Abstract

CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION STABILITY-INDICATING TWO IMPURITIES AND ITS DEGRADATION PRODUCTS IN PYRIDOSTIGMINE BROMIDE ORAL SOLUTION, 60 MG/5 ML

*Naresh Chandra Reddy Male and Kavitha Male

Abstract

A Novel RPHPLC Quantification method was developed for estimation of Pyridostigmine known impurities like its Hydroxy NMethyl Impurity, Pyridine Dimethyl Carbamate Impurity which, were separated on Phenomenex Kinetex C18 column (150 mm x 4.6 mm; 5μ). Using a mixture of Phosphate Monobasic, 1.74 g of Potassium Phosphate Dibasic and 2.16 g of 1-Octane Sulfonic Acid Sodium Salt Anhydrous, Acetonitrile as a gradient mobile phase with a flow rate of 1.0 ml/min; λ max at 220 nm. The developed method was validated all the parameters like linearity, specificity, LOD, LOQ, accuracy, robustness, ruggedness , precision, filter variation, solution stability and forced degradation studies.

Keywords: Method development and validation, Pyridostigmine, Related substances, Stability-indicating.