Development of a Validated Stability-Indicating HPLC Method for Vinpocetine in the Presence of Potential Impurities in Tablet Dosage Form by Multiresponse Optimization.

Background: Vinpocetine has been prescribed for the treatment of ischemic brain diseases for many years. The drug, which has side effects such as headache, flushing, and decreased blood pressure, is not found in nature, but it can be synthesized by several approaches.

Objective: A simple, rapid, selective, stability-indicating high-performance liquid chromatographic (HPLC) method was developed for the simultaneous estimation of vinpocetine and their potential impurities in a tablet formulation.

Method: Optimum HPLC conditions were tried to be determined by a statistical experimental design method. The proposed method was validated as per the ICH guidelines. Stress study was used to demonstrate the stability-indicating ability of the developed method in the quantification of vinpocetine and potential impurities within the same run.

Results: According to multiresponse optimization using the Derringer's desirability function, the mobile phase consisted of an acetonitrile-phosphate buffer (pH 6.0) in the ratio of 65:35 (v/v) at a flow rate of 1.7 mL/min. Significant degradations were observed for the drug product under acid hydrolysis and alkali hydrolysis. The new method showed reasonable detection and quantification limits with good selectivity, precision, linearity, and recovery.

Conclusions: These validation results have shown that this method is suitable for quantitative determination of vinpocetine and its impurities in quality control laboratories.

Highlights: A reliable and rapid HPLC method optimized with response surface methodology and multiresponse optimization based on Derringer's desirability function was developed for the simultaneous analysis of vinpocetine and its impurities in a tablet formulation.