Thu, 14 Dec 2017

RP HPLC Method Development and Validation for the Estimation of Fenoverine In Bulk Drug and Dosage Form

Haritha G1, Naresh K*1, Padmavathi Y1, Madhav Reddy B1

1.G. Pulla Reddy College of Pharmacy, Mehdipatnam, Hyderabad, Telangana, India


ABSTRACT

A new simple and sensitive RP-HPLC method was developed and validated as per the ICH guidelines for the estimation of fenoverine in bulk and pharmaceutical dosage form. The chromatographic separation was achieved  on Enable 18H C18  column (250 x 4.6mm, 5µm)  with a mobile phase containing acetonitrile and phosphate buffer pH 7 (55:45) at flow rate of 0.8ml/min using in isocratic elution mode. Detection was carried out at 262nm with the retention time of 4.7mins. Linearity in the calibration plot was achieved over the concentration range of 5-25ng/ml with an r2 value of 0.997. The method was validated for accuracy, precision, specificity and selectivity, robustness, detection and quantification limits and system suitability parameters according to ICH guidelines Q2 R1. The detection limit and quantitation limit were found to be 1.3ng/ml and 4ng/ml respectively. Further the validated method was successfully applied for the analysis of fenoverine in bulk and pharmaceutical dosage forms.

Keywords: Fenoverine, RP HPLC, Validation.


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