Folic acid tablets: dissolution – method development and validation (original) (raw)
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International Journal of Pharmacy and Pharmaceutical Sciences, 2015
Objectives: Folic acid is a water-soluble B vitamin that is naturally present in some foods such as dark green leafy vegetables and dairy products, added to others such as fortified breads, and available as a dietary supplement. In a study performed in the United States, out of nine multivitamin products, only three products met US Pharmacopeia (USP) standard for folic acid dissolution. The aim of this study is to evaluate the dissolution profile of folic acid supplements in the United Arab Emirates according to the USP standards. Methods: Two commercial brands were collected from the market that are commonly prescribed. Water and citrate buffer (pH 6.0) were used as dissolution media. Results: Both products passed the dissolution testing of releasing the required amount of drug substance (75%) within 60 minutes. Also, both products contain an over age of up to 150% of the labeled amount to ensure the availability of the claimed amount. Conclusion: The study indicates that dissolution test is well established, reproducible, reliable and valuable tool for characterizing a drug product at different stages in its lifecycle. The use of citrate buffer showed a significant change in the release of folic acid from the tablets.
In Vitro Evaluation of Dissolution Profile of Two Commercially Available Folic Acid Preparations
International Journal of Pharmacy and Pharmaceutical Sciences, 2015
Objectives: Folic acid is a water-soluble B vitamin that is naturally present in some foods such as dark green leafy vegetables and dairy products, added to others such as fortified breads, and available as a dietary supplement. In a study performed in the United States, out of nine multivitamin products, only three products met US Pharmacopeia (USP) standard for folic acid dissolution. The aim of this study is to evaluate the dissolution profile of folic acid supplements in the United Arab Emirates according to the USP standards. Methods : Two commercial brands were collected from the market that are commonly prescribed. Water and citrate buffer (pH 6.0) were used as dissolution media. Results : Both products passed the dissolution testing of releasing the required amount of drug substance (75%) within 60 minutes. Also, both products contain an over age of up to 150% of the labeled amount to ensure the availability of the claimed amount. Conclusion : The study indicates that dissol...
Influence of pH on the dissolution of folic acid supplements
International Journal of Pharmaceutics, 2009
The vitamin folic acid has received considerable attention because of its role in decreasing the risk of neural tube birth defects, and its potential role in reducing the risks of cardiovascular and psychiatric diseases. A significant concern is the quality of commercially available folic acid products. We evaluated the pharmaceutical performance of 15 currently available folic acid products in terms of meeting the USP standards for disintegration and dissolution, and showed that there has been significant improvement in the past decade in the quality of these products. However, at least one product failed to meet the requirement of each test performed. Since folic acid absorption is maximal at the proximal jejunum, dissolution was further evaluated in simulated gastric fluid. All the products failed to release more than 75% of the active ingredient in 60 min. While some excipient-related factors were preliminarily considered, it was ultimately proposed that the failure may be related to the pH-dependency of the solubility of folic acid, a premise supported by faster dissolution of laboratory prepared buffered folic acid tablets. The more limited solubility of folic acid in acidic medium should be taken into consideration in the required dissolution testing methods, as well as in product formulation to optimize release.
Estimation of the Folic Acid Using Zero Order, Area Under Curve and First Derivative Spectrophotometric Methods in Pure and Marketed Tablet Formulations, 2017
Three simple, inexpensive and nontoxic spectrophotometric methods have been used for determination folic acid in pure and market formulation tablets. Linearity was founded in the range 6- 20 mg.l-1 for the all three methods, the detection limits was found to be 0.261 for zero order method, 0.006 for AUC method and 3.800 for first derivative method. The RSD% was found to be less than 0.856 indicating a good accuracy and precision of three proposed methods. The results of zero order, AUC and first derivative methods were statistically compared with those obtained by the official standard method using the F-test and t-test and found to be a good agreement. [DOI: 10.22401/JUNS.20.3.07]
Physicochemical, Pharmacological and Analytical Profile of Folic Acid: A Comprehensive Review
International Research Journal Of Pharmacy
The importance of folic acid can be felt from the fact that it is required by a female since she plans for pregnancy. It is requiring 1 to 1.5 fold by a pregnant lady that is required by an adult person. Folic acid is needed by a person daily to undergo vital body function like hindrance in cycle, synthesis of DNA, RBC production etc. Deficiency of folic acid may lead to a severe complication like neural tube defects, megaloblastic anemia, malignancy and pregnancy complications. The present review summaries the physicochemical properties, biological action, pharmacological effect, therapeutic potential and analytical methods of folic acid. The recent researches on folic acid in the pharmaceutical field have also been discussed.
Macedonian Pharmaceutical Bulletin
The vitamin folic acid has received considerable attention because of it′s role in decreasing risk of neural tube birth defects, and it′s potential role in reducing risks of cardiovascular and psychiatric diseases. We evaluated compositions of 5 different formulations in terms of meeting the USP standard for dissolution and disintegration .However all the examined formulations had met the disintegration test but only 3 formulations had met the dissolution requirements to release 75 % of the active ingredient in 45 minutes. The maximum value of dissolution of 97.52 % in S5 composition was achieved by combination of certain excipients (combination of hydrophilic and hydrophobic filler and suitable wetting agent) and wet high shear mixing granulation technique, resulting with optimize release of the active substance.
A Thin Layer Chromatography Densitometric Method for Assay of Folic Acid in Tablets
The East and Central African Journal of Pharmaceutical Sciences, 2015
A High Performance Thin Layer Chromatography (HPTLC) method for analysis of folic acid was developed and validated according to ICH and USP guidelines. The developed method was used for simultaneous qualitative and quantitative analysis of folic acid in tablets. The method was developed using an environmentally friendly mobile phase containing ethyl acetate:methanol:ammonia solution (15:15:0.5 v/v/v) on pre-coated HPTLC silica gel 60 F 254 glass plates at a detection wavelength of 280 nm using reflectance absorbance and saturation time of 25 min. Densitometric analysis showed two folic acid products being retained at R f of 0.27 and 0.67 and the area was taken as the sum of the two. The method was specific and no interferences were observed between folic acid peaks and that of the excipients. The calibration curve of folic acid was constructed using both linear and polynomial regression function in the range of 317.19-761.25 ng/spot both with regression coefficient, r 2 of 0.998. The accuracy at nominal concentration of folic acid was found to be 101.05%, % rsd, repeatability and intermediate precision were found to be 1.79% and 1.93 respectively. The developed method is thus simple, accurate, and cost effective with good precision and repeatability for the assay of folic acid in tablets which will be particularly useful in resource constrained countries.
Qualitative and Quantitative Determination of Folic acid in Tablets by FTIR Spectroscopy
Qualitative and quantitative determination of chemicals especially that deal with drugs and pharmaceuticals can be considered as important issues in scientific research to insure human safety and security. With this direction of scientific research, folic acid had been determined qualitatively and quantitatively through applying FTIR technique. By applying a weight range of the pure compound, the obtained results showed several absorption peaks with standard curves that obeyed Lambert-Beer Law. Also, HPLC technique applied and compared with FTIR of different pharmaceuticals in local Iraqi market. The relative percentage error (E%) and Recovery percentage (Rec. %) results for both methods proved that sampling procedure in FTIR technique for both pure and pharmaceutical samples was more superiority beside simplicity.
The Pharma Innovation Journal, 2023
Folic acid, or vitamin B9, is one of the crucial vitamins. The body requires folic acid in a smaller amount, even though it plays an important role during pregnancy. This led to fortification in cereals and grains and folic acid supplementation was started. Several methods are available to determine folic acid in food samples and in drugs. UV spectrometry and TLC are very simple and convenient to use; there is no need for a skilled person. In UV spectrometry, folic acid standards were observed with phosphate buffer saline and water. The wavelength detected for phosphate buffer saline was 281nm and for water, 280nm. The fruits were also analyzed, apples and black dried grapes both fruits formed good chromatograms at 280nm and 281 nm, respectively. In Thin layer chromatography, folic acid standards with different combinations of solvents and chemicals formed bands, but in the majority, TLC formed smudges. UV and TLC support the synthesized form of folic acid, not the naturally occurring forms of folate. Phosphate buffer and water are good options for extracting, but there are still many more separation techniques needed.
Analytical Biochemistry, 2002
Novel coupling reagents are used for the simple and sensitive spectrophotometric determination of folic acid either in pure form or in its pharmaceutical preparations. The methods are based on the probable diazotization of the p-aminobenzoylglutamic acid obtained after reductive clevage of folic acid, followed by either coupling with iminodibenzyl to give a violet product with k max of 580 nm or coupling with 3-aminophenol to produce an orange yellow-colored product with k max of 460 nm. Sodium molybdate and pyrocatechol are used in the third method and the pale red-colored product formed has a k max of 490 nm. The methods are highly reproducible and have been applied to the determination of folic acid in tablets and the results compare favorably with the official method. Common excipients used as additives in pharmaceutical preparations do not interfere in the proposed methods. Ó 2002 Elsevier Science (USA). All rights reserved.