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Simultaneous determination of Choline citrate and acetylmethionine in injectable solutions by high performance liquid chromatography

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715 ISSN 0326-2383

KEY WORDS: Acetylmethionine, Choline citrate, HPLC, Injectable solutions, Method validation. * Author to whom correspondence should be addressed. E-mail:[email protected]

Latin American Journal of Pharmacy

(formerly

Acta Farmacéutica Bonaerense)

Lat. Am. J. Pharm.

30

(4): 715-20 (2011)

Original Article Received: February 11, 2010 Revised version: February 14, 2010 Accepted: February 4, 2010

Simultaneous Determination of Choline Citrate and Acetylmethionine in

Injectable Solutions by High Performance Liquid Chromatography

Grazielle P. ALEXANDRE, Maria S. AURORA-PRADO, Erika R.M. KEDOR-HACKMANN,

Anil K. SINGH & Maria Inês R.M. SANTORO *

Department of Pharmacy, Faculty of Pharmaceutical Sciences,

University of São Paulo, CP 66083, CEP 05315-970,São Paulo, SP, Brazil

SUMMARY.Choline citrate (CC) and acetylmethionine (AM) are lipotropic drugs used in several pharma-ceutical formulations. The objective of this research was to develop and validate a high performance liquid chromatographic (HPLC) method for simultaneous determination of CC and AM in injectable solutions, aiming its application in routine analysis for quality control of these pharmaceutical formulations. The method was validated using a Shim-Pack® C18 (250 x 4.6 mm, 5 μm) column. The mobile phase was con-stituted of 25 mM potassium phosphate buffer solution, pH 5.7, adjusted with 10 % orthophosphoric acid, acetonitrile and methanol (88:10:2, v/v/v). The flow rate was 1.1 mL.min–1and the UV detection was made

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