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Development and Validation of an Hplc Method for Voriconazole Active Substance in Bulk and its Pharmaceutical Formulation

Year 2016, Volume: 20 Issue: 2, 79 - 85, 02.02.2016

Abstract

ABSTRACT

 

The aim of the present study was to develop and validate of voriconazole by using High-Performance Liquid Chromatography (HPLC). As mobile phase, mixture of acetonitrile and ultrapure water (50:50) (v/v) was used. The column was a C18 column (5µm,150x4,6mm). The eluent was monitored with UV detection at 256 nm at flow rate of 1 mL/min. The method was validated partially with respect to system suitability, linearity, limit of detection (LOD) and quantitation (LOQ), precision, accuracy and specificity, selectivity and stability. Obtained results were shown, the analytical method has good linearity, accuracy, precision, selectivity and stability. Analytical method development results indicated that the LOD was 0.02176 µg/mL; LOQ was 0.06528 µg/mL assay exhibited a linear range of 1- 30 mg/L.

References

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  • Babu GS, Raju AI. UV-Spectrophotometric Determination of Voriconazole in Bulk and Its Formulation. Center of Biotechnology, Department of Chemical Engineering, Andhra University 2007;19: 1625-1627.
  • Office of Pharmaceutical Science. The Biopharmaceutics Classification System (BCS) Guidance, , http://www.fda.gov/cder/OPS/BCS_guidance.htm
  • Yang W, Wiederhold NP, Williams RO, 3rd. Drug delivery strategies for improved azole antifungal action. Expert Opin Drug Deliv 2008; 5: 1199–1216.
  • Zhang AY, Camp WL, and Elewski BE. Advances in Topical and Systemic Antifungals. Dermatologic Clinics 2007; 25: 165-183.
  • Kumar R, Sinha VR. Preparation and optimization of voriconazole microemulsion for ocular delivery. Colloids and Surfaces B: Biointerfaces 2014; 117: 82–88.
  • Moemen D, Bedir T, Awad EA, Ellayeh A. Fungal keratitis: Rapid diagnosis using methylene blue stain. Egyptian Journal of Basic and Applied Sciences 2015; doi:10.1016/j.ejbas.2015.08.001
  • Al-Badriyeh D, Lok L, Roydhouse T, Li J, Daniell M, Fullinfaw RO, Davies GE, Stewart K, Kong DCM. 2% Voriconazole Eye Drops for the Management of Ophthalmic Fungal Keratitis. International Journal of Infectious Diseases 2008; 12: e285.
  • Ramos GP, Dias PMB, Morais CB, Fröehlich PE, Agnol MD, Zuanazzi JAS. LC Determination of Four Isoflavone Aglycones in Red Clover. Choromatographia 2008; 67: 125-129.
  • Shen J, Wang Y, Ping Q, Xiao Y, Huang X. Muchoadhesive effect of thiolated PEG stearte and its modified NLC for ocular drug delivery. Journal of Controlled Release 2009; 137: 217-223.
  • Hacıoğlu A, Çıtlak A, Karakuş S. Development and validation of an HPLC method for determination of nateglinide in drug substances. Marmara Pharmaceutical Journal 2015; 19: 103-108.
  • Guideline for Submitting Samples and Analytical Data for Methods Validation. FDA, February 1987.
  • Bhadra S, Das SC, Roy S, Arefeen S, and Rouf ASS. Development and Validation of RP-HPLC Method for Quantitative Estimation of Vinpocetine in Pure and Pharmaceutical Dosage Forms. Chromatography Research International 2011; ID 801656: 1- 7.

Development and Validation of an Hplc Method for Voriconazole Active Substance in Bulk and its pharmaceutical Formulation

Year 2016, Volume: 20 Issue: 2, 79 - 85, 02.02.2016

Abstract

References

  • REFERENCES
  • Zhoua L, Glickmanb RD, Chenb N, Sponsel WE, Graybill JR, Lam KW. Determination of voriconazole in aqueous humor by liquid chromatography–electrospray ionization-mass spectrometry. Journal of Chromatography B 2002; 776: 213–220.
  • Babu GS, Raju AI. UV-Spectrophotometric Determination of Voriconazole in Bulk and Its Formulation. Center of Biotechnology, Department of Chemical Engineering, Andhra University 2007;19: 1625-1627.
  • Office of Pharmaceutical Science. The Biopharmaceutics Classification System (BCS) Guidance, , http://www.fda.gov/cder/OPS/BCS_guidance.htm
  • Yang W, Wiederhold NP, Williams RO, 3rd. Drug delivery strategies for improved azole antifungal action. Expert Opin Drug Deliv 2008; 5: 1199–1216.
  • Zhang AY, Camp WL, and Elewski BE. Advances in Topical and Systemic Antifungals. Dermatologic Clinics 2007; 25: 165-183.
  • Kumar R, Sinha VR. Preparation and optimization of voriconazole microemulsion for ocular delivery. Colloids and Surfaces B: Biointerfaces 2014; 117: 82–88.
  • Moemen D, Bedir T, Awad EA, Ellayeh A. Fungal keratitis: Rapid diagnosis using methylene blue stain. Egyptian Journal of Basic and Applied Sciences 2015; doi:10.1016/j.ejbas.2015.08.001
  • Al-Badriyeh D, Lok L, Roydhouse T, Li J, Daniell M, Fullinfaw RO, Davies GE, Stewart K, Kong DCM. 2% Voriconazole Eye Drops for the Management of Ophthalmic Fungal Keratitis. International Journal of Infectious Diseases 2008; 12: e285.
  • Ramos GP, Dias PMB, Morais CB, Fröehlich PE, Agnol MD, Zuanazzi JAS. LC Determination of Four Isoflavone Aglycones in Red Clover. Choromatographia 2008; 67: 125-129.
  • Shen J, Wang Y, Ping Q, Xiao Y, Huang X. Muchoadhesive effect of thiolated PEG stearte and its modified NLC for ocular drug delivery. Journal of Controlled Release 2009; 137: 217-223.
  • Hacıoğlu A, Çıtlak A, Karakuş S. Development and validation of an HPLC method for determination of nateglinide in drug substances. Marmara Pharmaceutical Journal 2015; 19: 103-108.
  • Guideline for Submitting Samples and Analytical Data for Methods Validation. FDA, February 1987.
  • Bhadra S, Das SC, Roy S, Arefeen S, and Rouf ASS. Development and Validation of RP-HPLC Method for Quantitative Estimation of Vinpocetine in Pure and Pharmaceutical Dosage Forms. Chromatography Research International 2011; ID 801656: 1- 7.
There are 14 citations in total.

Details

Primary Language English
Journal Section Articles
Authors

Neslihan Üstündağ Okur

Emre Şefik Çağlar This is me

Vildan Yozgatlı This is me

Publication Date February 2, 2016
Published in Issue Year 2016 Volume: 20 Issue: 2

Cite

APA Üstündağ Okur, N., Çağlar, E. Ş., & Yozgatlı, V. (2016). Development and Validation of an Hplc Method for Voriconazole Active Substance in Bulk and its Pharmaceutical Formulation. Marmara Pharmaceutical Journal, 20(2), 79-85. https://doi.org/10.12991/mpj.20162076793
AMA Üstündağ Okur N, Çağlar EŞ, Yozgatlı V. Development and Validation of an Hplc Method for Voriconazole Active Substance in Bulk and its Pharmaceutical Formulation. Marmara Pharm J. February 2016;20(2):79-85. doi:10.12991/mpj.20162076793
Chicago Üstündağ Okur, Neslihan, Emre Şefik Çağlar, and Vildan Yozgatlı. “Development and Validation of an Hplc Method for Voriconazole Active Substance in Bulk and Its Pharmaceutical Formulation”. Marmara Pharmaceutical Journal 20, no. 2 (February 2016): 79-85. https://doi.org/10.12991/mpj.20162076793.
EndNote Üstündağ Okur N, Çağlar EŞ, Yozgatlı V (February 1, 2016) Development and Validation of an Hplc Method for Voriconazole Active Substance in Bulk and its Pharmaceutical Formulation. Marmara Pharmaceutical Journal 20 2 79–85.
IEEE N. Üstündağ Okur, E. Ş. Çağlar, and V. Yozgatlı, “Development and Validation of an Hplc Method for Voriconazole Active Substance in Bulk and its Pharmaceutical Formulation”, Marmara Pharm J, vol. 20, no. 2, pp. 79–85, 2016, doi: 10.12991/mpj.20162076793.
ISNAD Üstündağ Okur, Neslihan et al. “Development and Validation of an Hplc Method for Voriconazole Active Substance in Bulk and Its Pharmaceutical Formulation”. Marmara Pharmaceutical Journal 20/2 (February 2016), 79-85. https://doi.org/10.12991/mpj.20162076793.
JAMA Üstündağ Okur N, Çağlar EŞ, Yozgatlı V. Development and Validation of an Hplc Method for Voriconazole Active Substance in Bulk and its Pharmaceutical Formulation. Marmara Pharm J. 2016;20:79–85.
MLA Üstündağ Okur, Neslihan et al. “Development and Validation of an Hplc Method for Voriconazole Active Substance in Bulk and Its Pharmaceutical Formulation”. Marmara Pharmaceutical Journal, vol. 20, no. 2, 2016, pp. 79-85, doi:10.12991/mpj.20162076793.
Vancouver Üstündağ Okur N, Çağlar EŞ, Yozgatlı V. Development and Validation of an Hplc Method for Voriconazole Active Substance in Bulk and its Pharmaceutical Formulation. Marmara Pharm J. 2016;20(2):79-85.