RP-HPLC method for the estimation of nitroxazepine hydrochloride in pharmaceutical dosage forms.

ABSTRACT

A simple and sensitive isocratic RP‐HPLC method was developed for the determination of Nitroxazepine hydrochloride in bulk drug and its pharmaceutical tablet formulations where the mobile phase optimized was Phosphate buffer Acetonitrile (7030) and Phenomenex C18 column (250 mm length, 4.6 mm internal diameter and particle size 5 μm) was used as the stationary phase. The flow rate and detection wavelength was 1.0 mL min‐1 and 265 nm respectively. The developed method was validated as per ICH guidelines for specificity, linearity and range, precision, accuracy, robustness, limit of quantification and limit of detection. The results of all the validation parameters were well within their acceptance values. The method gave good recovery in the range of 98.95‐99.43 % for Nitroxazepine hydrochloride when it was applied for its determination in pharmaceutical tablet formulations.