Estimation of Glycopyrrolate by Analytical Quality by Design Supported Difference UV Spectrophotometric Method
DOI:
https://doi.org/10.37285/ijpsn.2018.11.5.4Abstract
A novel difference UV spectrophotometric method was developed and validated for estimation of glycopyrrolate (GLP) in injection formulations using analytical quality by design approach. GLP shows two different absorbance maxima in 0.1M HCl and 0.1M NaOH. Principle of difference spectroscopy was utilized to avoid the variation in absorbance maximum and amplitude of analyte solutions were measured keeping analyte in 0.1M HCl in reference cell and analyte in 0.1M NaOH in sample cell. The amplitude was measured considering maxima at 219nm and minima at 233nm. Further, analytical quality by design approach proved worthy by ensuring method robustness prior to method development. Scanning speed and sampling interval were the two variables which were studied for the robustness purpose using an experimental design. The method validation studies were carried out to evaluate linearity, accuracy, precision, sensitivity etc. The method was applied successfully for estimation of GLP in bulk and present in injections.
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Keywords:
Glycopyrrolate, Difference spectrophotometry, Quality by design, Robustness
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Dwivedi J, Patel D, Patel K and Meshram D (2017). Development and validation of first order derivative spectrophotometry for simultaneous determination of indacaterol maleate and glycopyrronium bromide in pharmaceutical dosage form. International Journal of Research in Pharmacy and Biosciences 4: 12-18.
Evatt ML (2011). Oral glycopyrrolate for the treatment of chronic severe drooling caused by neurological disorders in children. Neuropsychiatr Dis Treat 7: 543-547.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2009). Pharmaceutical Development, Parent guidelines on Pharmaceutical Development Q8 (R2), Harmonized Tripartite Guideline, Geneva, Switzerland.
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (2005). Guideline on Validation of Analytical Procedures: Text and Methodology Q2 (R1), Harmonized Tripartite Guideline, Geneva, Switzerland.
O’Neil MJ ed. The Merck Index, 14th ed., NJ: USA, Merck Research Laboratories, Merck & Co., Inc., Whitehouse Station, 2006, 777.
Panda SS, Ravi Kumar BVV, Beg S and Sahu SK (2015). Ultrafast liquid chromatographic method development and its validation for quantification of telaprevir in pharmaceutical dosage form by using quality by design approach. J Chromatogr Sci 53: 1193-1202.
Panda SS, Beg S, Ravi Kumar BVV and Singh P (2015). Analytical quality-by-design compliant ultrafast liquid chromatographic method for determination of paliperidone in extended release tablet dosage form. J Bioanal Biomed 7: 116-123.
Panda SS, Beg S, Bera VVRK and Gain A (2017). Spectro-photometric determination of sertaconazole nitrate in pharmaceutical dosage form using quality by design framework. J Bioanal Biomed 9: 235-239.
