GREEN VALIDATED METHOD FOR DETERMINATION OF TIMONIUM METHYL SULPHATE USING RP-HPLC TECHNIQUE WITH STABILITY-INDICATING STUDIES

Abstract

Abstract

   Objective:  The objective of this method was to develop a  simple, sensitive, rapid

 reversed phase high-performance liquid chromatography (RP-HPLC) and applied for determination of Tiemonium methyl sulphate (TIM) in bulk , pharmaceutical formulations with stability indicating studies.

 

 

 Methods: The stability-indicating capability of this method had been established by subjected TIM  to several stress conditions of acidic, basic, oxidative, freezing, heating ,photolytic and catalytic degradation 

Results: good separation between the target analyte and its degradation products without any interference referring to specificity and selectivity of this method had been reported. Reversed-phase C₁₈ Kinetex^® column( 100 x 4.6 mm I.D., 2.6μm ) , isocratic mobile phase composed of an aqueous solution adjusted to pH 2.3 by 0.1% orthophosphoric acid–acetonitrile (80:20, v/v) at 0.8 ml/min flow rate were used. The assay showed good linearity over the concentration range of 1-25 μg/ml  with correlation of coefficient >0.999 and with a detection limit of 0.249 μg/ml and a quantitation limit of 0.755 μg/ml  .Results of the analysis were validated statistically by recovery studies.

Conclusion: validated stability-indicating RP-HPLC has been developed for estimation of TIM in its pure and commercial forms in addition to good separation from its degradation products within reasonable time

 

 

 Key words: Tiemonium methyl sulphate, RP-HPLC, stability-indicating.