Analytical Method Validation of HPLC Method for Assay of Anticholinergic Drug in Parenteral Formulation

Author(s)

Mishra, S., Arora, V.

Author's Affiliation

Abstract

A novel, accurate and precise HPLC method for determination of assay of Anti-cholinergic drug has been validated. Separation was achieved on Inertsil ODS-3, 3µm using Buffer:ACN:Methanol as mobile phase at a flow rate of 1.2 ml/min and UV detection at 222 nm. The developed method was applied for determination of assay of Anticholinergic drug in Parenteral formulation and the method was validated with respect to Specificity, Precision, Linearity, Accuracy, Robustness and analytical   solution   stability. The   method   was linear over the range   of   60-140 µg/ml for Glycopyrrolate.  The   mean   recovery was found to be in the range of   99.12-99.73 %. The percentage of   relative standard deviation was found to be less than critical value. The method was found to be accurate, precise and selective for simultaneous estimation of Glycopyrrolate in injections.

Keywords

Glycopyrrolate, Reverse-phase HPLC, Method Validation

Cite This Article

Mishra, S., Arora, V. (2016). Analytical Method Validation of HPLC Method for Assay of Anticholinergic Drug in Parenteral Formulation, International Journal for Pharmaceutical Research Scholars (IJPRS), 5(4), 101-104.