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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