İstanbul Journal of Pharmacy

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DOI :10.26650/IstanbulJPharm.2022.1005453   IUP :10.26650/IstanbulJPharm.2022.1005453    Tam Metin (PDF)

Development and validation of an RP-HPLC method for simultaneous determination of curcumin and metronidazole in combined dosage form

Leyla Beba Pozharani, Emine Vildan Burgaz, Esra Baloğlu

Background and Aims: The present study aimed to develop and validate a simple reverse phase-high pressure liquid chromatography (RP-HPLC) method for simultaneous determination of natural compound curcumin and metronidazole in bulk and its combined dosage form. Methods: In situ gel formulation containing curcumin and metronidazole was prepared as a model combined system. The chromatographic separation was accomplished isocratically on Eclipse XDB-C18 (150 mm x 4.6 mm, 5 μm particle size) column using UV-detection at 254 nm. The optimized mobile phase contained a mixture of Phosphate Buffer pH4.5-Acetonitrile (50:50, v/v), and the flow rate was set to 1.0 mL/min with 10 μL injection volume. The method was validated in compliance with International Council for Harmonisation (ICH) standards, and it was successfully used for quality control assays for their combined drug product Results: The results for retention times were 8.60 and 1.40 min for curcumin and metronidazole, respectively. The method indicated linear responses within the concentration ranges of 3.0-80 and 4.8-128 μg/mL with LOD values of 0.62; 1.03 μg/mL and LOQ values of 1.88; 3.13 μg/mL for curcumin and metronidazole, respectively. Precision results were within acceptable limits (RSD<2%), and the determination of the two active substances was not interfered with by any formulation components. Conclusion: The proposed validated RP-HPLC method was successfully applied to determine the total contents of curcumin and metronidazole in situ gel formulation. The validation results showed that the proposed method was simple, specific, and precise, and that it could be used for routine quality control for their combined pharmaceutical application.

Anahtar Kelimeler: Curcumin, Metronidazole, Simultaneous-quantification, HPLC method development

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Referanslar

  • Baloglu, E., Karavana, S. Y., Senyigit, Z. A., & Guneri, T. (2011a). Rheological and mechanical properties of poloxamer mixtures as a mucoadhesive gel base. Pharmaceutical development and technology, 16(6), 627-636. doi: 10.3109/10837450.2010.508074. google scholar
  • Baloglu, E., Karavana, S. Y., Senyigit, Z. A., Hilmioglu-Polat, S., Metin, D. Y., Zekioglu, O., ... & Jones, D. S. (2011b). In-situ gel formulations of econazole nitrate: preparation and in-vitro and in-vivo evaluation. Journal of Pharmacy and Pharmacology, 63(10), 1274-1282. doi: 10.1111/j.2042-7158.2011.01315.x. google scholar
  • Basnet, P., & Skalko-Basnet, N. (2011). Curcumin: an anti-inflammatory molecule from a curry spice on the path to cancer treatment. Molecules, 16(6), 4567-4598. doi: 10.3390/mole-cules16064567. google scholar
  • Berginc, K., Skalko-Basnet, N., Basnet, P,, & Kristl, A. (2012). Development and evaluation of an in vitro vaginal model for assessment of drug’s biopharmaceutical properties: Curcumin. AAPS PharmSciTech, 13(4), 1045-1053. doi: 10.1208/s12249-012-9837-9. google scholar
  • Çelebier, M., Kaynak, M. S., Altinoz, S., & Sahin, S. (2010). HPLC method development for the simultaneous analysis of amlodipine and valsartan in combined dosage forms and in vitro dissolution studies. Brazilian Journal of Pharmaceutical Sciences, 46, 761768. doi: 10.1590/S1984-82502010000400018. google scholar
  • Chanda, S., & Rakholiya, K. (2011). Combination therapy: Synergism between natural plant extracts and antibiotics against infectious diseases. In A. Mendez-Vilas (Ed.), Science against microbial pathogens: communicating current research and technological advances (pp. 520-529). Formatex, Spain. google scholar
  • Chaudhary, H., Kohli, K., Amin, S., Arora, S., Kumar, V., Rathee, S., & Rathee, P. (2012). Development and validation of RP-HPLC method for simultaneous estimation of diclofenac diethylamine and curcumin in transdermal gels. Journal of Liquid Chromatography & Related Technologies, 35(1), 174-187. doi: 10.1080/10826076.2011.597068. google scholar
  • Cheraghipour, K., Marzban, A., Ezatpour, B., Khanizadeh, S., & Koshki, J. (2018). Antiparasitic properties of curcumin: A review. AIMS Agriculture and Food, 3(4), 561-578. doi: 10.3934/ AGRFOOD.2018.4.561. google scholar
  • Edsman, K., Carlfors, J., & Petersson, R. (1998). Rheological evaluation of poloxamer as an in situ gel for ophthalmic use. European Journal of Pharmaceutical Sciences, 6(2), 105-112. doi: 10.1016/ S0928-0987(97)00075-4. google scholar
  • Ejim, L., Farha, M. A., Falconer, S. B., Wildenhain, J., Coombes, B. K., Tyers, M., Brown, E.D., & Wright, G. D. (2011). Combinations of antibiotics and nonantibiotic drugs enhance antimicrobial efficacy. Nature Chemical Biology, 7(6), 348-350. doi: 10.1038/nchem-bio.559. google scholar
  • Galmier, M. J., Frasey, A. M., Bastide, M., Beyssac, E., Petit, J., Aiache, J. M., & Lartigue-Mattei, C. (1998). Simple and sensitive method for determination of metronidazole in human serum by highperformance liquid chromatography. Journal of Chromatography B: Biomedical Sciences and Applications, 720(1-2), 239-243. doi: 10.1016/S0378-4347(98)00443-5. google scholar
  • Garala, K., Joshi, P., Shah, M., Ramkishan, A., & Patel, J. (2013). Formulation and evaluation of periodontal in situ gel. International journal of pharmaceutical investigation, 3(1), 29. doi: 10.4103/2230-973x.108961. google scholar
  • Giuliano, E., Paolino, D., Fresta, M., & Cosco, D. (2018). Mucosal applications of poloxamer 407-based hydrogels: An overview. Pharmaceutics, 10(3), 159. doi: 10.3390/pharmaceutics10030159. google scholar
  • Held, R. B. (1987). Rural resource management. In Cloke, P.J., & Park, C.C. London: Croom Helm, 1985. 473. google scholar
  • Ibrahim, S.A., Ismail, S., Fetih, G., Shaaban, O., Hassanein, K., & Ab-dellah, N. H. (2012). Development and characterization of thermosensitive pluronic-based metronidazole in situ gelling formulations for vaginal application. Acta pharmaceutica, 62(1), 59-70. doi: 10.2478/v10007-012-0009-y. google scholar
  • ICH. (2005). ICH Topic Q2 (R1) Validation of Analytical Procedures: Text and Methodology. International Conference on Harmonization 1994 (p.17). google scholar
  • Isacchi, B., Bergonzi, M. C., Grazioso, M., Righeschi, C., Pietretti, A., Severini, C., & Bilia, A. R. (2012). Artemisinin and artemisinin plus curcumin liposomal formulations: enhanced antimalarial efficacy against Plasmodium berghei-infected mice. European Journal of Pharmaceutics and Biopharmaceutics, 80(3), 528-534. doi: 10.1016/j.ejpb.2011.11.015. google scholar
  • Jain, A., Doppalapudi, S., Domb, A. J., & Khan, W. (2016). Tacrolimus and curcumin co-loaded liposphere gel: Synergistic combination towards management of psoriasis. Journal of Controlled Release, 243, 132-145. doi: 10.1016/j.jconrel.2016.10.004. google scholar
  • Jangle, R. D., & Thorat, B. N. (2013). Reversed-phase highperformance liquid chromatography method for analysis of curcuminoids and curcuminoid-loaded liposome formulation. Indian Journal of Pharmaceutical Sciences, 75(1), 60-66. doi: 10.4103/0250-474X.113555. google scholar
  • Jayaprakasha, G. K., Jagan Mohan Rao, L., & Sakariah, K. K. (2002). Improved HPLC method for the determination of curcumin, demethoxycurcumin, and bisdemethoxycurcumin. Journal of Agricultural and Food Chemistry, 50(13), 3668-3672. doi: 10.1021/ jf025506a. google scholar
  • Ji, L., Jiang, Y., Wen, J., Fan, G., Wu, Y., & Zhang, C. (2009). A rapid and simple HPLC method for the determination of curcumin in rat plasma: assay development, validation and application to a pharmacokinetic study of curcumin liposome. Biomedical Chromatography, 23(11), 1201-1207. doi: 10.1002/bmc.1244. google scholar
  • Lakshmi, Y. S., Kumar, P., Kishore, G., Bhaskar, C., & Kondapi, A. K. (2016). Triple combination MPT vaginal microbicide using cur-cumin and efavirenz loaded lactoferrin nanoparticles. Scientific reports, 6(1), 1-13. doi: 10.1038/srep25479. google scholar
  • Mun, S. H., Joung, D. K., Kim, Y. S., Kang, O. H., Kim, S. B., Seo, Y. S., ... & Kwon, D. Y. (2013). Synergistic antibacterial effect of curcumin against methicillin-resistant Staphylococcus aureus. Phytomedicine, 20(8-9), 714-718. doi: 10.1016/J.PHYMED.2013.02.006. google scholar
  • Rangel-Castañeda, I. A., Hernández-Hernández, J. M., Pérez-Rangel, A., González-Pozos, S., Carranza-Rosales, P., Charles-Niño, C. L., ... & Castillo-Romero, A. (2018). Amoebicidal activity of curcumin on Entamoeba histolytica trophozoites. Journal of Pharmacy and Pharmacology, 70(3), 426-433. doi: 10.1111/jphp.12867. google scholar
  • Sasidharan, N. K., Sreekala, S. R., Jacob, J., & Nambisan, B. (2014). In vitro synergistic effect of curcumin in combination with third generation cephalosporins against bacteria associated with infectious diarrhea. BioMed Research International, 2014. doi: 10.1155/2014/561456. google scholar
  • Singh, S., & Giri, S. (2013). Curcumin protects oxidative stress and DNA damage induced by metronidazole and gamma radiation in vivo. Paper presented at the: Environmental Mutagen Society of India and national conference on current perspectives on environmental mutagenesis and human health, Mumbai (India), Abstract retrieved from https://www.osti.gov/etdeweb/bib-lio/22082419 google scholar
  • Teow, S. Y., & Ali, S. A. (2015). Synergistic antibacterial activity of Curcumin with antibiotics against Staphylococcus aureus. Pakistan Journal of Pharmaceutical Sciences, 28(6), 2109-2114. google scholar
  • Topal, M., Şenel, G. U., Arslan Topal, E. I., & Öbek, E. (2015). Antibiyo-tikler ve kullanım alanları. Erciyes Üniversitesi Fen Bilimleri Enstitüsü Fen Bilimleri Dergisi, 31(3), 121-127. google scholar
  • USP, (2015). U.S. Pharmacopoeia-national formulary [USP 38 NF 33]. Rockville, Md United States Pharmacopeial Convention. volume 1. google scholar
  • Venkateshwaran, T. G., & Stewart, J. T. (1995). Determination of metronidazole in vaginal tissue by high-performance liquid chromatography using solid-phase extraction. Journal of Chromatography B: Biomedical Sciences and Applications, 672(2), 300-304. doi: 10.1016/0378-4347(95)00217-7. google scholar
  • Wachter, B., Syrowatka, M., Obwaller, A., & Walochnik, J. (2014). In vitro efficacy of curcumin on Trichomonas vaginalis. Wiener klinische Wochenschrift, 126(1), 32-36. doi: 10.1007/s00508-014-0522-8. google scholar
  • Yu, T., Malcolm, K., Woolfson, D., Jones, D. S., & Andrews, G. P. (2011). Vaginal gel drug delivery systems: understanding rheological characteristics and performance. Expert Opinion on Drug Delivery, 8(10), 1309-1322. doi: 10.1517/17425247.2011.600119. google scholar
  • Yuan, Y., Cui, Y., Zhang, L., Zhu, H. P., Guo, Y. S., Zhong, B., ... & Chen, L. (2012). Thermosensitive and mucoadhesive in situ gel based on poloxamer as new carrier for rectal administration of nimesu-lide. International Journal of Pharmaceutics, 430(1-2), 114-119. doi: 10.1016/j.ijpharm.2012.03.054. google scholar

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DIŞA AKTAR



APA

Pozharani, L.B., Burgaz, E.V., & Baloğlu, E. (2022). Development and validation of an RP-HPLC method for simultaneous determination of curcumin and metronidazole in combined dosage form. İstanbul Journal of Pharmacy, 52(3), 250-257. https://doi.org/10.26650/IstanbulJPharm.2022.1005453


AMA

Pozharani L B, Burgaz E V, Baloğlu E. Development and validation of an RP-HPLC method for simultaneous determination of curcumin and metronidazole in combined dosage form. İstanbul Journal of Pharmacy. 2022;52(3):250-257. https://doi.org/10.26650/IstanbulJPharm.2022.1005453


ABNT

Pozharani, L.B.; Burgaz, E.V.; Baloğlu, E. Development and validation of an RP-HPLC method for simultaneous determination of curcumin and metronidazole in combined dosage form. İstanbul Journal of Pharmacy, [Publisher Location], v. 52, n. 3, p. 250-257, 2022.


Chicago: Author-Date Style

Pozharani, Leyla Beba, and Emine Vildan Burgaz and Esra Baloğlu. 2022. “Development and validation of an RP-HPLC method for simultaneous determination of curcumin and metronidazole in combined dosage form.” İstanbul Journal of Pharmacy 52, no. 3: 250-257. https://doi.org/10.26650/IstanbulJPharm.2022.1005453


Chicago: Humanities Style

Pozharani, Leyla Beba, and Emine Vildan Burgaz and Esra Baloğlu. “Development and validation of an RP-HPLC method for simultaneous determination of curcumin and metronidazole in combined dosage form.” İstanbul Journal of Pharmacy 52, no. 3 (Jun. 2023): 250-257. https://doi.org/10.26650/IstanbulJPharm.2022.1005453


Harvard: Australian Style

Pozharani, LB & Burgaz, EV & Baloğlu, E 2022, 'Development and validation of an RP-HPLC method for simultaneous determination of curcumin and metronidazole in combined dosage form', İstanbul Journal of Pharmacy, vol. 52, no. 3, pp. 250-257, viewed 7 Jun. 2023, https://doi.org/10.26650/IstanbulJPharm.2022.1005453


Harvard: Author-Date Style

Pozharani, L.B. and Burgaz, E.V. and Baloğlu, E. (2022) ‘Development and validation of an RP-HPLC method for simultaneous determination of curcumin and metronidazole in combined dosage form’, İstanbul Journal of Pharmacy, 52(3), pp. 250-257. https://doi.org/10.26650/IstanbulJPharm.2022.1005453 (7 Jun. 2023).


MLA

Pozharani, Leyla Beba, and Emine Vildan Burgaz and Esra Baloğlu. “Development and validation of an RP-HPLC method for simultaneous determination of curcumin and metronidazole in combined dosage form.” İstanbul Journal of Pharmacy, vol. 52, no. 3, 2022, pp. 250-257. [Database Container], https://doi.org/10.26650/IstanbulJPharm.2022.1005453


Vancouver

Pozharani LB, Burgaz EV, Baloğlu E. Development and validation of an RP-HPLC method for simultaneous determination of curcumin and metronidazole in combined dosage form. İstanbul Journal of Pharmacy [Internet]. 7 Jun. 2023 [cited 7 Jun. 2023];52(3):250-257. Available from: https://doi.org/10.26650/IstanbulJPharm.2022.1005453 doi: 10.26650/IstanbulJPharm.2022.1005453


ISNAD

Pozharani, LeylaBeba - Burgaz, EmineVildan - Baloğlu, Esra. “Development and validation of an RP-HPLC method for simultaneous determination of curcumin and metronidazole in combined dosage form”. İstanbul Journal of Pharmacy 52/3 (Jun. 2023): 250-257. https://doi.org/10.26650/IstanbulJPharm.2022.1005453



ZAMAN ÇİZELGESİ


Gönderim07.10.2021
Kabul22.08.2022
Çevrimiçi Yayınlanma30.12.2022

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