Abstract

RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF SERATRODAST IN BULK AND PHARMACEUTICAL DOSAGE FORM

Dr. B. V. Narasimha Rao*, K. Gayathri Devi, A. Udaya Krishna Veni, A. Hrithik Narendra, CH. Chandu Lokesh, K. Seetharamaiah and M. Bhavani

ABSTRACT

The current study developed and validated a reverse phase high performance liquid chromatography method for estimating seratrodast in pharmaceutical formulations and bulk. By adjusting several technique parameters, including buffer concentration, mobile phase ratio, and column type, statistically planned experiments were conducted to evaluate the impact of method factors on the chromatographic separation of seratrodast. Using potassium dihydrogen orthophosphate buffer pH 6.8: Acetonitrile in a 60:40 (v/v) ratio under isocratic conditions at a flow rate of 1.0 mL/min, the separation was carried out on a Betasil C18 Column (300 x 4 mm and 5μm) at room temperature. A photo diode array (PDA) detector operating at 263 nm for a total of 8 minutes made the detection. In the concentration range of 20–120 μg/mL, calibration curves were linear. The sensitivity of the devised approach is demonstrated by theobserved LOD of 2μg/mL and the calculated LOQ of 8.1μg/mL. The method's robustness and ruggedness were confirmed by the %RSD being less than 2. In formulation analysis, the test percentage was 99.11. Therefore, the technique was used to the routine analysis of seratrodast in pharmaceutical formulations and in bulk drug.

Keywords: Seratrodast, Precision, Linearity, Ruggedness and Robustness, etc.