PAYAL CHAUHAN, RAKESH PARMAR, ANUJA TRIPATHI
Acta Pharmaceutica Sciencia - 2024;62(2):312-332
A novel, accurate, and specific stability-indicating RP-HPLC method for determining Chlordiazepoxide (CLR) and Trifluoperazine HCl (TFP) in drug substances and drug products has been developed. A forced degradation study was performed as per the ICH guideline for both drugs. The degradation of chlordiazepoxide and trifluoperazine HCl in bulk and formulation was tested under a variety of stress conditions, including acidic, alkaline, neutral, oxidative, thermolytic, and photolytic conditions. The Separation was done using a C18 (250 mm × 4.6 mm, 5?m) column as a stationary phase and 70:30%(v/v) Acetonitrile: Phosphate buffer (pH 5.5) adjusted with 0.1% Triethaylamine (TEA) as isocratic mobile phase. The flow rate was 1ml/min and the wavelength for detection was 262 nm. The retention time was 4.1min and 7.1min for Chlordiazepoxide and Trifluoperazine HCl respectively. The developed method was validated as per the ICH guideline Q2(R1). Specificity, linearity, accuracy, precision, LOD, LOQ, robustness, and system suitability were checked to meet specified criteria. Specificity, linearity, precision, accuracy, LOD, LOQ, robustness, system suitability, and other criteria were analyzed, Chlordiazepoxide and Trifluoperazine HCl were susceptive to degradation in photolytic and thermal stress conditions. The method was proven to be appropriate for use in the analysis of Chlordiazepoxide and Trifluoperazine HCl formulations in quality-control laboratories.
