ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR QUANTIFICATION OF EXEMESTANE IN NANOEMULSION BY RP HPLC

Abstract

A simple, precise, reproducible and sensitive RP HPLC method was developed and validated for the quantification of exemestane (EXM) in nanoemulsion. The method was developed using Phenomenex C18 column (250 mm × 4.6 mm i.d., 5 µm) and acetonitrile: methanol (40:60 V/V) was used as mobile phase. The flow rate was maintained at 1.0 mL min-1. The analyte was monitored at 249 nm. The analyte shows linear response in the range of 0.5–5 µg mL-1. The developed method was validated as per ICH guidelines for accuracy, precision, limit of detection, limit of quantitation and robustness. The data for precision studies revealed that the method is precise, as % RSD is less than 2. The standard addition method was used for the accuracy study and the method showed 100.3 ± 0.47 % recovery for the drug. The proposed method can be successfully applied to the dosage form.