Sat, 18 Nov 2017

Ultra Performance Liquid Chromatography Method for the Determination of Degradation Impurities of Naftopidil in Naftopidil Orally Dispersible Tablets

Bhaskara P.V Mantena1,*, Sumathi V rao1, K.M.Ch.Appa rao2, K.Ramakrishna2, Jayant Karajgi1 and S.P. Vittal1

1.Aurobindo Pharma Limited (A division of APL Research centre), Survey No. 313, Bachupally, Quthubullapur Mandal, Ranga reddy District, Hyderabad-500072, Andhra Pradesh, India.

2.GITAM University, Gandhi Nagar, Rushikonda, Visakhapatnam-530 045. Andhra Pradesh, India


ABSTRACT

This paper describes a strategy for the systematic development and validation of stability-indicating method of the determination of degradation impurities present in Naftopidil Orally dispersible tablets.  Efficient separation is achieved in 75mm length x 2.1mm ID, Octadecyl column with 3µ particle size. Using pH 3.2 phosphate buffer and acetonitrile as mobile phase in gradient pump mode. Flow rate was selected 0.4mL.min-1with a detection wavelength of 210nm. Validation parameters such as specificity, linearity, precision, accuracy, determination of LOD,  LOQ and robustness were evaluated as per ICH guidelines. The validated Reverse phase –Ultra Performance liquid chromatography (RP-UPLC) method was successfully applied to the quantitative determination of impurities of Naftopidil in Naftopidil Orally Dispersible tablet dosage forms, helping to improve quality control and to assure therapeutic efficacy at reduced run time of minutes.

Keywords: Naftopidil, Forced Degradation, RP-UPLC and Stability Indicating


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