Simple and Rapid Method Development for Glycopyrrolate Injection Using High-Performance Liquid Chromatography (HPLC)

Abstract

The main aim of the present work is to develop a simple and rapid method for determining the impurity profile of related substances in glycopyrrolate from glycopyrrolate injection using high-performance liquid chromatography (HPLC). This method makes use of the C8 (Kromasil 100 250 mm x 4.6mm, 5μ) particle size column for rapid separation of related substances of glycopyrrolate from glycopyrrolate injection along with the related substances using ultraviolet and photodiode array detectors (UV/PDA), pH2.9±0.05 potassium dihydrogen phosphate buffer solution with the column temperature was 45°C, the gradient elution mode, and the wavelength of detection was 222 nm. The procedure was tested in order to prove its efficacy for the intended use. In the case of glycopyrrolate, peak responses were shown to be linear throughout impurity values of 0.05 to 0.75 ppm. For glycopyrrolate, the correlation coefficient was found to be 0.999. This method will be beneficial for determining the impurity profile of glycopyrrolate-related compounds in the injection dosage form of glycopyrrolate. The sample and standard solutions are found to be stable at refrigerator temperature for up to 48 h, while the standard solution is found to be stable on the bench-top for up to 48 h. The results for specificity (degradation), precision, accuracy, LOD, LOQ, and robustness were determined to be satisfactory. The method is simple, rapid, and selective; the described method is precise for estimation of related substances in glycopyrrolate injection. Our results demonstrated that the developed method warrants further development for use in the pharmaceutical industry, such as regular quality control analysis.