Stability-indicating HPLC method for the determination of impurities in meprobamate with refractive index detection.
J Chromatogr Sci
; 48(3): 212-8, 2010 Mar.
Article
in En
| MEDLINE
| ID: mdl-20223088
ABSTRACT
The purpose of this study is to develop and validate a simple, sensitive, and robust high-performance liquid chromagraphic (HPLC) method for the determination of impurities ca. 2-methyl-2-propyl-1,3-propane diol (MP0) and 2-hydroxymethyl-2-methyl pentyl carbamate (MP1) in meprobamate (MEP) drug substance with refractive index (RI) detection. This method utilizes a Zorbax Eclipse XDB C(18) HPLC column, a mobile phase of 8020 (v/v) 10 mM KH(2)PO(4),-acetonitrile, respectively. The stability-indicating capability of the method has been established by performing stress studies under acidic, basic, oxidation, light, humidity, and thermal conditions. The major degradation products of acid and base hydrolysis are identified as MP0 and MP1. The recovery data obtained for impurities are between 96.0-109.8%. The detection and quantitation limits of this method ranges from 0.009 to 0.017 mg/mL and 0.029 to 0.055 mg/mL, respectively. The relative standard deviation (RSD) for the area at QL is less than 6.1%. Good linearity (r(2) > 0.99) and precision (RSD < 2.2%) have been obtained for MEP, MP0, and MP1. This method has been applied successfully to determine the content of impurities in MEP bulk drug.
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Collection:
01-internacional
Database:
MEDLINE
Main subject:
Refractometry
/
Drug Contamination
/
Chromatography, High Pressure Liquid
/
Meprobamate
/
Muscle Relaxants, Central
Type of study:
Diagnostic_studies
Language:
En
Journal:
J Chromatogr Sci
Year:
2010
Document type:
Article
Affiliation country:
India