High-Performance Liquid Chromatographic Determination of Folic Acid Content in Pharmaceutical Formulations marketed in Southwest Nigeria.
Keywords:Folic acid, physicochemical properties, assay of content, labelled claim, RP-HPLC, validation
Background Folic acid is presented as tablets and syrups or incorporated into food, drinks, and beverages frequently for fortification as a remedy to folic acid deficiency which may cause severe health consequences. Consequently, the analysis of folate in pharmaceutical preparations by quantitative methods like high-performance liquid chromatographic (HPLC) in this study cannot be overemphasized
Methods: The parameters investigated included weight uniformity, hardness, friability, and disintegration rate. A validated, reversed-phase HPLC (RP-HPLC) method ran with trifluoroacetic acid and acetonitrile (90:10) as mobile phase, on a C18 column, at 40°C, was used to assay the content. The method employed a flow rate of 1.0 mL/min and a wavelength of 290 nm. The injection volume was 10 µL
Results: The weight of the tablets ranged between 9.86±0.01-32.30±0.01 mg, hardness was 7.52±0.80-15.48±1.53 kg/cm3, and tablets' friability was less than 1%. All the tablets passed the disintegration test for uncoated tablets except FAJ. Folic acid was eluted at 2.616 min and the RPHPLC method displayed good linearity over the concentration range of 5-200 ppm, with a correlation coefficient (r2) of 0.9998. The relative standard deviation (% RSD) for precision was 0.2%, while the LOD and LOQ values were 1.3191 and 4.3969 µg/ml respectively. The % RSD for reproducibility was < 5% in the assay of folic acid tablet samples. Only 50% of the brands passed the assay of content i.e., fell within the specified range of not less than 90 % and not more than 110 % according to reference specification
Conclusion: None of the brands of folic acid tablets evaluated complied with all the specifications for each test carried out whether compendia or non-compendia test. Hence, stringent quality control including adequate storage control should be applied for the release of such vitamin preparations.
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