Development and Validation of Extractive Spectrophotometric Method for Estimation of Hydroxychloroquine Sulphate by using Smartphone Application
Abstract
A simple, sensitive, accurate, precise and reproducible extractive spectrophotometric method was developed for estimation of Hydroxychloroquine Sulphate (HCQS) in bulk and pharmaceutical dosage form. The method is based on formation of ion pair complex of Hydroxychloroquine Sulphate with Bromocresol green dye in acidic medium. This complex extracted in chloroform and measured quantitatively at 421nm for estimation of Hydroxychloroquine Sulphate present in the sample. In this method estimation was also done by using Smartphone Application known as PhotoMetrix pro. Beer Lambert’s law obeyed over a range of 2-10 μg/ml for HCQS by UV spectrophotometric (r²=0.9988) and by SmartPhone Image analysis (r²=0.999) method. The developed method was successfully applied for estimation of Hydroxychloroquine Sulphate in three commercial product tablet dosage form without interference from common additives. The assay was found to be 100.09%, 100.8%, 98.6% by UV and 99.2%, 101.46%, 101.1% using PhotoMetrix for three formulation containing Hydroxychloroquine Sulphate. The developed method was also validated according to ICH Q2 guideline for linearity, range, accuracy, and precision. Comparison for both method UV and PhotoMetrix done by performing t-test, result shows that there is no significant difference between both method so PhotoMetrix can be used as alternative to UV for routine analysis of Hydroxychloroquine Sulphate.
Keywords: Hydroxychloroquine Sulphate, Bromocresol green, Potassium Hydrogen Phthalate buffer, UV spectrophotometric, PhotoMetrix.
Keywords:
Hydroxychloroquine Sulphate, Bromocresol green, Potassium Hydrogen Phthalate buffer, UV spectrophotometric, PhotoMetrixDOI
https://doi.org/10.22270/jddt.v12i3.5460References
Bilgin ZD, Evcil I, Yazgi D, Binay G, Okuyucu Genc C, Gulsen B, et al. Liquid Chromatographic Methods for COVID-19 Drugs, Hydroxychloroquine and Chloroquine. Journal of Chromatographic Science. 2021 Aug 18; 59(8):748-57. https://doi.org/10.1093/chromsci/bmaa110
Hydroxychloroquine sulfate | C18H28ClN3O5S - PubChem [Internet]. [cited 2022 Apr 12]. Available from: https://pubchem.ncbi.nlm.nih.gov/compound/Hydroxychloroquine-sulfate
Mechanism of action of hydroxychloroquine as an antirheumatic drug. | DrugBank Online [Internet]. [cited 2022 Apr 12]. Available from: https://go.drugbank.com/articles/A183074
Liu J, Cao R, Xu M, Wang X, Zhang H, Hu H, et al. Hydroxychloroquine, a less toxic derivative of chloroquine, is effective in inhibiting SARS-CoV-2 infection in vitro. Cell Discovery. 2020 Dec 18; 6(1):16. https://doi.org/10.1038/s41421-020-0156-0
Pokharana M, Vaishnav R, Goyal A, Shrivastava A, Stability testing guidelines of pharmaceutical products, Journal of Drug Delivery and Therapeutics 2018; 8(2):69-175. https://doi.org/10.22270/jddt.v8i2.1564
Park JY, Song HH, Kwon YE, Kim SJ, Jang S, Joo SS. Development and validation of LC-MS/MS for bioanalysis of hydroxychloroquine in human whole blood. Journal of Biomedical Translational Research. 2018 Dec; 19(4):130-9. https://doi.org/10.12729/jbtr.2018.19.4.130
Singh A, Roopkishora, Singh CL, Gupta R, Kumar S, Kumar M. Development and Validation of Reversed-Phase High Performance Liquid Chromatographic Method for Hydroxychloroquine Sulphate. Indian J Pharm Sci. 2015; 77(5):586-91. https://doi.org/10.4103/0250-474X.169038
Qu Y, Noe G, Breaud AR, Vidal M, Clarke WA, Zahr N, et al. Development and validation of a clinical HPLC method for the quantification of hydroxychloroquine and its metabolites in whole blood. Future Science OA. 2015 Nov; 1(3). https://doi.org/10.4155/fso.15.24
Dongala T, Katari NK, Palakurthi AK, Katakam LNR, Marisetti VM. Stability Indicating LC Method Development for Hydroxychloroquine Sulfate Impurities as Available for Treatment of COVID-19 and Evaluation of Risk Assessment Prior to Method Validation by Quality by Design Approach. Chromatographia. 2020 Oct 25; 83(10):1269-81. https://doi.org/10.1007/s10337-020-03945-5
Füzéry AK, Breaud AR, Emezienna N, Schools S, Clarke WA. A rapid and reliable method for the quantitation of hydroxychloroquine in serum using turbulent flow liquid chromatography-tandem mass spectrometry. Clinica Chimica Acta. 2013 Jun; 421:79-84. https://doi.org/10.1016/j.cca.2013.02.018
Williams SB, Patchen LC, Churchill FC. Analysis of blood and urine samples for hydroxychloroquine and three major metabolites by high-performance liquid chromatography with fluorescence detection. Journal of Chromatography B: Biomedical Sciences and Applications. 1988; 433:197-206. https://doi.org/10.1016/S0378-4347(00)80598-8
Noé G, Amoura Z, Combarel D, Lori L, Tissot N, Seycha A, et al. Development and Validation of a Fast Ultra-High Performance Liquid Chromatography-Fluorescent Method for the Quantification of Hydroxychloroquine and Its Metabolites in Patients With Lupus. Therapeutic Drug Monitoring. 2019 Aug; 41(4):476-82. https://doi.org/10.1097/FTD.0000000000000614
Bodur S, Erarpat S, Günkara ÖT, Bakırdere S. Accurate and sensitive determination of hydroxychloroquine sulfate used on COVID-19 patients in human urine, serum and saliva samples by GC-MS. Journal of Pharmaceutical Analysis. 2021 Jun; 11(3):278-83. https://doi.org/10.1016/j.jpha.2021.01.006
Moraes ANF, Silva LAD, de Oliveira MA, de Oliveira EM, Nascimento TL, Lima EM, et al. Compatibility study of hydroxychloroquine sulfate with pharmaceutical excipients using thermal and nonthermal techniques for the development of hard capsules. Journal of Thermal Analysis and Calorimetry. 2020 Jun 6; 140(5):2283-92. https://doi.org/10.1007/s10973-019-08953-8
Mellon MG. The Role of Spectrophotometry in Colorimetry. Industrial & Engineering Chemistry Analytical Edition. 1937 Feb 1; 9(2):51-6. https://doi.org/10.1021/ac50106a001
Indian Pharmacopoeia. Vol. 1. 2007. 304-340 p.
Rahman N, Hejaz-Azmi SN. Extractive spectrophotometric methods for determination of diltiazem HCl in pharmaceutical formulations using bromothymol blue, bromophenol blue and bromocresol green. Journal of Pharmaceutical and Biomedical Analysis. 2000 Dec; 24(1):33-41. https://doi.org/10.1016/S0731-7085(00)00409-X
Prashanth KN, Swamy N, Basavaiah K. Extractive Spectrophotometric Methods for the Determination of Zolmitriptan in Bulk Drug and Pharmaceutical Formulation Using Bromocresol Green. Journal of Applied Spectroscopy. 2013 Nov 13; 80(5):745-53. https://doi.org/10.1007/s10812-013-9836-y
Ramadan AA, Zeino S. Development and Validation of Spectrophotometric Determination of Glimepiride in Pure and Tablet Dosage forms through Ion-Pair Complex Formation using Bromothymol Blue. Research Journal of Pharmacy and Technology. 2018; 11(7):3049. https://doi.org/10.5958/0974-360X.2018.00561.9
Idris AY, Maaorb UMA. Spectrophotometric determination of Risperidone in pure and tablet dosage form by formation of a coloured ion-pair complex with bromocresol green. Nigerian Journal of Scientific Research. 2015 Jan; 1(14):41-6.
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