STABILITY INDICATING ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF AVANAFIL IN PHARMACEUTICAL DOSAGE FORM

Abstract

Analysis of pharmaceutical product is very important as it concerned with life. A stability-indicating assay accurately
measures the active ingredients, without interference from degradation products, process impurities, excipients, or other
potential impurities. Stability of the pharmaceutical product is most important, so that work is carried out to develop a new,
simple, precise, accurate, validated stability indicating Analytical method for estimation of Avanafil in Pharmaceutical
Dosage Form. In this method Acetonitrile: Water: Triethylamine: Acetic Acid in the ratio (65:35:0.1:0.1) was used as a
mobile phase, so that developed method becomes ecofriendly. The detection was carried out at 254 nm and a flow rate of 1
mL/min and retention time 4.7 min. and C18 column was used for the separation of drug with other degraded product and
process impurities. The linearity was observed in the range of 50–150 ppm. The developed method was meets all the
acceptance criteria for the validation of analytical method as per the ICH guideline. The degradation of the drug in acid,
alkali, oxidation, Thermal was found to be 2.78%, 4.00%, 2.06%, 1.48% respectively and it meets acceptance criteria for
the stability of the pharmaceutical product as per ICH guideline. The assay of drug was found in acceptance range.