RP-HPLC method for the estimation of nitroxazepine hydrochloride in pharmaceutical dosage forms.
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Date
2010-11
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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
(70:30) 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.
Description
Keywords
Nitroxazepine hydrochloride, RP‐HPLC, Validation, Pharmaceutical formulation
Citation
Praveen P Sai, Anupama B, Sirisha P, Reddy Y Hanuma, Reddy T V B. RP-HPLC method for the estimation of nitroxazepine hydrochloride in pharmaceutical dosage forms. International Journal of Applied Biology and Pharmaceutical Technology. 2010 Nov-Dec; 1(3): 1181-1187.