VALIDATED SPECTROFLUORIMETRIC METHOD FOR THE DETERMINATION OF DORZOLAMIDE HYDROCHLORIDE IN ITS PURE FORM AND PHARMACEUTICAL FORMULATIONS VIA DERIVATIZATION WITH 4-CHLORO-7-NITROBENZO-2-OXA-1, 3-DIAZOLE (NBD-CL)

Authors

  • Ahmed Ali Almrasy

Abstract

Objectives: An accurate and precise spectrofluorimetric method was developed and validated for the determination of dorzolamide hydrochloride in its pure form and pharmaceutical formulations. Method: Based on nucleophilic substitution reaction of target drug with 4-chloro-7-nitrobenzo-2-oxa-1, 3-diazole (NBD-Cl) to form a highly fluorescent fluorophore measured at 541 nm after excitation at 404 nm. Results: Under optimum condition, the proposed method obeys Beer’s law in range (1- 8 µg/mL) and the reaction mechanisms were presented. Conclusion: The method was validated according to ICH guideline for accuracy, precision and was successfully applied for the determination of the drug in its pure form and pharmaceutical formulations. The obtained results were statistically compared with those of the reported method and found to be in good agreement.

References

Martindale, (2002). The Complete Drug Reference (33rd Ed.), Pharmaceutical Press.

Nagalakshmi, S., Damodharan, N., Thanka, J., Seethalakshmi, S. (2016). Development and Estimation of Dorzolamide Hydrochloride by Different Spectroscopic Methods. Jcps. 9(4): 3045-3049.

Sharath, H. M., Jose, G. B., Channabasavaraj, K. P., Modiya, J. S. (2011). Development and validation of spectrophotometric methods for estimation of dorzolamide HCl in bulk and pharmaceutical dosage forms. International Journal of Pharmaceutical Sciences and Research, 2(4): 948-953.

Dias, A. N., Subrahmanyam, E. V. S., Shabaraya, R., Misquith, J. (2013). New analytical method and its validation for the estimation of dorzolamide hydrochloride in bulk and marketed formulation. Int. J. Chem. Tech. Res. 5: 1655-1663.

Tim, R. C., Kautz, R. A., Karger, B. L. (2000). Ultratrace analysis of drugs in biological fluids using affinity probe capillary electrophoresis: analysis of dorzolamide with fluorescently labeled carbonic anhydrase. Electrophoresis. 21(1): 220-226.

Alarfaj, N. A., El-Tohamy, M. F. (2016). New electrochemically-modified carbon paste inclusion β-cyclodextrin and carbon nanotubes sensors for quantification of dorzolamide hydrochloride. Int. J. Mol. Sci. 17(12): 2027-2042.

Erk, N. (2003). Voltammetric and HPLC determination of dorzolamide hydrochloride in eye drops. Pharmazie. 58(12): 870-873.

Havele, S. S., Dhaneshwar, S. R. (2012). Stability-indicating hptlc-densitometric method for estimation of dorzolamide hydrochloride in eye drops. ISRN Analytical Chemistry. doi:10.5402/2012/414075.

Sharath, H. M., Channabasavaraj, K. P., Babu, J. G., Modiya, J. S. (2011). Stability-indicating RP-HPLC method for analysis of dorzolamide HCl in the bulk drug and it’s pharmaceutical dosage form. Int J Pharm Pharm Sci. 3(3): 100¬-105.

Zammataro, A., Saletti, R., Civiale, C., Muccilli, V., Cunsolo, V., Foti, S. (2010). Simultaneous quantification of carteolol and dorzolamide in rabbit aqueous humor and ciliary body by liquid chromatography/atmospheric pressure chemical ionization mass spectrometry. J. Chromatogr. B. 878(9-10), 807-814.

Maltese, A., Bucolo, C. (2002). Rapid high performance liquid chromatographic assay of dorzolamide in rabbit aqueous humor. Biomed. Chromatogr. 16(4): 274-276.

Novak, T. J., Berwick, L. (1998). Determination of the enantiomeric composition of a novel topically active carbonic anhydrase inhibitor by HPLC. J Liq Chromatogr Relat Technol. 21(12), 1883-1896.

Constanzer, M. L., Chavez, C. M., Matuszewski, B. K. (1997). Low level determination of dorzolamide and its de-ethylated metabolite in human plasma by liquid chromatography with atmospheric pressure chemical ionization tandem mass spectrometry. J. Pharm. Biomed. Anal. 15(7): 1001-1008.

Dovletoglou, A., Thomas, S. M., Berwick, L., Ellison, D. K., Tway, P. C. (1995). Development of practical HPLC methods for analysis and quality assessment of the novel carbonic anhydrase inhibitor MK-0507 and the acetamidosulfonamide intermediate. J Liq Chromatogr Relat Technol. 18(12), 2337-2352.

Ghosh, P.M., Whitehouse, M.W. (1968). 7-Chloro-4nitrobenzo-2-oxa-1,3-diazole: a new fluorigenic reagent for amino acids and other amines. Biochem. J. 108: 155-156.

Imai, K., Toyo'oka , T., Miyano, H. (1984). Fluorigenic reagents for primary and secondary amines and thiols in high-performance liquid chromatography. A review .Analyst. 109: 1365-1373.

Moneeb, M. S. (2013). Spectrophotometric and spectrofluorimetric methods for the determination of saxagliptin and vildagliptin in bulk and pharmaceutical preparations. Bulletin of Faculty of Pharmacy, Cairo University. 51 (2): 139–150.

Attia, K., Magdy, N., Mohamed, G. (2017). Validated spectrofluorimetric method for the determination of cefoxitin sodium in its pure form and powder for injection via derivatization with 4-chloro-7-nitrobenzo-2-oxa-1, 3-diazole (NBD-CL). JAPR. 1(4): 209-215.

Miyano, H., Toyo’oka, T., Imai, K. (1985). Further studies on the reaction of amines and proteins with 4-fluoro7-nitrobenzo-2-oxa-1, 3-diazole. Anal. Chim. Acta. 170: 81–87.

ICH Harmonized Tripartite Guidelines, Q2 (R1) Validation of Analytical Procedures: Text and Methodology. 2005.

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Published

2018-06-06

How to Cite

Almrasy, A. A. (2018). VALIDATED SPECTROFLUORIMETRIC METHOD FOR THE DETERMINATION OF DORZOLAMIDE HYDROCHLORIDE IN ITS PURE FORM AND PHARMACEUTICAL FORMULATIONS VIA DERIVATIZATION WITH 4-CHLORO-7-NITROBENZO-2-OXA-1, 3-DIAZOLE (NBD-CL). Innoriginal: International Journal of Sciences, 17–20. Retrieved from https://innoriginal.com/index.php/iijs/article/view/161

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RESEARCH ARTICLE