A SENSITIVE AND VALIDATED GC METHOD FOR THE DETERMINATION OF MONOISOPROPYLAMINE CONTENT IN CARISOPRODOL DRUG SUBSTANCE
Singireddy Raghavender Reddy*, Katreddi Hussain Reddy, Masani Narendra Kumar, Peddolla Madhava Reddy, Junnutula Venkata Ramana Reddy, Gaddam Thirupathi Reddy, Dudupala Visnuvardhan and Hemant Kumar Sharma
ABSTRACT
A specific GC method has been developed and validated for the determination of Monoisopropylamine (MIPA) content in Carisoprodol (CP) drug substance using Diethylamine (DEA) as internal standard (IS). Efficient chromatographic separation was achieved on Rtx-5 capillary column (30 m x 0.53 mm, 5.0 μm), consists of 5% diphenyl and 95% dimethylpolysiloxane as stationary phase and passing nitrogen as carrier gas. In this method, in presence of ethyl chloroformate, pyridine and dichloromethane (DCM) solvent medium monoisopropylamine and diethylamine were converted to monoisopropylamine derivative and diethylamine derivatives respectively. Therefore, monoisopropylamine is monitored by flame ionization detector (FID) and quantified as monoisopropylamine derivative. The performance of the method was assessed by evaluating specificity, linearity, sensitivity, precision and accuracy. The established limits of detection (LOD) and limits of quantification (LOQ) values for MIPA were 0.5297 μg mL-1 and 1.0594 μg mL-1 respectively. The correlation co-efficient value of linearity experiment was 0.9999 and the average recovery was 103.7%. The results proved that the validated method is suitable for the determination of monoisopropylamine in carisoprodol drug and method successfully applied for the quality control analysis of carisoprodol drug substance.
Keywords: Gas chromatography, Carisoprodol, Development, Validation, Content.
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