Abstract

Objective: This study evaluates the registration status and the quality of nine brands of Vitamin C sold in Freetown, Sierra Leone, using official and non-official methods of analysis. Methods: The parameters taken into consideration during the study include non-official methods (friability and disintegration) and the official methods (identification test, uniformity of dosage unit, and assay by titrimetric and colorimetric tests). The different brands of vitamin C were selected and classified as registered and unregistered based on the data derived from the National Medicines Regulatory Authority. Results: One vitamin C product collected was unregistered at the National medicines regulatory authority (Pharmacy Board of Sierra Leone). All nine vitamin C products met the requirements for uniformity of dosage unit. The vitamin C products also conformed to the BP specification for friability and identification test (retention factor). The identification test showed that each brand contained vitamin C (ascorbic acid). The disintegration test was not applicable for chewable tablets. Three of the four non-chewable vitamin C products complied with the BP specification for disintegration, while one failed and did not meet the requirement. The assay results for ascorbic acid using titration and colourimetric method were comparable and appropriate for determining vitamin C. Out of a total of nine samples; seven met the requirement for BP specification (Passed) for assay. In contrast, one product did not meet the BP requirement (failed), and one sample had more vitamin C than the Pharmacopoeia limit. Conclusion: Periodic quality evaluation and routine checks for pharmaceutical products can ascertain the quality of products, their storage conditions and identify potential counterfeit medications.

Highlights

  • Vitamin C or L-ascorbate is a water-soluble vitamin

  • This study evaluates the different brands of vitamin C in Freetown using the following methods: thin layer chromatography test, uniformity of dosage unit, assay to determine the content of active pharmaceutical ingredients in the pharmaceutical tablet, colourimetric method, friability, and disintegration test [8]

  • The sample profile in table 1 describes the different brands of Vitamin C based on packaging, manufacturing country, storage condition, and the strength of ascorbic acid used

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Summary

Introduction

Vitamin C or L-ascorbate is a water-soluble vitamin. It is a vital antioxidant that plays an essential role in human nutrition [1]. It acts as a cofactor for some biologically active radicals. Vitamin C is necessary for building blood vessels, ligaments, tendons, bones and is essential in synthesising carnitine, which is involved in metabolism in most plants and some bacteria [1, 2]. WHO suggested that most drugs in the world today are either falsified or substandard and that 10% are from low and middleincome countries. Substandard medicines may come from poor manufacturing and quality assurance processes and reach the public due to lax control measures, whereas falsified medicines are deliberately and fraudulently labelled [3]

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