Skip to content
2000
  1. Home
  2. A-Z Publications
  3. Current Pharmaceutical Analysis
  4. Volume 20, Issue 5
  5. Article
Volume 20, Issue 5
  • ISSN: 1573-4129
  • E-ISSN: 1875-676X

Abstract

Introduction

In this study, a new, simple, selective, and fast liquid chromatographic method has been developed and validated for the determination of imidazolidinyl urea used as an anti-microbial agent in topical formulation.

Methods

The developed HPLC method using a diode array detector for the determination of imidazolidinyl urea was applied to the topical formulation. Imidazolidinyl urea in the sample was analyzed in the cyano column (250 x 4,6 mm, 5 µm i.d.) under chromatographic conditions, where the flow rate was determined as 1.0 mL/min. The column oven was 40.0°C, and imidazolidinyl urea was detected at 210 nm. Isocratic application of acetonitrile-water (25:75, v/v) was used as the mobile phase system. The validation of the developed method was performed according to the International Conference on Harmonisation guidelines Q2 (R1).

Results

The linearity range of the imidazolidinyl urea was 0.050-0.150 mg/mL, and the limits of detection and quantification were calculated to be 62.5x10-6 mg/mL and 125x10-6 mg/mL, respectively. Assay recovery and precision of imidazolidinyl urea from topical formulation at 0.050, 0.100, and 0.125 mg/mL concentrations were evaluated. The mean recoveries for imidazolidinyl urea in the topical formulation were calculated as 98.857-104.560%.

Conclusion

The validated method was successfully applied to the determination of imidazolidinyl urea in a topical formulation. The proposed method is reproducible and reliable and can be used safely for routine analysis.

© 2024 Bentham Science Publishers
Loading

Article metrics loading...

/content/journals/cpa/10.2174/0115734129293343240604061830
2024-06-01
2025-01-10

  • From This Site

    /content/journals/cpa/10.2174/0115734129293343240604061830
    dcterms_title,dcterms_subject,pub_keyword
    -contentType:Contributor -contentType:Concept -contentType:Institution
    10
    5
Loading full text...

Full text loading...

References

  1. Birteksöz TanA.S. TüysüzM. The use of preservatives in cosmetic products and their efficiency testing.Ankem Dergisi2013272839110.5222/ankem.2013.083
     [Google Scholar]
  2. De GrootA.C. VeenstraM. Formaldehyde-releasers in cosmetics in the USA and in Europe.Contact Dermat.201062422122410.1111/j.1600‑0536.2009.01623.x20236159
     [Google Scholar]
  3. DraelosZ.D. Facial skin care products and cosmetics.Clin. Dermatol.201432680981210.1016/j.clindermatol.2014.02.02025441474
     [Google Scholar]
  4. WarshawE.M. BuchholzH.J. BelsitoD.V. MaibachH.I. FowlerJ.F.Jr RietschelR.L. ZugK.A. MathiasC.G.T. PrattM.D. SassevilleD. StorrsF.J. TaylorJ.S. DeLeoV.A. MarksJ.G.Jr Allergic patch test reactions associated with cosmetics: Retrospective analysis of cross-sectional data from the North American Contact Dermatitis Group, 2001-2004.J. Am. Acad. Dermatol.2009601233810.1016/j.jaad.2008.07.05618992965
     [Google Scholar]
  5. MichalakisG.M. BarryE.F. Determination of imidurea in cosmetic products by capillary zone electrophoresis and miscellar electrokinetic chromatography.J. Soc. Cosmet. Chem.1994199445194202
     [Google Scholar]
  6. BaalbakiB. BlanchinM.D. FabreH. Validation of a micellar electrokinetic capillary chromatography method for the determination of imidurea, methyl and propylparabens in a pharmaceutical ointment.Anal. Chim. Acta20024631152010.1016/S0003‑2670(02)00375‑6
     [Google Scholar]
  7. HuangH.Y. LaiY.C. ChiuC.W. YehJ.M. Comparing micellar electrokinetic chromatography and microemulsion electrokinetic chromatography for the analysis of preservatives in pharmaceutical and cosmetic products.J. Chromatogr. A20039931-215316410.1016/S0021‑9673(03)00395‑912735448
     [Google Scholar]
  8. WangP. DingX. LiY. AngU. Simultaneous determination of eleven preservatives in cosmetics by micellar electrokinetic chromatography.J. AOAC Int.20129541069107310.5740/jaoacint.11‑04322970574
     [Google Scholar]
  9. PoltronieriA. PriviteraS. SalviA. Method for determination of the microbiological assay of imidazolidinyl urea.J. Soc. Cosmet. Chem.198536313318
     [Google Scholar]
  10. SottofattoriE. AnzaldiM. BalbiA. TonelloG. Simultaneous HPLC determination of multiple components in a commercial cosmetic cream.J. Pharm. Biomed. Anal.1998181-221321710.1016/S0731‑7085(98)00173‑39863960
     [Google Scholar]
  11. SarfrazS. HussainS. JavedM. RazaA. IqbalS. AlrbyawiH. AljazzarS.O. ElkaeedE.B. SomailyH.H. PashameahR.A. AlzahraniE. FaroukA.E. Simultaneous HPLC determination of clindamycin phosphate, tretinoin, and preservatives in gel dosage form using a novel stability-indicating method.Inorganics2022101016810.3390/inorganics10100168
     [Google Scholar]
  12. DoiT. TakedaA. AsadaA. KajimuraK. Characterization of the decomposition of compounds derived from imidazolidinyl urea in cosmetics and patch test materials.Contact Dermat.201267528429210.1111/j.1600‑0536.2012.02073.x22564140
     [Google Scholar]
  13. DoiT. TakedaA. AsadaA. KiyotaK. TagamiT. YamanoT. The development of dual-function solid-phase method as extraction and a decomposition reaction media for the determination of a formaldehyde releaser, imidazolidinyl urea, in cosmetics.Anal. Chim. Acta2022119133889110.1016/j.aca.2021.33889135033244
     [Google Scholar]
  14. ICH Q2 (R1)Validation of analytical procedures: Text and methodology.2005Avilable From: https://database.ich.org/sites/default/files/Q2%28R1%29%20Guideline.pdf (Accessed October 8, 2023).
/content/journals/cpa/10.2174/0115734129293343240604061830
Loading
Development and Validation of New HPLC Method for the Determination of Imidazolidinyl Urea in Topical Formulation
Current Pharmaceutical Analysis 20, 321 (2024); https://doi.org/10.2174/0115734129293343240604061830
/content/journals/cpa/10.2174/0115734129293343240604061830
/content/journals/cpa/10.2174/0115734129293343240604061830
Loading

Data & Media loading...


  • Article Type:     Research Article
Keyword(s): antimicrobial preservative; DAD; HPLC; Imidazolidinyl urea; topical formulation; validation

Most Cited Most Cited RSS feed

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test