A new validated HPLC method for the simultaneous determination of 2-phenoxyethanol, methylparaben, ethylparaben and propylparaben in a pharmaceutical gel

Indian Journal of Pharmaceutical Sciences

Volumn 72, Issue 4, 2010, Pages 421-425

  Shabir, G A ^a  

^a OXFORD BROOKES UNIVERSITY   (United Kingdom)

Author keywords

2 phenoxyethanol; ethylparaben; HPLC; method validation; methylparaben; pharmaceutical gel; propylparaben

Indexed keywords

2 PHENOXYETHANOL; ACETONITRILE; ETHYL PARABEN; METHYL PARABEN; PROPYL PARABEN; TETRAHYDROFURAN; WATER;

ARTICLE; CHEMICAL COMPOSITION; FLOW RATE; GEL; PH; REVERSED PHASE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; SENSITIVITY AND SPECIFICITY; TEMPERATURE SENSITIVITY; VALIDATION STUDY;

EID: 78650565872     PISSN: 0250474X     EISSN: 19983743     Source Type: Journal    
DOI: 10.4103/0250-474X.73906     Document Type: Article

References (22)

1. Shabir GA. Determination of combined p-hydroxy benzoic acid preservatives in a liquid pharmaceutical formulation and assay by HPLC. J Pharm Biomed Anal 2004;34:207-13.
2. Denyer SP, Baird RM. Preservatives: Registrations and regulatory affairs-Guide to Microbiological Control in Pharmaceuticals. West Sussex: Ellis Horwood; 1990. p. 314-40.
3. Perez- Lozano P, Garcia-Montoya E, Orriols A, Minarro M, Tico JR, Sune-Negre JM. A new validated method for the simultaneous determination of benzocaine, propylparaben, and benzyl alcohol in a bioadhesive gel by HPLC. J Pharm Biomed Anal 2005;39:920-7. (Pubitemid 41441720)
4. Sottofatori E, Anzaldi M, Balbi A, Tonello G. Simultaneous HPLC determination of multiple components in a commercial cosmetic cream. J Pharm Biomed Anal 1998;18:213-7. (Pubitemid 28529339)
5. Dvorak J, Hajkova R, Matysova L, Novakova L, Koupparis MA, Solich P. Simultaneous HPLC determination of ketoprofen and its degradation products in the presence of preservatives in pharmaceuticals. J Pharm Biomed Anal 2004;36:625-9. (Pubitemid 39441335)
6. Popovic G, Cakar M, Agbaba D. Determination of bifonazole in creams containing methyl- and propyl p-hydroxybenzoate by derivative spectrophotometric method. J Pharm Biomed Anal 2003;33:131-6. (Pubitemid 37297525)
7. Hajkova R, Solich P, Dvorak J. Simultaneous determination of methylparaben, propylparaben, hydrocortisone acetate, and its degradation products in a topical cream by RP-HPLC. J Pharm Biomed Anal 2003;32:921-7. (Pubitemid 36951966)
8. Koundourellis JE, Malliou ET, Broussali TA. High performance liquid chromatographic determination of ambroxol in the presence of different preservatives in pharmaceutical formulations. J Pharm Biomed Anal 2000;23:469-75. (Pubitemid 30599461)
9. Shabir GA, Lough WJ, Shafique AA, Shar GQ. Method development and validation for the HPLC assay of phenylformic acid, 2,4-hexadienoic acid, methyl 4-hydroxybenzoate and propyl 4-hydroxybenzoate. J Liq Chromatogr Relat Technol 2006;29:1223-33.
10. Dalibor S, Jitka HR, Ferreira LC, Maria C, Montenegro BS. Determination of ambroxol hydrochloride, methylparaben and benzoic acid in pharmaceutical preparations based on sequential injection technique coupled with monolithic column. J Pharm Biomed Anal 2006;40:287-93.
11. Kokoletsi MX, Kafkala S, Tsiaganis M. A novel gradient HPLC method for simultaneous determination of ranitidine, methylparaben and propylparaben in oral liquid pharmaceutical formulation. J Pharm Biomed Anal 2005;38:763-7. (Pubitemid 40835578)
12. Belgaied JE, Trabelsi H. Determination of cisapride, its oxidation product, propyl and butyl parabens in pharmaceutical dosage form by reversed-phase liquid chromatography. J Pharm Biomed Anal 2003;33:991-8. (Pubitemid 37501002)
13. Mahuzier PE, Altria KD, Clark BJ. Selective and quantitative analysis of 4-hydroxybenzoate preservatives by microemulsion electrokinetic chromatography. J Chromatogr A 2001;924:465-70. (Pubitemid 32721881)
14. Lee MR, Lin CY, Li ZG, Tsai TF. Simultaneous analysis of antioxidants and preservatives in cosmetics by supercritical fluid extraction combined with liquid chromatography-mass spectrometry. J Chromatogr A 2006;1120:244-51.
15. Grosa G, Grosso ED, Russo R, Allegrone G. Simultaneous, stability indicating, HPLC-DAD determination of guaifenesin and methyl and propyl-parabens in cough syrup. J Pharm Biomed Anal 2006;41:798-803. (Pubitemid 44269082)
16. Kokoletsi MX, Kafkala S, Tsiaganis M. A novel gradient HPLC method for simultaneous determination of ranitidine, methylparaben and propylparaben in oral liquid pharmaceutical formulation. J Pharm Biomed Anal 2005;38:991-8. (Pubitemid 40835578)
17. Shabir GA, Lough WJ, Shafique AA, Bradshaw TK. Evaluation and application of best practice in analytical method validation. J Liq Chromatogr Relat Technol 2007;30:311-33.
18. Shabir GA. Validation of HPLC methods for pharmaceutical analysis: Understanding the differences and similarities between validation requirements of the U.S. Food and Drug Administration, the U.S. Pharmacopoeia and the International Conference on Harmonization. J Chromatogr A 2003;987:57-66.
19. Shabir GA. Step-by-step analytical methods and protocol in the quality system compliance industry. J Validation Technol 2004;10:314-24.
20. International Conference on Harmonization (ICH), Validation of analytical procedures: Text and Methodology, Q2 (R1), Geneva, Switzerland: 2005.
21. Reviewer Guidance: Validation of Chromatographic Methods, Food and Drug Administration (FDA), Centre for Drug Evaluation and Research (CDER), November 1994.
22. US Pharmacopoeia (USP) 32, Chromatography, Section (621), Rockville MD: United States Pharmacopeal Convention; 2009. p.1776.