoeia of India, Indian Pharmacopoeial Commission, New Delhi, (1996) 328-329.
  • 24. International Conference on Harmonisation (ICH) of Technical requirements for Registration of Pharmaceuticals for Human Use: Harmonised Tripartite Guideline on Validation of Analytical Procedures: Methodology, Recommended for Adoption at Step 4 of the ICH Process on November by the ICH Steering Committee, Published by IFPMA, Switzerland, (1996).
  • 25. Shah VP, Midha KK, Dighe S, McGilveray IJ, Skelly JP, Yacobi A, Layoff T, Vishwanathan CT, Cork CE, McDowall RD, Pitman KA, Spector S (1992) 9Analytical method validation: bioavailability, bioequivalence, and pharmacokinetics studies. Pharma Res 588-592.
  • 26. Beaulieu N, Cyr TD, Lovering EG (1991) Validation of methods for the assay of flurbiprofen and flurbiprofen sodium, related compounds and volatile impurities in raw materials and tablets. Drug Develop Industrial Pharm 17:1843-1855.
  • 27. Mathew M, Das Gupta V, Bethea C (1993) Quantitation of flurbiprofen in tablets using high performance liquid chromatography. Drug Develop Industrial Pharm 19:493-498.
Toplam 27 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Eczacılık ve İlaç Bilimleri
Bölüm Research Articles
Yazarlar

Bilal Yılmaz 0000-0002-8574-7570

Burak Bayrak 0000-0001-6550-6916

Yücel Kadıoğlu 0000-0001-6590-7306

Yayımlanma Tarihi 6 Temmuz 2022
Yayımlandığı Sayı Yıl 2022 Cilt: 2 Sayı: 3

Kaynak Göster

EndNote Yılmaz B, Bayrak B, Kadıoğlu Y (01 Temmuz 2022) Development and Validation of HPLC Method for the Determination of Flurbiprofen in Pharmaceutical Preparations. International Journal of PharmATA 2 3 72–81.