Validation of the method for hydrochlorothiazide assay in extemporaneous preparations

D. Alfred Ugbenbo, O. A. Zdoryk, N. Yu. Bevz, V. A. Georgiyants

Abstract


Extemporaneous preparations that contain hydrochlorothiazide are widely prescribed and used in different countries for treating adults and children. The feature of the preparation of such dosage forms is the use of substances and commercial drugs as a source of the active pharmaceutical ingredient.
Aim. To validate the UV-spectroscopic assay method for determining hydrochlorothiazide in extemporaneous syrups and powders.
Results and discussion. For method proposed the conditions of analysis, sample preparation and validation characteristics were determined. The samples of syrups and the powder were dissolved in 0.01 M sodium hydroxide solution and assessed by spectrophotometry in the ultraviolet region of light at the wavelength of 273 nm. The samples comply with the Beer-Lambert Bouguer law within the concentration range of 8 × 10-3-1.2 × 10-2 mg/ml with the the correlation coefficients ≥ 0.9992. The uncertainty of the methods was within the critical value of the error (the powder – 1.14 %, the syrup – 0.72 %) for both samples of the syrup containing the pure substance and commercial tablets. The assay method of hydrochlorothiazide in the extemporaneous preparations meets the acceptance criteria for the assay limits of ± 7.5 % and ± 10 % by such validation parameters as specificity, linearity, precision, accuracy within the range of 80-120 % of the nominal content.                                 Experimental part. For research the volumetric glassware Class A, an UV-spectrophotometer (Thermoscientific Evolution 60S), analytical balances (AXIS ALN220), reagents and solvents corresponding to the requirements of the State Pharmacopoeia of Ukraine were used.                                               Conclusions. The validation results have proven that the method can be reproduced correctly and is suitable for use in pharmaceutical analysis.


Keywords


Hydrochlorothiazide; UV-spectrophotometry; validation of the analytical method; extemporaneous preparations

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References


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GOST Style Citations


1. allen, L. V., Erickson, M. A. (1996). Stability of labetalol hydrochloride, metoprolol tartrate, verapamil hydrochloride, and spironolactone with
hydrochlorothiazide in extemporaneously compounded oral liquids. American Journal of Health–System Pharmacy, 53 (19), 2304–2309.

2. Sickkids pharmacy: hydrochlorothiazide oral suspension. (2016). Available at: http://www.sickkids.ca/pdfs/.

3. Pepid’s AHFS Drug Information: Cardiovascular drugs. Pepid’s AHFS Drug Information. (2016). Available at: https://www.pepidonline.com/Main.aspx.

4. Budavari, S. (2001). The merck index: An encyclopedia of chemicals, drugs and biological. Merck Research Laboratories, Whitehouse Station. New
Jersey: Merck and Co. Inc., 853–855.

5. Sweetman, S. C. (2002). Martindale: The complete drug reference. London: The Pharmaceutical Press London, 907–908.

6. Musko, M., Sznitowska, M. (2014). Use of compounded dispersing media for extemporaneous pediatric syrups with candesartan cilexetil and
valsartan. Acta Pharmaceutica, 64 (4), 463–474. doi : 10.2478/acph–2014–0037.

7. Ansel, H. C., Allen, L. V., Popovich, N. G. (2011). Ansel’s Pharmaceutical Dosage Forms and Drug Delivery Systems. Philadephia, 345–360.

8. Alfred–Ugbenbo, D., Zdoryk, O. A., Georgiyants, V. A., Schnatz, R. (2016). Compounding in Nigeria. IJPC, 3 (20), 189–192.

9. Dimitrovska, M. T., Trombeva, D. (2014). Introducing of compounded pediatric chloral hydrate syrup–drug deficiency solution: Proceedings of 19th
Congress of the EAHP. Barcelona, 126.

10. USP–NF Compounded preparations monographs. (2016). Available at: http://www.usp.org/.

11. Emergency compounding: preparation of oral suspension from 75 mg tamiflu Capsules. (2016). Genentech. Available at: http://www.tamiflu.com/.

12. Pokharkar, V. B., Mandpe, L. P., Padamwar, M. N., Ambike, A. A., Mahadik, K. R., Paradkar, A. (2006). Development, characterization and stabilization
of amorphous form of a low Tg drug. Powder Technology, 167 (1), 20–25. doi: 10.1016/j.powtec.2006.05.012.

13. Allen, L. V. (1997). A formulation for preparing Syrup NF. IJPC, 2 (1), 111.

14. State Pharmacopoeia of Ukraine. (2015). Kharkiv: State Enterprise Ukrainian Scientific Center pharmacopoeia quality medicines, 1128.

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16. Gryzodub, A. I. (2016). Process validation of standardized quality control procedures for medicines. Kharkiv: State Enterprise Ukrainian Scientific
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17. European pharmacopoeia. (2011). Strasbourg: Council of Europe, 40–41, 2193–2194.





DOI: https://doi.org/10.24959/ophcj.17.915

Abbreviated key title: Ž. org. farm. hìm.

ISSN 2518-1548 (Online), ISSN 2308-8303 (Print)