Abstract

DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL, ACECLOFENAC AND SERRATIOPEPTIDASE IN COMBINED TABLET DOSAGE FORM

Adidala Raghuram Reddy*, K. Rajamani, Arrabelli Mounika,
Gouru Santhosh Reddy

ABSTRACT

A Simultaneous estimation of RP-HPLC method was developed and validated for the estimation of paracetamol, aceclofenac and serratiopeptidase in tablet dosage form using C18 column (250mm 4.6mm, 5μ) with mobile phase consisting of Acetonitrile: Water (70:30v/v) and 0.1% Glacial acetic acid with a flowrate of 1.0ml/min and UV detection at 227nm. Recovery was observed 99.1% to 99.4% for Mankind, 98.64% to 99.1% for Nelnac, 98.9% to 99.5% Lupin Tablets. Accuracy of drugs was observed to be within the limits of 98% to 102% by mean of 3 determinations. Precision of drugs was observed to be less than 2.0 of %RSD by mean of 6 determinations. Linearity was observed over the concentration range 1–50 μg/ml (r2=0.998) with regression equation y = 36941x – 61362 for Paracetamol, Aceclofenac 1–50 μg/mL (r2=0.997) with regression equation y = 42784x + 23799 and Serratiopeptidase 1-50 μg/mL (r2= 0.998) with regression equation y = 1904x + 22854. LOD and LOQ of Paracetamol, aceclofenac and serratiopeptidase were found to be 2.27μg/ml, 1.1μg/ml, 3.62μ/ml and 6.88μg/ml, 3.33μ/ml, 10.9μg/ml respectively. The method was validated as per ICH guidelines.

Keywords: Aceclofenac, Paracetamol, Serratiopeptidase, HPLC, Method development, Method validation.