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According to World Health Organization (WHO) 10% of the medicines in the Low and Middle Income Countries (LMICs) are of poor quality posing a major public health threat. One way to circumvent such problem is the development and deployment of rapid, economical and efficient analytical methods. Hence this research aims to develop a High-Performance Thin Layer Chromatography (HPTLC) method for the determination of doxycycline hyclate. A rapid and simple HPTLC method with densitometry detection at 360 nm to determine doxycycline hyclate in capsules and tablet formulations was developed and validated. HPTLC was performed on glass plates coated with C18 reverse phase silica gel 60 F₂₅₄ and pretreated with 0.27 M ethylenediaminetetraaceticacid (EDTA) solution. The mobile phase was dichloromethane: methanol: acetonitrile: 1% aqueous ammonia in the ratio of 10:22:53:15 (v/v). The linearity range lies between 200 and 1,000 ng/spot with correlation coefficient of 0.997. The Rf value is 0.5 ± 0.02%. Recoveries were in the range of 94.50–100.5%. Limit of detection and limit of quantitation values for doxycycline hyclate were 40 and 160 ng/spot respectively. The developer method was validated as per ICH guidelines. Thus, it was found to be accurate, precise, specific and robust. In forced degradation study, doxycycline hyclate was found to degrade in acidic and alkaline media, and through oxidative stress. The drug was found to be relatively stable to heat and photo degradation. The method was successfully applied for the routine quantitative analysis of dosage forms containing doxycycline hyclate. The developed method offered comparable results (as confirmed by F-test) with that of the HPLC pharmacopoeial (BP) analysis method.
Czasopismo
Rocznik
Tom
Strony
287--295
Opis fizyczny
Bibliogr. 25 poz., rys., wykr.
Twórcy
autor
- Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, Addis Ababa University, P.O. Box 1176, Addis Ababa, Ethiopia
- Pharmacure Pharmaceutical Manufacturing and Suppliers PLC, P.O. Box 5542, Addis Ababa, Ethiopia
autor
- FHI 360, Product Quality and Compliance, Durham, NC, USA
autor
- Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, Addis Ababa University, P.O. Box 1176, Addis Ababa, Ethiopia
autor
- Department of Pharmaceutical Chemistry and Pharmacognosy, School of Pharmacy, Addis Ababa University, P.O. Box 1176, Addis Ababa, Ethiopia
Bibliografia
- 1. Fiori, J.; Grassigli, G.; Filippi, P.; Gotti, R.; Cavrini, V. HPLC-DAD and LC-ESI-MS analysis of doxycycline and related impurities in doxipan mix, a medicated premix for incorporation in medicated feedstuff. J. Pharm. Biomed. Anal. 2004, 37, 979–85.
- 2. Martindale. The Complete Drug Reference, 36th ed.; Pharmaceutical Press: London, 2009, pp 257–659.
- 3. Quarterman, M. J.; Johnson, D. W.; Abele, D. C.; Lesher, J. L.; Hull, D. S.; Davis, L. S. Ocular rosacea signs, symptoms, and tear studies
- before and after treatment with doxycycline. Arch. Dermatol. 1997, 133, 49–54.
- 4. Ramesh, P. J.; Basavaiah, K.; Tharpa, K.; Vinay, K. B.; Revanasiddappa, H. D. Development and validation of RP-HPLC metod for the determination of doxycycline hyclate in spiked human urine
- and pharmaceuticals. JPCCR 2010, 4, 101–7.
- 5. British Pharmacopoeia (BP), Ed. London, the United Kingdom: The British Pharmacopoeia Secretariat, 2014.
- 6. European Pharmacopoeia (Ph.Eur.). European Directorate for the Quality of Medicines, Council of Europe, 5th ed.: Strasbourg, France, 2005, pp 1898–9.
- 7. United States Pharmacopeia the National Formulary (USP 32/NF 27), edition. The United States Pharmacopeial Convention, Inc: Rockville, MD; p 2731.
- 8. World Health Organization. The International Pharmacopoeia, 4th ed.; 2008. Retrieved from http://apps.who.int/phint/en/p/about/ (Accessed on April 4, 2017).
- 9. World Health Organization Essential Medicines List (EML), 19th ed.; 2015, pp 1–50.
- 10. Jantratid, E.; Strauch, S.; Becker, C.; Dressman, J. B.; Amidon, G. L.; Junginger, H. E.; Kopp, S.; Midha, K. K.; Shah, V. P.; Stavchansky, S.; Barends, B. M. Biowaiver monographs for immediate release solid oral dosage forms: doxycycline hyclate. J. Pharm. Sci. 2010, 99, 1350–60.
- 11. Andola, H. C.; Purohit, V. K. High performance thin layer chromatography: a modern analytical tool for biological analysis. Nat. Sci. 2010, 8, 58–61.
- 12. Ramu, B.; Kishore, B. C. HPTLC and its role in pharmaceutical industry. Open Sci. J. Biosci. Bioeng. 2018, 5, 29–34.
- 13. Bhole, R. P.; Shinde, S. S.; Chitlange, S. S.; Wankhede, S. B. High-performance thin layer chromatographic method for simultaneous determination of diphenhydraminehydrochloride and naproxen sodium in tablets. Anal. Chem. Insights 2015, 10, 47–51.
- 14. More, S.; Tamboli, A.; Amol, V.; Patil, S. HPTLC method development for simultaneous determination of Pregabalin and Amitriptyline Hydrochloride in pharmaceutical dosage forms. JDDT 2019, 9, 348–54.
- 15. Choma, I.; Grendaa, D.; Malinowskab, I.; Suprynowicza, Z. Determination offlumequine and doxycycline in milk by a simple thin-layer chromatographic method. J. Chrom. B 1999, 734, 7–14.
- 16. Mohammad, M. A. A.; Zawilla, N. H. Thin-layer and column-chromatographic methods for simultaneous analysis of ambroxol hydrochloride and doxycycline hyclate in a binary mixture. JPC-J Planar Chromat 2009, 22, 201–6. https://doi.org/10.1556/JPC.22. 2009.3.8.
- 17. Liang, Y.; Simon, R.; Bonner Denton, M. Utilization of a scientifically operated charge-coupled device detector for high-performance thin-layer chromatographic analysis of tetracyclines. Analyst 1999, 124(11), 1577–82.
- 18. Kogawa, A. C.; De Mello, N. P.; Salgado, H. R. N. Quantification of doxycycline in rawmaterial by an eco-friendly method of infrared spectroscopy. Pharma Anal Acta 2016, 7, 1–4.
- 19. Cars, O.; Ryan, D. M. Concentration of doxycycline in muscle tissues and muscle tissue fluids. Scand. J. Infect. Dis. 1988, 53, 18–21.
- 20. ICH Q2(R1). Harmonized Tripartite Guideline. Validation of Analytical Procedures: Text and Methodology, Geneva, 2005. Retrieved from http://www.ich.org (Accessed on April 6, 2017).
- 21. Becic, E.; Imamovic, B.; Dedic, M.; Sober, M. S. P. E. Extraction and TLC identification tetracycline and fluoroquinolone in surface water. Bull. Chemists Technologists Bosnia Herzegovina 2014, 43, 35–40.
- 22. Yu, H.; Mun, H.; Hu, Y. Determination of fluoroquinolones, sulfonamides, and tetracyclines multiresidues simultaneously in porcie tissue by MSPD and HPLC–DAD. J. Pharm. Anal. 2012, 2, 76–8.
- 23. Ermer, J. Validation in pharmaceutical analysis. Part I: an integrated approach. J. Pharm. Biomed. Anal. 2001, 24, 755–67.
- 24. Darwish, K. M.; Salama, I.; Mostafa, S.; El-Sadek, M. RP-HPLC/pre-column derivatization for analysis of omeprazole, tinidazole, doxycycline and clarithromycin. J. Chromatogr. Sci. 2013, 51(6), 566–76.
- 25. Kogawa, A. C.; Salgado, H. Quantification of doxycycline hycla te in tablets by HPLC-UV method. J. Chromatogr. Sci. 2012, 51, 919–25.
Typ dokumentu
Bibliografia
Identyfikator YADDA
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