Chromatographia

, Volume 67, Issue 7–8, pp 647–652 | Cite as

Development and Validation of a Stability-Indicating LC Method to Quantify Hydrochlorothiazide in Oral Suspension for Pediatric Use

  • Monika Piazzon Tagliari
  • Hellen Karine Stulzer
  • Fabio Seigi Murakami
  • Gislaine Kuminek
  • Bruno Valente
  • Paulo Renato Oliveira
  • Marcos Antonio Segatto Silva
Full Short Communication

Abstract

A stability-indicating reversed-phase high-performance liquid chromatography (LC) method was developed and validated for the determination of hydrochlorothiazide in an oral suspension. Isocratic chromatography was performed on a C18 column with 0.1 M sodium phosphate buffer pH 3.0/acetonitrile (70:30 v/v) as mobile phase, at a flow rate of 1.3 mL min−1, and UV detection at 254 nm. The method was linear (r 2 = 0.9998), accurate (mean recovery = 100.3%), and precise (RSD <2%). It was also validated for specificity and robustness. The method was successfully applied for the quality control analysis of a new pharmaceutical formulation of HCTZ for pediatric use.

Keywords

Column liquid chromatography Stability-indicating Validation Pediatric oral suspension Hydrochlorothiazide 

References

  1. 1.
    Michele TM, Knorr B, Vadas EB, Reiss TF (2002) J Asthma 39:391–403CrossRefGoogle Scholar
  2. 2.
    Nahata MC Pediatric (1999) Ann Pharmacother 33:247–249Google Scholar
  3. 3.
    Kayumba PC, Huyghebaert N, Cordella C, Ntawukuliryayo JD, Vervaet C (2007) Eur J Pharmaceut Biopharmaceut 66:460–465CrossRefGoogle Scholar
  4. 4.
    Freed AL, Silbering SB, Kolodsick KJ, Rossi DT, Mahjour M, Kingsmill CA (2005) Int J Pharm 304:135–144CrossRefGoogle Scholar
  5. 5.
    Litwin M, Sladowska J, Antoniewicz J, Niemirska A, Wierzbicka A, Daszkowska J, Wawer ZT, Janas R, Grenda R (2007) Am J Hypertens 20:875–882CrossRefGoogle Scholar
  6. 6.
    Moffat A, Osselton M, Widdop B (2004) In: Clarke’s Analysis of Drugs and Poisons, Pharmaceutical Press, LondonGoogle Scholar
  7. 7.
    Carter BL, Ernst ME, Cohen JD (2004) Hypertension 43:4–9CrossRefGoogle Scholar
  8. 8.
    European Pharmacopoeia (2001) 3rd edn, p 2966Google Scholar
  9. 9.
    The United States Pharmacopoeia (2007) 30 Revision. United States Pharmacopeial Convention, Rockeville, p 2288Google Scholar
  10. 10.
    Carlucci G, Palumbo G, Mazzeo P, Quaglia MG (2000) J Pharm Biomed Anal 23:185–189CrossRefGoogle Scholar
  11. 11.
    Erk N (1999) J Pharm Biomed Anal 20:155–167CrossRefGoogle Scholar
  12. 12.
    Dinç E, Özdemir A (2005) Il Farmaco 60:591–597CrossRefGoogle Scholar
  13. 13.
    El-Gindy A, Ashour A, Abdel-Fattah L, Shabana MM (2001) J Pharm Biomed Anal 25:923–931CrossRefGoogle Scholar
  14. 14.
    Quaglia MG, Donati E, Carlucci G, Mazzeo, Fanali S (2002) J Pharm Biomed Anal 29:981–987Google Scholar
  15. 15.
    Thompson KC, Zhao Z, Mazakas JM, Beasley CA, Reed RA, Moser CL (2003) Am J Health Syst Pharm 60:69–74Google Scholar
  16. 16.
    Flynn JT, Daniels SR (2006) J Pediatr 149:746–54CrossRefGoogle Scholar
  17. 17.
    Trissel L (2005) In: Trissel’s stability of compounded formulations. American Pharmaceutical Association, WashingtonGoogle Scholar
  18. 18.
    Shabir GA, Lough WJ, Arain SA, Bradshaw TK (2007) J Liq Chromatogr Related Technol 30:311–333CrossRefGoogle Scholar
  19. 19.
    ICH (2005) Harmonised tripartite guideline: validation of analytical procedures: text and methodology Q2 (R1)Google Scholar
  20. 20.
    Vadera N, Subramanian G, Musmade P (2007) J Pharm Biomed Anal 43:722–726CrossRefGoogle Scholar
  21. 21.
    Lusina M, Cindric T, Tomaic J, Peko M, Pozaic L, Musulin N (2005) Int J Pharm 291:127–137CrossRefGoogle Scholar
  22. 22.
    Hertzog DL, McCafferty JF, Fang X, Tyrrell RJ, Reed RA (2002) J Pharm Biomed Anal 30:747–760CrossRefGoogle Scholar

Copyright information

© Friedr. Vieweg & Sohn Verlag/GWV Fachverlage GmbH 2008

Authors and Affiliations

  • Monika Piazzon Tagliari
    • 1
  • Hellen Karine Stulzer
    • 1
  • Fabio Seigi Murakami
    • 1
  • Gislaine Kuminek
    • 1
  • Bruno Valente
    • 1
  • Paulo Renato Oliveira
    • 1
  • Marcos Antonio Segatto Silva
    • 1
  1. 1.Centro de Ciências da Saúde, Departamento de Ciências FarmacêuticasUniversidade Federal de Santa Catarina (UFSC)FlorianópolisBrazil

Personalised recommendations