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

Abstract

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. Objectives A simple, rapid, selective, stability-indicating high performance liquid chromatographic method was developed for the simultaneous estimation of vinpocetine and their potential impurities in a tablet formulation. Methods Optimum HPLC conditions were tried to be determined by 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 multi-response optimization using the Derringer’s desirability function, the mobile phase consisted of acetonitrile: Phosphate Buffer (pH 6.0) in the ratio of 65:35 ʋ/ʋ 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 which was optimized with response surface methodology and multi-response optimization based on Derringer’s desirability function was developed for the simultaneous analysis of vinpocetine and its impurities in a tablet formulation.

The role of Phosphodiesterase-1 and its natural product inhibitors in Alzheimer’s disease: A review

“…To date, reductions in synapses and neuronal injury are presumed to account for the decrease in neuroplasticity and increase in cognitive decline (Figure 4) (Heckman et al, 2014). Vinpocetine, a classical selective inhibitor of PDE1 (Heckman et al, 2017), is a dehydrated and semisynthetic derivative of the alkaloid vincamine derived from the family Apocynaceae, in which methyl ester is replaced with an ethyl ester (Al-Kuraishy et al, 2020;Karaer et al, 2022). Vinpocetine has been found to be more active than vincamine (Figure 5).…”

“…Vinpocetine is less soluble in water and more soluble in nonpolar vehicles (Ahad et al, 2022). Various clinical studies have proven the neuroprotective effects of vinpocetine (Karaer (Karaer et al, 2022) and marketed under the brand name Cavinton (Dubey et al, 2020). It has been extensively prescribed since.…”

“…Vinpocetine, a classical selective inhibitor of PDE1 ( Heckman et al, 2017 ), is a dehydrated and semisynthetic derivative of the alkaloid vincamine derived from the family Apocynaceae, in which methyl ester is replaced with an ethyl ester ( Al-Kuraishy et al, 2020 ; Karaer et al, 2022 ). Vinpocetine has been found to be more active than vincamine ( Figure 5 ).…”

“…Vinpocetine has been found to be more active than vincamine ( Figure 5 ). Vinpocetine crosses the blood–brain–barrier (BBB) and enters the brain after oral or intravenous administration ( Karaer et al, 2022 ). Vinpocetine is less soluble in water and more soluble in nonpolar vehicles ( Ahad et al, 2022 ).…”

“…Vinpocetine is less soluble in water and more soluble in nonpolar vehicles ( Ahad et al, 2022 ). Various clinical studies have proven the neuroprotective effects of vinpocetine ( Karaer et al, 2022 ). Vinpocetine was developed and launched for the first time in Hungary in 1978 ( Karaer et al, 2022 ) and marketed under the brand name Cavinton ( Dubey et al, 2020 ).…”