ABSTRACT:
Stability Indicating Forced Degradation Studies was carried out to Assess Degradation Behaviour of Chlordiazepoxide and Amitriptyline Hydrochloride in Pharmaceutical Dosage Form by RP-HPLC. The HPLC conditions consists of methanol Buffer: Acetonitrile: THF (50:20:30 v/v/v) mobile Phase, µBondapak C18 column (300 x 3.9 mm,10 µm particle size), wavelength (254nm). The method was validated according to ICH Guidelines. The validation parameters, linearity range, recovery, robustness and sensitivity was studied. Linearity for Chlordiazepoxide in the range of 50-200µg/mL and R2 Value 0.9999 and Amitriptyline hydrochloride 125-500µg/mL R2 value 0.9998. The percentage recovery of Chlordiazepoxide was found to be 98.75- 98.99% and for Amitriptyline Hydrochloride it was found to be 99.66 - 99.49% and the limit of detections (LOD) are 0.258µg/ml and 0.283µg/ml for Chlordiazepoxide and Amitriptyline hydrochloride, respectively. The developed method is simple, specific, precise and cost effective for estimation of Chlordiazepoxide and Amitriptyline Hydrochloride. Hence developed method was stability indicating and can be used for routine analysis of production samples and also check the stability of bulk and pharmaceutical formulation. The developed method was superior when compared to the reported method with less retention time and composition of the mobile phase with good separation.