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THE PHARMA REVIEW (MARCH - APRIL 2013)

RP-HPLC Method for Estimation of Nitroxazepine Hydrochloride in Pharmaceutical Preparations

R. B. Kakde & S. G. Rangari

Introduction: A simple, precise and accurate reverse phase HPLC method has been established for determination of Nitroxazepine HCl in bulk drug and pharmaceutical preparations. The chromatographic development of Nitroxazepine HCl was done on reverse phase RP-C18 column using mobile phase containing mixture of acetonitrile, 0.05 M ammonium acetate pH was adjusted to 6.1 0.01, Methanol in the ratio 94:3:3, v/v/v. The peak was obtained using UV-detector at wavelength 268 nm. A flow rate of 1 ml/min with 25oC column oven temperature was found to be optimum. The retention times under optimized chromatographic conditions was found to be 4.7 min with asymmetry of 1.072. The total run time of chromatogram was about 6 min. Stock solution of standard and formulation was prepared in methanol and further dilutions were also carried out with methanol, to obtain solution of 10ug/ml. The theoretical plates per meter (18164.80) indicate substantially high column efficiency. Calibration graph was found to be linear over the concentration range 1-16 g/ml with limit of detection 1.596 g/ml and limit of quantitation 4.835 g/ml. The results of estimation of marketed tablet formulation were found to be 99.87 u0.566 %. Recovery was found to be 100.99 u1.332%. The developed method was validated using various validation parameters such as accuracy, precision, specificity, limit of detection, limit of quantitation and ruggedness, which make method as choice for routine quality control analysis for estimation of Nitroxazepine HCl in the formulation.

 

 

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