Abstract
A VALIDATED GC-MS METHOD FOR THE DETERMINATION OF 3-(TRIFLUOROMETHYL)-CINNAMALDEHYDE CONTENT IN CINACALCET HYDROCHLORIDE DRUG SUBSTANCE

Singireddy Raghavender Reddy*, Katreddi Hussain Reddy, Masani Narendra Kumar, Peddolla Madhava Reddy, Junnutula Venkata Ramana Reddy and Hemant Kumar Sharma

ABSTRACT

A specific GCMS method has been developedand validated for the determination of 3-(Trifluoromethyl)-cinnamaldehyde (TFMCA) content in Cinacalcet hydrochloride (CCHC) drug substance. Efficient chromatographic separation was achieved on DB-1 column (30 m x 0.32 mm, 1.0 μm), consists of 100% dimethyl polysiloxane material as stationary phase by passing helium as carrier gas. Dichloromethane (DCM) is used as diluent and TFMCA, CCHC were dissolved in DCM and monitored by gas chromatography electron ionization mass spectrometry (GC-EI-MS) with selective ion monitoring (SIM) mode. The mass fragments (m/z) selected for TFMCA quantification was m/z 131 and m/z 199 was the qualifier ion for the analysis. The performance of the developed method was assessed by evaluating specificity, linearity, sensitivity, precision and accuracy. The established limits of detection (LOD) and limits of quantification (LOQ) values for TFMCA was 0.0166 μg mL-1 and 0.0332 μg mL-1 respectively. The correlation co-efficient value of linearity experiment was 0.9997 and the average recovery was 111.7%. The results proved that the method is suitable for the determination of TFMCA content in Cinacalcet hydrochloride and method can be successfully applied for the quality control analysis of Cinacalcet hydrochloride drug substance.

Keywords: Gas chromatography, Cinacalcet hydrochloride, Validation, Development, Content.


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