Development and Validation of a RP-HPLC Method for the Estimation of Amlexanox in Oral Paste Dosage Form

Abstract

A simple, reproducible and efficient reversed phase high performance liquid chromatographic (RPHPLC)
method has been developed for the estimation of a recently approved anti allergic drug, amlexanox in oral
paste dosage form. The separations were carried out on a Zorbax Eclipse XBD, C18 column (150 x 4.6 mm; 5μm) at a
flow rate of 1.50 ml/min. by using mobile phase comprising of mixed buffer (pH adjusted to 6.50) and methanol
(50:50 v/v). The injection volume was 10 μl and the peaks were detected at 244 nm. The linear dynamic range found
to be in the concentration range of 15-35 μg/ml and coefficient of correlation was found to be 0.999. The %RSD
value was below 2.0 for intra-day and inter-day precision which indicated that the method was highly precise. The
LOD (Limit of detection) and LOQ (Limit of quantitation) were found to be 3.8 ng/ml and 12.5 ng/ml, respectively
which revealed that the method was highly sensitive. The percentage recovery of amlexanox ranged from 99.31 to
99.75%, indicating the accuracy of the method and absence of interference from the excipients present in the
formulation. The proposed method was simple, fast, accurate and re