Abstract
COMBINED QUANTIFICATION OF FORMOTEROL FUMARATE AND GLYCOPYRROLATE BY STABILITY INDICATING RP-HPLC METHOD WITH PHOTODIODE ARRAY DETECTOR

Battula Sreenivasa Rao, Mandapati Varaprasad Reddy* and Bhatraju Sreenivasa Rao

ABSTRACT

The current study involves development and validation of a stability-indicating RP-HPLC method with photodiode array detector for the combined estimation of formoterol fumarate and glycopyrrolate. Formoterol fumarate and glycopyrrolate was subjected to acid, alkaline, oxidative, thermal and photo degradation conditions. The chromatographic separation was carried out using a Sunsil C18 (250 × 4.6 mm; 5 μm particle size) column and phosphate buffer (pH 4.5): methanol (60:40 v/v) as the mobile phase. The formoterol fumarate, glycopyrrolate and their degradation products were detected at 289 nm. The linearity was observed in the range of 18-54 μg/mL (formoterol fumarate) and 9.6-28.8 μg/mL (glycopyrrolate). The limit of quantitation for formoterol fumarate and glycopyrrolate were found to be 1.116 μg/mL and 0.386 μg/mL, respectively. The percentage recovery was found in the range of 100.15-100.44% for formoterol fumarate and 99.66-99.74% for glycopyrrolate. Formoterol fumarate and glycopyrrolate was degraded under all the forced conditions applied. The method was able to resolve the degradation product from the peaks of analytes. Therefore, the developed and validated method can be applied for simultaneous estimation of formoterol fumarate and glycopyrrolate in the presence of the forced degradation products.

Keywords: Formoterol fumarate, Glycopyrrolate, RP-HPLC, Forced degradation, Analysis.


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