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Abstrakty
The objective of the current research is to understand the degradation behavior of avanafil under different stress conditions and to develop a stability-indicating high-performance liquid chromatography (HPLC) method for simultaneous determination of degradants observed during degradation. Avanafil tablets were exposed to acid, base, water, oxidative, thermal, and photolytic degradation conditions. In acid, oxidative, thermal, and humidity degradation, significant degradation was observed. All the degradants observed during degradation were separated from known impurities of avanafil by using reverse-phase (RP)-HPLC. Mobile phase A, 0.1% trifluoro acetic acid and triethylamine in water, and mobile phase B, water and acetonitrile in the ratio of 20:80 (v/v), were used at a flow rate of 1.2 mL/min in gradient elution mode. Separation was achieved by using Inertsil ODS 3 column (3 μm, 4.6 mm × 250 mm) at 45 °C. Peak responses were recorded at 245 nm. Method capability for detecting and quantifying the degradants, which can form during stability, was proved by demonstrating the peak purity of avanafil peak in all the stressed samples. Mass balance was established by performing the assay of stressed sample against reference standard. Mass balance was found >97% for all the stress conditions. The developed analytical method was validated as per International Conference on Harmonization (ICH) guidelines. The method was found specific, linear, accurate, precise, rugged, and robust.
Słowa kluczowe
Czasopismo
Rocznik
Tom
Strony
158--163
Opis fizyczny
Bibliogr. 20 poz., rys.
Twórcy
autor
- Department of Analytical Research and Development, IPDO, Dr. Reddy's Laboratories, Hyderabad-500 072, India
- Department of Chemistry, SAS, VIT University, Vellore, Tamilnadu, India
autor
- Department of Chemistry, SAS, VIT University, Vellore, Tamilnadu, India
autor
- Department of Analytical Research and Development, IPDO, Dr. Reddy's Laboratories, Hyderabad-500 072, India
autor
- Department of Analytical Research and Development, IPDO, Dr. Reddy's Laboratories, Hyderabad-500 072, India
Bibliografia
- [1] Rx List. The Internet Drug Index. Stendra: http://www.rxlist.com/stendra-drug.htm (Accessed June 30, 2016).
- [2] Kashyap, R.; Srinivasa, U. Int. J. Pharm. Technol. 2013, 5, 5811.
- [3] Fahmy, U. A.; Aljaeid, B. M. Int. J. Adv. Pharm., Biol. Chem. 2016, 5, 59.
- [4] Kashyap, R.; Srinivasa, U.; Badodaria, K. World J. Pharm. Pharm. Sci. 2014, 3, 1697.
- [5] Kashyap, R.; Srinivasa, U.; Badodaria, K. Int. J. Pharm. Technol. 2014, 6, 6418.
- [6] Patel, M. N.; Kothari, C. S. J. AOAC Int. 2016, 15, 649.
- [7] Hegazy, M.; Kessiba, A.; Abdelkawy, M.; El-Gindy, A. E. J. Liq. Chromatogr. Relat. Technol. 2015, 38, 1660.
- [8] Azimi, S.; Mistry, N. S.; Wood, M. , www.waters/webassets/cms/library/docs/720004511en.pdf (Accessed June 30, 2016).
- [9] Codevilla, C. F.; Santos Castilhos, T.; Bergold, A. M. Braz. J. Pharm. Sci. 2013, 49, 1.
- [10] Patel, A.; Nair, A.; Prajapati, P.; Jadhav, A. Int. J. Chem. Pharm. Sci. 2015, 3, 1975.
- [11] Fahmy, U. A.; Ahmed, O. A.; Hosny, K. M. AAPS PharmSciTech. 2015, 16, 53.
- [12] U.S. Pharmacopeia. 34th edn., U.S. Pharmacopeial Convention, Rockville, MD, 2010. www.uspnf.com. (Accessed June 30, 2016).
- [13] European Pharmacopeia, 8th edn., European Directorate for Quality of Medicines, France, 2010, https://www.edqm.eu/en/european-pharmacopoeia-8th-edition-1563.html, (Accessed June 30, 2016).
- [14] International Conference on Harmonization (ICH), , Q3B (R2),“Impurities in New Drug products”, 2006, http://www.ich.org/products/guidelines/quality/article/qualityguidelines.html, (Accessed June 30, 2016).
- [15] International Conference on Harmonization (ICH), , Q2 (R1) Guidelines for validation of analytical procedures: text and methodology, http://www.ich.org/products/guidelinesquality/article/qualityguidelines.html (Accessed June 30, 2016).
- [16] Vaghela, B.; Rao, S. S.; Reddy, A. M.; Venkatesh, P.; Kumar, N. Sci Pharm. 2012, 80, 295.
- [17] Vaghela, B. K.; Rao, S. S.; Reddy, P. S. Int. J. Pharm. Pharm. Sci. 2012, 4, 615.
- [18] Reddy, P. S.; Saita, S.; Vasudevmurthya, G.; Natarajana, M.; Prasada, V.; Jayapal Reddy, S J. Chem. Pharm. Res. 2012, 4, 3263.
- [19] International Conference on Harmonization (ICH), , Q1A (R2), Stability Testing of New Drug Substances and Products, 2003, Geneva. http://www.ich.org/products/guidelines/quality/article/qualityguidelines.html (Accessed June 30, 2016).
- [20] International Conference on Harmonization (ICH), , Q1B, Photostability Testing on new Drug Substances and Products, 1996, Geneva. http://www.ich.org/products/guidelines/quality/article/qualityguidelines.html (Accessed June 30, 2016).
Uwagi
PL
Opracowanie rekordu w ramach umowy 509/P-DUN/2018 ze środków MNiSW przeznaczonych na działalność upowszechniającą naukę (2018).
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-308530dc-6678-45d3-8a14-1ce09b108b1d