Simultaneous spectrophotometric determination of indacaterol and glycopyrronium in a newly approved pharmaceutical formulation using different signal processing techniques of ratio spectra

• First spectrophotometric methods for indacaterol and glycopyrronium simultaneous determination without prior separation.
• The proposed methods were successfully applied to the analysis of the two drugs in a newly approved dosage form.
• The proposed methods are based on different signal processing techniques of ratio spectra.
• ICH guidelines were applied for validation of the proposed methods.
• The proposed methods can be used in routine QC with excellent accuracy and precision.

Three spectrophotometric methods have been developed and validated for determination of indacaterol (IND) and glycopyrronium (GLY) in their binary mixtures and novel pharmaceutical dosage form. The proposed methods are considered to be the first methods to determine the investigated drugs simultaneously. The developed methods are based on different signal processing techniques of ratio spectra namely; Numerical Differentiation (ND), Savitsky–Golay (SG) and Fourier Transform (FT). The developed methods showed linearity over concentration range 1–30 and 10–35 (μg/mL) for IND and GLY, respectively. The accuracy calculated as percentage recoveries were in the range of 99.00%–100.49% with low value of RSD% (< 1.5%) demonstrating an excellent accuracy of the proposed methods. The developed methods were proved to be specific, sensitive and precise for quality control of the investigated drugs in their pharmaceutical dosage form without the need for any separation process.

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