Abstract

SIMULTANEOUS ASSESSMENT OF VILANTEROL, FLUTICASONE FUROATE, AND GLYCOPYRRONIUM IN TRIPLE COMBO INHALATION CAPSULES APPLYING HPLC/PDA APPROACH

K. Anil Kumar, Y. Pavani, S.V.M. Vardhan and M. Subbarao*

ABSTRACT

In this study, a simple and reliable “High-performance liquid chromatography (HPLC)” assay to quantify VL, FF, and GF in commercial products and bulk samples is designed and validated. The stationary phase for the separation along with analysis of VL, FF, and GF was an Xterra C18 analytical column. The mobile phase was composed of 55% volume proportion of 0.01M KH2PO4, pH-3.2 and 45% volume proportion of methanol, at a rate of flowing of 1.0 mL/min was utilized throughout delivery of mobile phase into column. We measured peak areas of VL, FF, and GF at a wavelength of 247 nm. The present HPLC-VL/FF/GF assay methodology had correlation coefficient values of 0.99999 for VL, 0.99989 for FF and 0.99992 for GM, and was linear in 12.5 to 37.5 µg/mL range for VL, 50 to 150 µg/mL range for FF, and 25 to 75 µg/mL range for GM. The current protocol for VL, FF, and GF measurement was also rapid (run time < \ 10.0 min), accurate (%assay = 99.10% to 99.52%), precise (% RSD = 0.048% to 0.152%), and sensitive. The present HPLC-VL/FF/GF assay methodology demonstrated its stability-indicating qualities by being able to discriminate between VL, FF, GF and their degradation products in situation of various applied stresses. The triple combo inhalation capsule's content of VL, FF, and GM were all successfully determined using HPLC-VL/FF/GM assay approach. These results revealed that the proposed method may be used on a regular basis to assess VL, FF, and GF in triple combo inhalation capsules and degradation samples.

Keywords: Lung disease, triple combo, inhalation capsule, quality control, stability indicating.