Development and validation of a cost-effective, efficient, and robust liquid chromatographic method for the simultaneous determination of the acetyl and succinoyl content in hydroxypropyl methylcellulose acetate succinate polymer.

Development and validation of a cost-effective, efficient, and robust liquid chromatographic method for the simultaneous determination of the acetyl and succinoyl content in hydroxypropyl methylcellulose acetate succinate polymer. Research Abstract Details 

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Development and validation of a cost-effective, efficient, and robust liquid chromatographic method for the simultaneous determination of the acetyl and succinoyl content in hydroxypropyl methylcellulose acetate succinate polymer. Abstract Text:

A reversed-phase liquid chromatographic method was developed and validated for the determination of the content of free acetic acid, free succinic acid, acetyl substituents, and succinoyl substituents in hydroxypropyl methylcellulose acetate succinate (HPMCAS; Chemical Abstracts Service Registry No. 71138-97-1) polymer. This single new method gave accurate and precise measurement of both acetyl and succinoyl substituents, which had previously required 3 Japanese Pharmaceutical Excipients (JPE) methods to accomplish. Consequently, analysis time and turnaround time are decreased significantly. Furthermore, this method can also separate and determine the free acetic and succinic acids in HPMCAS polymer, a task that the corresponding JPE method cannot achieve. The values for accuracy (average recovery from 12 standard samples) were 99.9% for acetic acid and 99.8% for succinic acid. The values for injection precision (relative standard deviation [RSD]) were 0.11% for acetic acid and 0.28% for succinic acid. The values for intermediate precision (RSD) were 1.25% for determination of the acetyl content at the 8.78% (w/w) level and 1.33% for determination of the succinoyl content at the 10.9% (w/w) level. The values for intermediate precision (RSD) were 5.98% for determination of free acetic acid at the 0.12% (w/w) level and 5.13% for determination of free succinic acid at the 0.029% (w/w) level. The method was proven to be robust with respect to variation in the pH of the mobile phase, the concentration of potassium dihydrogen phosphate, and the flow rate. The method is well suited for quality control in today's fast-paced pharmaceutical laboratories.

Development and validation of a cost-effective, efficient, and robust liquid chromatographic method for the simultaneous determination of the acetyl and succinoyl content in hydroxypropyl methylcellulose acetate succinate polymer. Publishing Authors By Initials

For similar organic chemicals: carboxylic acids: acids, acyclic: dicarboxylic acids: succinic acids: succinic acid: succinates research abstracts see: organic chemicals: carboxylic acids: acids, acyclic: dicarboxylic acids: succinic acids: succinic acid: succinates research

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Development and validation of a cost-effective, efficient, and robust liquid chromatographic method for the simultaneous determination of the acetyl and succinoyl content in hydroxypropyl methylcellulose acetate succinate polymer. Journal Published:

PUBLICATION TYPE: Validation Studies

Journal: Journal of AOAC International

VOLUME: 85

Page Numbers: 824-31

Journal Abbreviation: J AOAC Int

ISSN: 1060-3271

DAY: 17

MONTH: 03

YEAR: 2008

Development and validation of a cost-effective, efficient, and robust liquid chromatographic method for the simultaneous determination of the acetyl and succinoyl content in hydroxypropyl methylcellulose acetate succinate polymer. Information

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LANGUAGE: eng

NlmUniqueID: 9215446

Development and validation of a cost-effective, efficient, and robust liquid chromatographic method for the simultaneous determination of the acetyl and succinoyl content in hydroxypropyl methylcellulose acetate succinate polymer. Keywords Mesh Terms:

KEYWORDS: Succinates

MESH TERMS: analysis

Chemical & Substance for Abstract: Development and validation of a cost-effective, efficient, and robust liquid chromatographic method for the simultaneous determination of the acetyl and succinoyl content in hydroxypropyl methylcellulose acetate succinate polymer. Information

Substance Name: Methylcellulose

Registry Number: 9004-67-5

Grant and Affiliation Information for Development and validation of a cost-effective, efficient, and robust liquid chromatographic method for the simultaneous determination of the acetyl and succinoyl content in hydroxypropyl methylcellulose acetate succinate polymer.

AFFILIATION: Pfizer Global Research and Development, Pharmaceutical Sciences, Analytical R/D, Groton Laboratories, CT 06340, USA. raymond_chen@groton.pfizer.com

Country: United States

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MEDLINETA: J AOAC Int

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