Development and validation of high-performance thin-layer chromatography and MS-MS method for estimation of terizidone in pharmaceutical dosage form.

Objective: Estimation of terizidone in pharmaceutical dosage form by using high-performance thin-layer chromatography (HPTLC) CAMAG system. Materials and Methodology: The separation was achieved using precoated silica gel 60 F254 aluminum plates with mobile phase toluene: n-Butanol 9:1 mL % v/v at wavelength 268 nm. Results: The linearity range was found between 50 and 300 ng/mL-band having correlation coefficient 0.997. The recovery study of method showed the recovery between 99.3% and 101.6%. The limit of detection (LOD) and limit of quantification (LOQ) values for method were 0.981 and 2.973, respectively. The R.S.D. of precision study was <2. The method parameters were validated as per the ICH guidelines. The forced degradation studies revealed that the drug found stable in acidic, thermal, and photodegradation. Conclusion: The liquid chromatography-mass spectrometry study of degraded products gave the idea about the fragmentation patterns of degraded products. The developed method can be used for routine analysis of terizidone and its formulations. [ABSTRACT FROM AUTHOR]