DEVELOPMENT OF THE SPECTROPHOTOMETRIC METHOD FOR THE DETERMINATION OF ROSUVASTATIN CALCIUM IN TABLETS FROM THE POSITION OF THE PRINCIPLES OF “GREEN” CHEMISTRY
DOI:
https://doi.org/10.11603/mcch.2410-681X.2024.i1.14601Keywords:
validation, quantification, rosuvastatin, spectrophotometry, tabletsAbstract
Introduction. The scientific literature describes enough spectrophotometric and chromatographic methods for the determination of rosuvastatin in medicines, however they have a number of disadvantages that limit their scope of application.
The aim of the study – to develop a simple, express, “green”, inexpensive UV-spectrophotometric method for the quantitative determination of rosuvastatin in tablets.
Research Methods. To perform the study, we used the pharmacopoeial standard sample of rosuvastatin calcium (Sigma-Aldrich, ≥98 %, HPLC), methanol R ((“Honeywell Riedel-de Haen™”, 99.9 %), Rosuvastatin tablets, 10 mg (two different manufacturers of medicines). The optical density in the UV region was measured in quartz cuvettes (1 cm) on a two-beam scanning spectrophotometer Shimadzu UV-1800 (Japan) using the UV-Probe 2.62 software.
Results and Discussion. The absorption spectra of methanol extraction from rosuvastatin tablets and pharmacopoeial standard sample of rosuvastatin calcium in methanol have an intensely pronounced absorption band at the wavelength of 243 nm. The linearity parameters met the requirements of SPhU in the entire range of application of the analytical method (2–10 μg/mL). The regression equation – y = 0.0434x + 0.0197, the correlation coefficient – 0.9990. The limit of detection of rosuvastatin calcium – 0.39 μg/mL, the limit of quantification – 1.18 μg/mL. The systematic error – 0.02 %. When studying the robustness of the method, it has been established that the solutions are stable for 120 minutes. The evaluation of the “greenness” of the method using the analytical eco-scale, the AGREE and GAPI methods proves that the proposed method corresponds to the principles of “green” chemistry.
Conclusions. A simple, express, “green”, cost-effective UV-spectrophotometric method for the quantitative determination of rosuvastatin calcium in tablets using methanol solvent and analytical wavelength of 243 nm has been developed. The proposed UV-spectrophotometric method for the determination of rosuvastatin calcium in tablets can be used in the routine work of laboratories for quality control of medicines with a limited budget, which do not have chromatographs.
References
Cortese, F., Gesualdo, M., Cortese, A., Carbonara S., Devito, F., Zito, A., ... & Ciccone, M.M. (2016). Rosuvastatin: Beyond the cholesterol-lowering effect. Pharmacological Research, 107, 1-18.
https://uk.wikipedia.org/wiki/Розувастатин
European Pharmacopoeia. (2023). European Pharmacopoeia (11th edn.). Retrieved from: https:.www.edqm.eu/en/european-pharmacopoeia-ph-eur-11-edition.
The United States Pharmacopeia. The National Formulary; United States Pharmacopeial Convention, Inc.: Rockville, MD, USA, 2021.
Uyar, B., Celebier, M., & Altinoz, S. (2007). Spectrophotometric determination of rosuvastatin calcium in tablets. Die Pharmazie-An International Journal of Pharmaceutical Sciences, 62(6), 411-413.
Gupta, A., Mishra, P., & Shah, K. (2009). Simple UV spectrophotometric determination of rosuvastatin calcium in pure form and in pharmaceutical formulations. Journal of Chemistry, 6, 89-92.
Krishna, M.V., & Sankar, D.G. (2007). Extractive spectrophotometric methods for the determination of rosuvastatin calcium in pure form and in pharmaceutical formulations by using safranin O and methylene blue. E-Journal of Chemistry, 4(1), 46-49.
Ramadan, A.A., Mandil, H.A.S.N.A., & Alshelhawi, N.O.O.R. (2014). Spectrophotometric determination of rosuvastatin calcium in pure form and pharmaceutical formulations by the oxidation using iodine and formation triiodide complex in acetonitrile. Int. J. Pharm. Pharm. Sci., 6(5), 579-585.
Lima, M.F., Cassella, R.J., & Pacheco, W.F. (2017). Spectrophotometric determination of rosuvastatin in pharmaceutical formulations using quinalizarin. Brazilian Journal of Pharmaceutical Sciences, 53.
Ramadan, A.A., Mandil, H.A.S.N.A., & Alsayed-Ali, R.A.F.I.F. (2015). Spectrophotometric determination of rosuvastatin in pure form and pharmaceutical formulations through ion-pair complex formation using bromocresol green. Int. J. Pharm. Pharm. Sci., 7(11), 191-198.
Prajapati, P.B., Bodiwala, K.B., Marolia, B.P., Rathod, I.S., & Shah, S.A. (2010). Development and validation of extractive spectrophotometric method for determination of rosuvastatin calcium in pharmaceutical dosage forms. J. Pharm. Res., 3(8), 2036-2038.
Sevda, R.R., Ravetkar, A.S., & Shirote, P.J. (2011). UV Spectrophotometric estimation of rosuvastatin calcium and fenofibrate in bulk drug and dosage form using simultaneous equation method. Int. J. Chem. Tech. Res, 3, 629-635.
Ambole, S.R., Shirote, P.J., & Kondawar, M.S. (2012). Simultaneous Estimation for Rosuvastatin calcium and Aspirin from Capsule Dosage Forms by First Order. Derivative Spectroscopic Method. International Journal of Chem. Tech. Research, 4(3), 966-970.
Afroz, A., Haque, T., Talukder, M.U., & Islam, S.M. (2011). Spectrophotometric estimation of rosuvastatin calcium and glimepiride in tablet dosage form. Asian Journal of Pharmaceutical Analysis, 1(4), 74-78.
Parmar, V., Solanki, H., & Prajapati, L. (2013). Derivative spectrophotometric determination of rosuvastatin calcium and fenofibrate in tablet dosage form. Inventi Rapid: Pharm Analysis & Quality Assurance, 2, 1-5.
Karunakaran, A., Subhash, V., Chinthala, R., & Muthuvijayan, J. (2011). Simultaneous estimation of rosuvastatin calcium and fenofibrate in bulk and in tablet dosage form by UV-spectrophotometry and RP-HPLC. Stamford Journal of Pharmaceutical Sciences, 4(1),
-63.
Sharma, S., Bhandari, P. (2005). Simultaneous Estimation of Rosuvastatin Calcium and Fenofibrate in Bulk and in Tablet Dosage Form by UV-Spectrophotometry and RP-HPLC. Journal of Pharmacy Research, 5, 2311-2314.
Beludari, M.I., Prakash, K.V., & Mohan, G.K. (2013). RP-HPLC method for simultaneous estimation of rosuvastatin and ezetimibe from their combination tablet dosage form. International Journal of Chemical and Analytical Science, 4(4), 205-209.
Eswarudu, M.M., Mounica, P., Venkatesh, D., & Nagalakshmi, B. (2012). Method development and validation for simultaneous estimation of rosuvastatin calcium and ezetimibe in pharmaceutical dosage form by RP-HPLC. International Research Journal of Pharmaceutical and Applied Sciences, 2(1), 24-36.
Trivedi, H.K., & Patel, M.C. (2012). Development and validation of a stability-indicating RP-UPLC method for determination of rosuvastatin and related substances in pharmaceutical dosage form. Scientia Pharmaceutica, 80(2), 393-406.
Rao, A. L., & Suneetha, D. (2010). Development and validation of RP-HPLC method for the estimation of rosuvastatin in bulk and pharmaceutical dosage form. Int. J. Chem. Sci, 8(2), 1308-1314.
Haq, N., Shakeel, F., Alanazi, F., Alshora, D.H., & Ibrahim, M.A. (2018). Development and validation of a green RP-HPLC method for the analysis of rosuvastatin: a step towards making liquid chromatography environmentally benign. Green Processing and Synthesis, 7(2), 160-169.
Mostafa, N.M., Badawey, A.M., Lamie, N.T., & Abd El-Aleem, A.E.A.B. (2014). Selective chromatographic methods for the determination of Rosuvastatin calcium in the presence of its acid degradation products. Journal of Liquid Chromatography & Related Technologies, 37(15), 2182-2196.
Kaila, H.O., Ambasana, M.A., Thakkar, R.S., Saravaia, H.T., & Shah, A.K. (2010). A new improved RP-HPLC method for assay of rosuvastatin calcium in tablets. Indian Journal of Pharmaceutical Sciences, 72(5), 592.
Kishore, C.R., & Mohan, G.K. (2017). Structural identification and estimation of Rosuvastatin calcium related impurities in Rosuvastatin calcium tablet dosage form. Analytical Chemistry Research, 12, 17-27.
Gomes, F.P., García, P.L., Porto Alves, J.M., Singh, A.K., Kedor-Hackmann, E.R.M., & Miritello Santoro, M.I.R. (2009). Development and validation of stability-indicating HPLC methods for quantitative determination of pravastatin, fluvastatin, atorvastatin, and rosuvastatin in pharmaceuticals. Analytical Letters, 42(12), 1784-1804.
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