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Development and Validation of a Stability-Indicating Chromatographic Method for the Determination of Indacaterol Maleate with Glycopyrronium Bromide in Mixture

Author(s):

Sonia Hassib, Hanaa Hashem, Marwa Fouad* and Nehal Mohamed   Pages 1 - 9 ( 9 )

Abstract:


Method: An easy, precise and selective reversed-phase liquid chromatographic method, with stability-indicating assay was established and validated for the determination of indacaterol maleate and glycopyrronium bromide in the mixture. In addition, a forced degradation study was performed for indacaterol maleate, comprised of hydrolysis by acid and base, degradation by oxidation and heat, and photo-degradation. Separation and forced degradation were done by isocratic elution using a reversed phase phenyl column and (methanol: phosphate buffer) at ratio (65:35, v/v) with 3.5 pH buffer as an eluent at 1 mL min-1 as a flow rate. Quantitation was accomplished using a UV detector at 210 nm. Results: The method showed good separation of glycopyrronium bromide, indacaterol maleate and its degradation products. Accuracy, linearity, and precision were acceptable over 10–160 μg mL-1 and 10– 80 μg mL-1 concentration range for indacaterol maleate and glycopyrronium bromide, respectively. Conclusion: The proposed method does not require any previously done separation steps, making it applicable for the analysis of the drugs under investigation in their pharmaceutically marketed preparations.

Keywords:

Indacaterol maleate, Glycopyrronium bromide, HPLC, Forced degradation.

Affiliation:

Faculty of Pharmacy, Cairo University, Pharmaceutical Chemistry, Kasr Eleini street, Faculty of Pharmacy, Cairo University, Pharmaceutical Chemistry, Kasr Eleini street, Faculty of Pharmacy, Cairo University, Kasr Eleini street, Faculty of Pharmacy, Cairo University, Pharmaceutical Chemistry, Kasr Eleini street



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