DEVELOPING AND VALIDATING A STABILITY-INDICATING UV-VIS NANODROP 2000C METHOD FOR THE SIMULTANEOUS DETERMINATION OF THE ANTI-HYPERTENSIVE DRUG HYDROCHLOROTHIAZIDE (HCTZ) IN BOTH BULK AND TABLET DOSAGE FORMS
DOI:
https://doi.org/10.25271/sjuoz.2024.12.3.1324Keywords:
UV-Vis Nanodrop 2000c, Validation, Hydrochlorothiazide, Stability Indicating, HypertensionAbstract
For the simultaneous determination of anti-hypertensive drugs Hydrochlorothiazide (HCTZ) in bulk and tablet dosage forms, a simple, specific, accurate, and precise stability-indicating UV-Vis Nanodrop 2000c method was developed and validated. The maximum absorption of Hydrochlorothiazide was revealed at 271 nm using methanol as a solvent. The validation results showed good linearity (R2 = 0.9997) within the concentration range of 10-50µg/mL. The RSD revealed an acceptable value (less than 0.6 percent) in the precision study at three levels. 1.01 and 3.3g µg/mL were found to represent the LOD and LOQ, respectively. Locally and commercial tablets are Available Drug Products. Accuracy at three levels showed good recovery, more than 99% percent. The proposed method was used to analyse the stability of local and commercial tablets. The stability of their pharmaceuticals was investigated under acidic, oxidative, thermal, alkaline, and photolytic conditions in this research. In accordance with the guidelines set by the International Council for Harmonisation (ICH), the method was effectively validated. Subsequently, the validated method was employed to analyze commercially available pharmaceutical dosage forms.
References
Ali, T.A., Mohamed, G.G., Aglan, A.A. & Heakal, F.E.T. (2016). "RP-HPLC Stability-indicating Method for Estimation of Irbesartan and Hydrochlorothiazide in Bulk and Pharmaceutical Dosage Form", Chinese Journal of Analytical Chemistry, Changchun Institute of Applied Chemistry, Chinese Academy of Sciences, Vol. 44 No. 1, pp. e1601–e1608.
Bharathi, D.V., Hotha, K.K., Chatki, P.K., Satyanarayana, V. & Venkateswarlu, V. (2012). "LC-MS/MS method for simultaneousestimationofcandesartanandhydrochlorothiazide in human plasma and its use in clinical pharmacokinetics", Bioanalysis, Vol. 4 No. 10, pp. 1195–1204.
Chakraborty, A., Jayaseelan, K., Rathinam, S., Kokilambigai, K.S. & Nethra, K. (2024). "Bioanalytical methods and extraction techniques for the quantification of hydrochlorothiazideanditspharmaceutical combinations:Acomprehensivereview",Acta Chromatographica,No.0,available at:https://doi.org/10.1556/1326.2023.01187.
Devi, D.A. & Bhavani, P.G. (2023). "Development and validation of stability indicating UPLC method for the simultaneous estimation of triamterene and hydrochlorothiazide in combined dosage forms using quality by design approach", Future Journal of Pharmaceutical Sciences, Springer Berlin Heidelberg, Vol.9No. 1, available at:https://doi.org/10.1186/s43094-022-00438-0.
Hemke, A.T., Bhure, M. V., Chouhan, K.S., Gupta, K.R. and Wadodkar, S.G. (2010), “UV spectrophotometric determination of hydrochlorothiazide and olmesartan medoxomil in pharmaceutical formulation”, E-Journal of Chemistry, Vol. 7 No. 4, pp. 1156–1161.
Kaushik D, A.P. (2013). "UPLC Method for Simultaneous Determination of Valsartan & Hydrochlorothiazide in Drug Products", Journal of Chromatography & Separation Techniques, Vol. 04 No. 05, available at:https://doi.org/10.4172/2157-7064.1000182.
Lahsini, R. and Monser, L. (2015). "Development of a new UPLC method for simultaneous determination of valsartan, amlodipine besylate, and hydrochlorothiazide pharmaceutical products", Acta Chromatographica, Vol. 27 No. 3, pp. 449–460.
Medoxomil, O. (2020). "Development and Validation of Rp-Hplc Method for Simultaneous Determination of a Combined Formulation of Development and Validation of Rp ‒ Hplc Method for Simultaneous Determination of a Combined Formulation of Olmesartan Medoxomil&",No.June,availableat:https://doi.org/10.20959/wjpps20206-16468.
Menon, S.K., Panchal, J.G. & Patel, R. V. (2009). "Development and validation of a stability indicating LC method for the determination of faropenem in pharmaceutical formulations", Chromatographia, Vol. 69 No. 9–10, pp. 1013–1018.
Mohammed, N.S. & Mohammed, A.J. (2016). "Development and Validation of RP-HPLC Method for the Determination of Hydrochlorothiazide in Bulk Drug and Pharmaceutical Dosage Form", Chromatography Research International, Vol. 2016, pp. 1–7.
Oliveira, C.V. De, Peron, A., Rashid, A., Alonso, F., Fajardo, G., Lourenço, F.R., Franco, M., et al. (2024). "Validation , measurement uncertainty estimation and evaluation of UHPLC greenness for simultaneous determination of metoprolol tartrate and hydrochlorothiazide in binary tablet", available at:https://doi.org/10.1080/16583655.2024.2339010.
Ongas, M.O., Kokwaro, G., Oloo, F., Kirimi, C.K., Mkonje, A., Otieno, F., Muasya, C., et al. (2018), “LC–MS/MS Method for Quantitation of Hydrochlorothia-zide and Nifedipine in Human Plasma”, ABC Research Alert, Vol. 6 No. 3, p. Kenya.
Patel, R.B. and Patel, M.R. (2022). "a Novel Validated Stability Indicating Analytical Hptlc Method for Quantitation of Hydrochlorothiazide and Lisinopril in Tablet Formulation", Indian Drugs, Vol. 59 No. 6, pp. 47–51.
Patel, U.M., Chokshi, A.B. and Desai, P.R. (2014), “Development and validation of RP-HPLC method for determination of hydrochlorothiazide, Olmesartan medoxomil and their related substances in combined tablet dosage form”, International Journal of Pharmacy and Pharmaceutical Sciences, Vol. 6 No. 9, pp. 318–323.
Proti, A., Jasmina, Š., Krmar, J. and Ze, M. (2017), “Multicriteria Optimization Methodology in Stability-Indicating Method Development of Cilazapril and Hydrochlorothiazide”, Vol. 55 No. 6, pp. 625–637.
Qasim, F.O. and Mohammed, N.M.S. (2021), “A Nanodrop Spectrophotometric Method and Stability Indicating for DeterminationofAmlodipine Besylate in Pharmaceutical Formulations of Kurdistan of Iraq”, Science Journal of University of Zakho, Vol. 9 No. 1, pp. 25–29.
Rane, V.P., Patil, K.R., Sangshetti, J.N., Yeole, R.D. and Shinde, D.B. (2010), “Stability Indicating LC Method for Simultaneous Determination of Irbesartan and Hydrochlorothiazide in Pharmaceutical Preparations”, Vol. 48 No. August, pp. 595–600.
Real, F.J., Acero, J.L., Benitez, F.J., Roldán, G. and Fernández, L.C. (2010), “Oxidation of hydrochlorothiazide by UV radiation, hydroxyl radicals and ozone: Kinetics and elimination from water systems”, Chemical Engineering Journal, Vol. 160 No. 1, pp. 72–78.
Sayyed, Z.M., Shinde, S.A., Chaware, V.J., Chaudhari, B.P., Biyani, K.R., Zuber, M. and Sayyed, M. (2015), “DevelopmentandValidation of UV-Spectrophotometric Method for Simultaneous Estimation of Amlodipine Besylate and Hydrochlorothiazide in Combined Dosage Form Including Stability Study”, J Pharm Sci Bioscientific Res. 2015, Vol. 5 No. 5, pp. 487–493.
Tsvetkova, D.D., Obreshkova, D.P., Petkova, V.B., Pankova, S.A., Atanasov, P.J. and Kasnakova, P.S. (2015), “Simultaneousdeterminationofvalsartanand hydrochlorothiazideintabletsbythin-layer chromatography- densitometric method.”, World JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES, Vol. 4 No. 4, pp. 1–11.
Vidyadhara, S., Sasidhar, R.L.C., Rao, B.V., Tejaswi, K. and Reshma, M. (2014), “Method development and validation for simultaneous estimation of olmesartan medoxomil and hydrochlorothiazide by RP-HPLC”, Oriental Journal of Chemistry, Vol. 30 No. 1, pp. 195–201.
Roberts, B. H. (2008). Treating and Beating Heart Disease: A Consumer's Guide to Cardiac Medicines: A Consumer's Guide to Cardiac Medicines. Jones & Bartlett Learning.
Published
How to Cite
Issue
Section
License
Copyright (c) 2024 Faroq O. Qasim, Mohammed A. Hami , Nzar I. Yousif
![Creative Commons License](http://i.creativecommons.org/l/by/4.0/88x31.png)
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License [CC BY-NC-SA 4.0] that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work, with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online.