Method development and validation of simultaneous estimation of  glycopyrrolate and formoterol fumarate in its bulk form by RP-HPLC

Authors

Ayesha Begum K
editorijipsr@gmail.com
Shadan Women’s College of Pharmacy, Khairatabad, Hyderabad
Saba Khan Shadan Women’s College of Pharmacy, Khairatabad, Hyderabad
P. Sandhya Shadan Women’s College of Pharmacy, Khairatabad, Hyderabad
D. Ramakrishna Shadan Women’s College of Pharmacy, Khairatabad, Hyderabad

Glycopyrrolate, Formeterol fumarate, Precision, Accuracy, Linearity, HPLC.

An economic, uncomplicated, selective, detailed, and accurate RP-HPLC procedure for simultaneous quantitative

determination of glycopyrrolate and formeterol fumarate in combined dosage forms was validated according to ICH

guidelines. The method was developed using Shimadzu LC2010 CHT and Zorbax RX C18 (150x4.6mm ID) 3µm in

isocratic mode, with mobile phase comprising of Water: Acetonitrile: Methanol (20:30:50) the flow rate was 1.0

ml/min and the detection was carried at a wavelength of 279nm. The retention time and percentage assay of purity

for glycopyrrolate and formeterol fumarate was found to be 2.233 min and 3.224 min, 101.9% and 99.7%

respectively. The method was successfully validated for accuracy, precision, ruggedness, linearity and range,

specificity and robustness in accordance with ICH guidelines. The proposed method was found to be within the

acceptance limits indicating that the method is accurate, specific and economical.

Dimensions