Validated gradient Stability-Indicating UPLC Method for the Determination of Lidocaine and its Degradation Impurities in Pharmaceutical Dosage Form
Objective: Aim of the present work was to develop a stability indicating ultra performance liquid chromatography (UPLC) method to determine Lidocaine and its degradation impurities in pharmaceutical dosage forms.
Method: Chromatographic separation was achieved by gradient elution on Agilent eclipse plus C18 (100x4.6) mm, and 1.8m column with potassium dihydrogen phosphate buffer (pH 4.50) and acetonitrile within a short runtime of 14.0 min. The eluted compounds were monitored at 230 nm using photodiode array (PDA) detector, the flow rate was 1.0 mL/min, and the column oven temperature was maintained at 40 ?C.
Result: The resolution of Lidocaine and six (potential, bi-products and degradation) impurities was greater than 2.0 for all pairs of components. The repeatability and intermediate precision, expressed by the RSD, were less than 1.0%. The accuracy and validity of the method were further ascertained by performing recovery studies. The specificity of the method was investigated under different stress conditions including hydrolytic, oxidative, photolytic and thermal as recommended by ICH guidelines. Relevant degradation was found to take place under oxidative condition.
Conclusion: Method was Robustness against small modification in pH, column oven temperature, flow rate and percentage of the mobile phase composition was ascertained. All these results provide that the method has stability indicating properties being fit for its intended purpose; it may find application for the routine analysis of the related substances of Lidocaine formulations.
Copyright (c) 2014 International Journal of Advances in Pharmaceutical Analysis
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish with this journal agree to the following terms:
a) Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution License that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
b)Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
c) Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).
After acceptance of the article, the author has to submit copyright form signed by all authors.