Stability Indicating HPLC Method for the Simultaneous Estimation of Triamcinolone Acetonide and Benzyl Alcohol in Pure Form and Epirelefan® Vial

A rapid, sensitive, and accurate stability indicating HPLC method was developed for the simultaneous determination of triamcinolone acetonide and benzyl alcohol in pure form, degradation products and pharmaceutical preparation. The separation was carried out on RP BDS Hypersil® C18 column (150 x 4.60 mm, 5μm) using an isocratic mobile phase composed of acetonitrile: 0.05 M phosphate buffer PH 3.50 (55 : 45). Both benzyl alcohol and triamcinolone acetonide quickly eluted at 1.67 min and 3.42 min, respectively, with a flow rate of 1.50 mL /min and UV detection at 254 nm. The linearity was in the range of 1 – 50 µg/mL for triamcinolone acetonide and 2 - 10 µg/mL for benzyl alcohol. The method has been validated for linearity, accuracy, precision, specificity, limit of detection, limit of quantification, robustness, and ruggedness as per the ICH guidelines. Finally, the method was compared statistically with reference methods indicating that there is no significant difference between them in respect of precision and accuracy.