A comparative UV−HPLC analysis of ten brands of ibuprofen tablets (original) (raw)
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In-vitro evaluation of the pharmaceutical quality of some ibuprofen tablets dispensed in Nigeria
African Journal of …, 2009
The purpose of this study was to determine the pharmaceutical quality of some Ibuprofen tablets dispensed in Nigerian. 19 different brands of Ibuprofen tablets were purchased from pharmacies and open markets in 3 states in Nigeria. The organoleptic and physicochemical properties of these Ibuprofen tablets were assessed according to British Pharmacopoeia (BP), and unofficial standards as recommended by the manufacturers. Of the 19 brands of tablets assessed, 12 brands passed the uniformity of content test while 15 brands passed the disintegration test and only four brands passed the dissolution test. Ibuprofen tablets dispensed in Nigeria varied considerably in their pharmaceutical quality. A strict check of the quality of brands of Ibuprofen by regulatory agencies and distributors before they are dispensed to the public is therefore recommended.
Objective Quality of pharmaceutical products is required to guarantee their safety and efficacy. The aim of this study was to evaluate the physicochemical quality attributes of different brands of ibuprofen tablets marketed in Mekelle, Ethiopia. The methods stated in the British Pharmacopeia were adopted for weight uniformity, hardness, friability, disintegration test and assay of drug content. Dissolution test was also carried out as stated in the United States Pharmacopeia. To compare dissolution profile, statistical analysis of drug release at different time points were employed.Results All the brands were found with acceptable pharmacopeial specifications for weight uniformity, friability, hardness, assay of drug content and dissolution test. Six brands fulfilled the pharmacopeial requirements of disintegration test while one brand failed to disintegrate as per the BP specification. However, there were statistically significant difference in weight, hardness, disintegration, dis...
Journal of Applied Pharmaceutical Science, 2021
This study was carried out on the development of the RP-HPLC method and its application in the pharmaceutical equivalence study of ibuprofen tablets that are commercially available in the United Arab Emirates pharmaceutical markets. Three local and six imported brands of ibuprofen tablets were included in this study. The physical parameters of all products were recorded. An RP-HPLC system was developed and validated for the identification and quantification of the ibuprofen present within the tablets. The dissolution study was carried out using both UV-spectrophotometry (United State Pharmacopeia 42-National Formulary-37) and the RP-HPLC method with eight sampling data points. The dissolution profiles of eight test products were compared with a reference product (Switzerland), and similarity/ difference factors were calculated. The developed RP-HPLC method was simple, precise, and suitable for the quantification of ibuprofen present within the tablets. The studied products contained...
2017
This research provided quantitative data for the quality of randomly selected ibuprofen tablets that are sold in both formal and informal market in Harare, Zimbabwe. Fourteen batches of ibuprofen tablets comprising of sixty tablets per batch were randomly selected from retail pharmacies and informal traders over a period of six months. Quality control tests which included physical appearance, uniformity of mass, disintegration test, friability, in vitro dissolution test, spectrophotometric and High Performance Liquid Chromatography (HPLC) profiling of the samples were carried out. Three out of the fourteen batches failed the uniformity of mass test. Those that failed were from the informal market. One out of these also failed the quantitative chemical assay and dissolution test. Four other ibuprofen batches were according to labelling from the same manufacturer but had differences in the packaging used therefore raising suspicion of the possibility of counterfeiting. Two more ibupro...
2018
Dissolution testing has emerged as an essential quality-control tool to monitor batch-to-batch consistency during drug development. The aim of this study was to assess the dissolution performance of drug products containing ibuprofen as active pharmaceutical ingredient available on the Palestinian market. Ibuprofen is one of the most widely used analgesic, antipyretic and antiinflammatory over the counter (OTC) medication. Dissolution tests were performed using simulated intestinal fluid (pH 7.2) in accordance to the specifications in the United States Pharmacopoeia (USP). In vitro dissolution profiles of nine immediate-release ibuprofen formulations (A-I) were evaluated and compared. Percent of drug released was determined by spectrophotometric method. Comparison of dissolution profiles was done using similarity (f2) and difference (f1) factors. In the present work dissolution in basic media (7.2 phosphate buffer) was tested using a rotating paddle apparatus. The results obtained s...
A simple, selective and accurate thin layer chromatography (TLC)-densitometry method has been developed and validated for analysis of ibuprofen in pharmaceutical preparations. Ibuprofen assay was performed by TL-densitometry using silica gel 60 F254 plates as the stationary phase and a mixture of chloroform: methanol (10: 1) as the best mobile phase. Standard solution of ibuprofen in the range of 2-10 mg/mL resulted in a regression equation y = 14293.868 + 4201.72x with r = 0.9973. Ibuprofen detection limit was 0.88 mg/mL and the limit of quantification of ibuprofen was 2.70 mg/mL. Accuracy in generic ibuprofen tablets of PT Indo Farma and ibuprofen tablets under the trade name Proris® of PT Pharos had percent recovery range which meets 80-110 %. Precision intraday and interday had good repeatability as RSD ≤ 2 %. The analysis showed levels of ibuprofen on a generic tablet of 97.56 % ± 0.59 % and ibuprofen tablets under the trade name Proris® of 101.76 % ± 2.02 %. The levels ibuprofen obtained have suitably qualified Indonesian Pharmacopoeia edition V i.e. 90-110 %.
The East and Central African Journal of Pharmaceutical Sciences, 2009
The physicochemical equivalence of twenty-two brands of paracetamol and nine brands of ibuprofen tablets sourced from retail Pharmacy outlets in the Nigerian market to their respective innovator brands were investigated. The uniformity of weight, friability, crushing strength, disintegration and dissolution times and assay of active paracetamol ingredient were used as assessment parameters. All the brands of paracetamol and ibuprofen tablets complied with the official specifications for uniformity of weight. However, five brands of paracetamol failed the friability test, one brand of paracetamol and two brands of ibuprofen failed the disintegration test and three brands of paracetamol and four brands of ibuprofen failed the assay of active ingredients. The study shows that not all the brands of paracetamol and ibuprofen tablets are physico-chemically equivalent to their innovator brands. There is therefore the need for constant market surveillance to ascertain their compliance with official standards and equivalence to the innovator products.
Method Development for Visible Spectrophotometric Analysis of Ibuprofen in Pharmaceuticals
Ibuprofen is a prominent member of the group of non-steroidal anti-inflammatory drugs (NSAIDs), with good antiinflammatory action, a very effective analgesic, with increased antipyretic effect. The aim of this research was to exactly quantify pure Ibuprofen content in tablets of a pharmaceutical, by a spectrophotometric analysis method in the Visible range. Ibuprofen was quantitatively converted to a bright orange dye with a yellowish shade, by a color reaction with alphanaphthylamine in the presence of sodium nitrite, in an absolute ethanol medium. Following the analysis, it was found 397.952 milligrams of pure Ibuprofen content / film-coated tablet of the pharmaceutical product. This value was very close to Ibuprofen content declared by the pharmaceutical manufacturer (400 milligrams), with a mean deviation of only 0.512 percent from the officially declared amount of active substance. The value found fits perfectly within the normal limits provided by the European and International Pharmacopoeias standards, taken over by the Romanian Pharmacopoeia, 10th Edition. The spectrophotometric analysis method was then successfully subjected to statistical analysis.
Acta poloniae pharmaceutica
Solid-phase extraction method followed by direct UV spectrophotometry at 264 nm was developed and applied for the selective ibuprofen determination in two-component formulation of ibuprofen and pseudoephedrine-HCl, combined powder which contains ibuprofen in the form of salt with L-arginine and 10% ibuprofen cream. Procedures for ibuprofen determination in complex pharmaceutical preparations by direct UV spectrophotometry lack selectivity because of interferences of other active substances and fat components. A limited number of spectrophotometric methods applicable to these samples are based on derivative (first and second-order) UV spectroscopy. Common HPLC procedures are more selective but more expensive and for creams also require some type of extraction because the large amount of oily excipients would clog up the column. The proposed solid-phase extraction method proved to be suitable for analysis of ibuprofen in combined tablets, powders and creams by direct UV spectrophotome...