The Simultaneous Determination of Ibuprofen and Paracetamol in Pharmaceutical Formulations by High‑performance Liquid Chromatography with Ultraviolet Detection (original) (raw)
Related papers
A simple and fast isocratic Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed and validated for the simultaneous determination of Paracetamol and Ibuprofen in tablets. The method consists of a mobile phase combination of Methanol (HPLC grade) and 0.025 M phosphate buffer adjusted to pH 3.0 with orthophosphoric acid in the ratio 80:20 using Eurospher 100-5 C18 (250 x 4.6) mm (Knauer Column with precolumn) as the stationary phase. The flow rate was 1.0 mL/min at ambient temperature conditions. With Caffeine as the internal standard, quantification was achieved with UV detection at 225 nm. A good resolution and a short run time of 12 minutes were achieved with the validated conditions. The retention times of Paracetamol, Ibuprofen and Caffeine were 2.864±0.005, 4.011±0.006 and 7.678±0.007 respectively. The method was found to be specific, robust, accurate and precise for the estimation of Paracetamol and Ibuprofen in Paracetamol and Ibuprofen fixed dose tablets over the concentration ranges of 0.00584 % w/v-0.00876 % w/v and 0.00709 % w/v-0.001063 % w/v respectively. The Correlation Coefficient (r 2) for Paracetamol and Ibuprofen were greater than 0.999. The purpose of this study was to develop and validate a simple HPLC method for the estimation of Paracetamol and Ibuprofen in combined dosage forms. The proposed method is precise, specific, accurate and robust for the simultaneous estimation of Paracetamol and Ibuprofen in dosage forms.
A simple and fast isocratic Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed and validated for the simultaneous determination of Paracetamol and Ibuprofen in tablets. The method consists of a mobile phase combination of Methanol (HPLC grade) and 0.025 M phosphate buffer adjusted to pH 3.0 with orthophosphoric acid in the ratio 80:20 using Eurospher 100-5 C18 (250 x 4.6) mm (Knauer Column with precolumn) as the stationary phase. The flow rate was 1.0 mL/min at ambient temperature conditions. With Caffeine as the internal standard, quantification was achieved with UV detection at 225 nm. A good resolution and a short run time of 12 minutes were achieved with the validated conditions. The retention times of Paracetamol, Ibuprofen and Caffeine were 2.864±0.005, 4.011±0.006 and 7.678±0.007 respectively. The method was found to be specific, robust, accurate and precise for the estimation of Paracetamol and Ibuprofen in Paracetamol and Ibuprofen fixed dose tablets over the concentration ranges of 0.00584 % w/v -0.00876 % w/v and 0.00709 % w/v -0.001063 % w/v respectively. The Correlation Coefficient (r 2 ) for Paracetamol and Ibuprofen were greater than 0.999. The purpose of this study was to develop and validate a simple HPLC method for the estimation of Paracetamol and Ibuprofen in combined dosage forms. The proposed method is precise, specific, accurate and robust for the simultaneous estimation of Paracetamol and Ibuprofen in dosage forms.
A rapid and stability-indicating reversed phase high-performance liquid chromatography (RP-HPLC) method was developed for simultaneous quantification of paracetamol and ibuprofen in their combined dosage form especially to get some more advantages over other methods already developed for this combination. The method was validated according to United States Pharmacopeia (USP) guideline with respect to accuracy, precision, specificity, linearity, solution stability, robustness, sensitivity, and system suitability. Forced degradation study was validated according to International Conference on Harmonisation (ICH). For this, an isocratic condition of mobile phase comprising phosphate buffer (pH 6.8) and acetonitrile in a ratio of 65:35, v/v at a flow rate of 0.7 mL/minute over RP C18 (octadecylsilane (ODS), 150 × 4.6 mm, 5 μm, Phenomenex Inc.) column at ambient temperature was maintained. The method showed excellent linear response with correlation coefficient (R2) values of 0.999 and 1.0 for paracetamol and ibuprofen respectively, which were within the limit of correlation coefficient (R2 0.995). The percent recoveries for two drugs were found within the acceptance limit of (97.0–103.0%). Intraand inter-day precision studies of the new method were less than the maximum allowable limit percentage of relative standard deviation (%RSD) 2.0. Forced degradation of the drug product was carried out as per the ICH guidelines with a view to establishing the stability-indicating property of this method and providing useful information about the degradation pathways, degradation products, and how the quality of a drug substance and drug product changes with time under the influence of various stressing conditions. The degradation of ibuprofen was within the limit (5–20%, according to the guideline of ICH), while paracetamol showed 20% degradation in oxidation and basic condition.
2012
In this study, high performance liquid chromatographic method have been developed and validated for the simultaneous determination of Paracetamol and Ibuprofen in combined pharmaceutical formulations. The chromatography was carried out on a C 18 (250 mm x 4.6 mm, 10 µm) column with methanol and 0.05 M sodium dihydrogen phosphate (65:35 v/v) as mobile phase, at a flow rate of 1.0 ml/min, with detection at 230 nm. Separation was complete in less than 8 min. The calibration curves were linear in the concentration range of 50.00-400.0 µg/ml for paracetamol and 20.00-160.0 µg/ml for ibuprofen. The % recovery for paracetamol and ibuprofen is in the range between 99.53 and 99.83 with RSD values not greater than 0.62. The results of the studies showed that the proposed RP-HPLC method is simple, rapid, precise and accurate, which can be applied for the routine assessment of paracetamol and ibuprofen in pharmaceutical dosage forms.
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...
A very simple and sensitive Spectrophotmetric method for simultaneous kinetic determination of paracetamol and ibuprofen using H-point standard addition method (HPSAM) was described. The method was based on difference in the rate of oxidation of these compounds with alkaline potassium permanganate to produce a bluish green colored measurable at 610 nm. Different experimental parameters were carefully studied and optimized for getting results with minimum errors. Paracetamol and ibuprofen can be determined in the range of 1.0-20.0 and 5.0-25.0 µgm1-1 respectively and minimum detectability of 0.29 and 0.92 µgm1-1. Correlation coefficients were greater than 0.9971 in all cases. The maximum value of relative standard deviation did not exceed 1.25 (n=5). The recovery was between 98.0 to 101.2% with relative error of 0.09 and 0.1 for paracetamol and ibuprofen, respectively. The proposed method has successfully been applied for simultaneous determination of paracetamol and ibuprofen in syn...
Separations
A simple analytical approach based on capillary zone electrophoresis with ultraviolet detection and repeated sample injection strategy (applied in a hydrodynamically closed separation system for the first time) was developed for the determination of ibuprofen (IBU) in commercially available pharmaceutical preparations. The proposed method was characterized by significantly increased sample throughput and favorable validation parameters, highly demanded in routine quality control laboratories. The limit of detection was predicted at the concentration level of 0.31 µg/mL. Intra-day precision expressed as the relative standard deviation of IBU concentration ranged from 1.9 to 5.6%, and corresponding intra-day accuracy expressed as the relative error was in the interval of 87.1–106.5%. Inter-day precision was in the range of 2.6–15.0%, and inter-day accuracy was 94.9–102.7%. The developed method was able to quantify IBU in complex pharmaceutical matrices represented by commercially avai...
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.
The proposed work describes the development and validation of a simple, precise and accurate method for the combination tablet formulation of Paracetamol and Ibuprofen by UPLC. Efficient separations of the Paracetamol and Ibuprofen were achieved in < 3 min by an isocratic elution with 20mM potassium dihydrogen phosphate buffer (pH 7.35 with dilute ortho phosphoric acid): acetonitrile (35:65 v/v) mobile phase at a flow rate of 0.25ml/min at 225 nm using a PDA detector. In UPLC, all of the analytes were resolved very well the resolution between Paracetamol and Ibuprofen was 5.4. The method was developed using different columns like UPLC @ BEH C8, C18; phenyl and HSS T3 with different length of the columns had studied under RP conditions. The final column chosen for the analysis was HSS T3 (100mm ×2.1, 1.8 µm) column which provided much stronger retention and resolution with good peak shape. The retention time of Paracetamol and Ibuprofen were 1.09 and 1.88 min, respectively. The linearity was obtained in the concentration range of 6.66-59.94 µg/ml and 8.0-72.0 µg/ml for Paracetamol and Ibuprofen with 0.9999 of correlation coefficients respectively. The specificity of the method was analyzed by the stress degradation study in acidic, alkaline, oxidative, thermal and photolytic conditions. The LOD for Paracetamol and Ibuprofen was found 0.84 and 0.52 µg/ml respectively. The LOQ was found 2.81 and 1.73 µg/ml for Paracetamol and Ibuprofen respectively. The validation follows the International Conference on Harmonization (ICH) guidelines.
Journal of Separation Science, 2018
Paracetamol is a widely used drug for fever and pain relief. Ibuprofen is a common nonsteroidal anti‐inflammatory drug. In this study, a sensitive and accurate reversed phase high performance liquid chromatography method was developed for the simultaneous determination of ibuprofen and paracetamol. The chromatographic separation was achieved on a Phenomenex C18 (250 mm, 4.6 mm, 5 μm) column. Fifty milli molar phosphate buffer (pH 7.5) and methanol were used as mobile phase in a gradient elution mode. The retention times of paracetamol and ibuprofen were 5.7 and 10.4 min, respectively. The linearity of the developed method was established in the range of 0.25 – 250 mg/L with a correlation coefficient of 0.9998 for both analytes. The limit of detection/quantification values were found to be 0.06/0.19 and 0.08/0.26 mg/L for ibuprofen and paracetamol, respectively. The method was successfully applied in drug samples in the form of tablets and suspensions. The calculated concentrations m...