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


Karaer Ö., Dinç Zor Ş., Aşçı B.

Journal Of Aoac International, vol.1, no.1, pp.1-6, 2021 (Peer-Reviewed Journal)

  • Publication Type: Article / Article
  • Volume: 1 Issue: 1
  • Publication Date: 2021
  • Doi Number: 10.1093/jaoacint/qsab167
  • Journal Name: Journal Of Aoac International
  • Journal Indexes: Science Citation Index Expanded, Scopus, Academic Search Premier, Applied Science & Technology Source, BIOSIS, CAB Abstracts, Chemical Abstracts Core, Chimica, Compendex, EMBASE, Food Science & Technology Abstracts, MEDLINE, Veterinary Science Database, DIALNET
  • Page Numbers: pp.1-6

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.