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

Abstract

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.

Experimental Design Approach for Development of HPLC Method for Simultaneous Analysis of Triamcinolone, Nystatin, and Gramicidin in Industrial Wastewater

“…Antimicrobials, antifungals, and corticosteroids are widely used pharmaceutical drugs detected in aquatic systems. In the literature review, we found that triamcinolone has been detected in ointment formulation [4], in human plasma [5], in biodegradable microparticles [6], in dosage form [7,8], and in bulk pharmaceutical formulation using an HPLC-UV detector and HPTLC-UV detector [9]. Nystatin has been detected in plasma and tissue with an HPLC-UV detector [10], in saliva with an HPLC-UV and fluorescence detector [11], and also with ay chemometric and HPLC-UV detector [12].…”

“…Sebaiy et al established a stability indicating HPLC for the determination of benzyl alcohol and triamcinolone in tablet dosage form using a C18 column (150 mm × 4.60, 5 µm), and the studied drugs were eluted at 1.67 min. and 3.42 min, respectively [8]. Despite the fact that this established method was successful in separating the two drugs, the benzyl alcohol eluted early and close to the dead volume, according to the analytical column that was used.…”