Asian Journal of Pharmaceutical Analysis

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Validated RP-Capillary HPLC-Dad Method for Simultaneous Analysis of Some Paraben Preservatives in Pharmaceutical and Cosmetics/personal Care Formulations


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1 Central Forensic Science Laboratory, Plot No 2, Sector 36 A, Dakshin Marg, Ministry of Home Affairs, Govt. of India, Chandigarh, India
     

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A fast and sensitive RP- capillary HPLC-DAD method that allows simultaneous determination of p-hydroxybenzoates commonly known as parabens in personal care formulations and pharmaceuticals is described in present study. Parabens are widely used as preservatives in cosmetics, pharmaceuticals and foods products. The separation was achieved on Agilent Zorbax SB C-18 narrow bore RR column using Acetonitrile: water as mobile phase. The results showed that separation is achieved for the target analytes within 10 min. The method was evaluated for analytical characteristics with respect to limit of detection, limit of quantification, linearity, interday and intraday precision, specificity, robustness and stability of standards. The calibration curves were linear with a correlation coefficient higher than 0.997 for each analyte. Relative standard deviation (%RSD) for inter and intraday precision studies were < 3.5% for all four parabens. Methyl Paraben was used as preservative in maximum formulations. The method was successfully applied to commercially available cosmetics and personal care formulations. The extraction process reported is easy and economical. The proposed method can be successfully put on board in quality control and testing laboratories.

Keywords

P-hydroxybenzoates, Parabens, Preservatives, RP-capillary HPLC, Cosmetics, Personal Care Products.
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  • Lee MR et al. Simultaneous analysis of antioxidants and preservatives in cosmetics by supercritical fluid extraction combined with liquid chromatography–mass spectrometry. Journal of Chromatography A. 2006; 1120 (1-2): 244–251.

  • Byford JR et al. Oestrogenic activity of parabens in MCF7 human breast cancer cells. The Journal of Steroid Biochemistry and Molecular Biology. 80 (1); 2002: 49–60.

  • Darbre PD et al. Oestrogenic activity of isobutylparaben in vitro and in vivo. Journal of Applied Toxicology. 22 (4); 2002: 219–226.

  • Routledge JE et al. Some alkyl hydroxy benzoate preservatives (parabens) are estrogenic. Toxicology and Applied Pharmacology. 153 (1); 1998: 12–19.

  • Darbre PD et al. Concentrations of parabens in human breast tumours. Journal of Applied Toxicology. 24 (1); 2004: 5–13.

  • Shanmugam G et al. GC–MS method for the determination of paraben preservatives in the human breast cancerous tissue. Microchemical Journal. 96 (2); 2010: 391–396.

  • BIS. Classification of Cosmetics Raw Materials and Adjuncts, Part 2, (3rd Revision). Bureau of Indian Standards, New Delhi. 2009.

  • JECFA. Sixty-seventh report of the Joint FAO/WHO Expert Committee on Food Additives: Geneva. 2006.

  • Bajaj A and John C. Simultaneous determination of p-hydroxybenzoate preservatives in pharmaceuticals and personal care formulations. Asian Journal of Research in Chemistry 8(6); 2015: 394-398.

  • Copius-Peereboom JW. Foodstuffs and Their Additives. In Thin Layer Chromatography- A laboratory hand book, Edited by Stahl E Springer, India. 2009 2nd ed: pp. 630-656.

  • Shabir GA. Determination of combined p-hydroxy benzoic acid preservatives in a liquid pharmaceutical formulation by HPLC. Journal of Pharmaceutical and Biomedical Analysis. 34(1); 2004: 207-213.

  • Kumar S et al. Development and validation of a single RP-HPLC assay method for analysis of bulk raw material batches of four parabens that are widely used as preservatives in pharmaceutical and cosmetic products. Journal of Chromatographic Science. 49(5); 2011: 405-411.

  • 13 Saraji M and Mirmahdieh S. Single-drop micro extraction followed by in-syringe derivatization and GC-MS detection for the determination of parabens in water and cosmetic products. Journal of Separation Science. 32(7); 2009: 988-95.

  • Gonzalez MI. et al. Simultaneous determination of parabens, triclosan and triclocarban in water by liquid chromatography/ electrospray ionisation tandem mass spectrometery. Rapid Communication in Mass Spectrometry. 23(12); 2009: 1756-1766.

  • Mirzaie A, Jamshidi A and Husain SW. TLC quantification of Methyl paraben on an Inorganic Ion-Exchanger in presence of other food additives. Journal of Planar Chromatography - Modern TLC. 20(2); 2007: 141-143.

  • Thomassin M. et al. Comparison of quantitative high performance thin layer chromatography and the high performance liquid chromatography of parabens. Journal of Pharmaceutical and Biomedical Analysis 15(6); 1997: 831-838.

  • Frederiksen F, Jorgensen N and Anderson AM. Parabens in urine and seminal plasma from healthy Danish men determined by liquid chromatography- tandem mass spectrometry (LC-MS/MS). Journal of Exposure Science and Environmental Epidemiology. 21(3); 2011: 262-271.

  • Pedrouzo M. et al. Ultra-high-performance liquid chromatography-tandem mass spectrometry for determining the presence of eleven personal care products in surface and wastewaters. Journal of Chromatography A. 1216 (42); 2009: 6994-7000.

  • Saad B. et al. Simultaneous determination of preservatives (benzoic acid, sorbic acid, methyl paraben and propyl paraben) in foodstuffs using HPLC. Journal of Chromatography A. 1073(1-2); 2005: 393-397.

  • Msagati TA. et al. Analysis and quantification of parabens in cosmetic products by utilizing hallow fibre-supported liquid membrane and high performance liquid chromatography with ultraviolet detection. International Journal of Cosmetic Science. 30(4); 2008: 297-307.

  • Hewala I. et al. Development and application of a validated stability-indicating high-performance liquid chromatographic method using photodiode array detection for simultaneous determination of granisetron, methylparaben, propylparaben, sodium benzoate, and their main degradation products in oral pharmaceutical preparations. Journal of AOAC International. 94(5); 2011: 1447-1460.

  • Cabaleiro N. et al. Current trends in liquid–liquid and solid–liquid extraction for cosmetic analysis: A Review. Analytical Methods. 5; 2013: 323-340.

  • Gonzaleza JAO. et al. (2015) New developments in the extraction and determination of parabens in cosmetics and environmental samples. A review. Analytica Chimica Acta. 858; 2015:1-15.


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  • Validated RP-Capillary HPLC-Dad Method for Simultaneous Analysis of Some Paraben Preservatives in Pharmaceutical and Cosmetics/personal Care Formulations

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Authors

Atul Bajaj
Central Forensic Science Laboratory, Plot No 2, Sector 36 A, Dakshin Marg, Ministry of Home Affairs, Govt. of India, Chandigarh, India
Cijo John
Central Forensic Science Laboratory, Plot No 2, Sector 36 A, Dakshin Marg, Ministry of Home Affairs, Govt. of India, Chandigarh, India
Rohitashva Mani Tripathi
Central Forensic Science Laboratory, Plot No 2, Sector 36 A, Dakshin Marg, Ministry of Home Affairs, Govt. of India, Chandigarh, India
Joydip Choudhury
Central Forensic Science Laboratory, Plot No 2, Sector 36 A, Dakshin Marg, Ministry of Home Affairs, Govt. of India, Chandigarh, India

Abstract


A fast and sensitive RP- capillary HPLC-DAD method that allows simultaneous determination of p-hydroxybenzoates commonly known as parabens in personal care formulations and pharmaceuticals is described in present study. Parabens are widely used as preservatives in cosmetics, pharmaceuticals and foods products. The separation was achieved on Agilent Zorbax SB C-18 narrow bore RR column using Acetonitrile: water as mobile phase. The results showed that separation is achieved for the target analytes within 10 min. The method was evaluated for analytical characteristics with respect to limit of detection, limit of quantification, linearity, interday and intraday precision, specificity, robustness and stability of standards. The calibration curves were linear with a correlation coefficient higher than 0.997 for each analyte. Relative standard deviation (%RSD) for inter and intraday precision studies were < 3.5% for all four parabens. Methyl Paraben was used as preservative in maximum formulations. The method was successfully applied to commercially available cosmetics and personal care formulations. The extraction process reported is easy and economical. The proposed method can be successfully put on board in quality control and testing laboratories.

Keywords


P-hydroxybenzoates, Parabens, Preservatives, RP-capillary HPLC, Cosmetics, Personal Care Products.

References