Method For Determination Of Ibuprofen Research Articles

Stability-Indicating HPLC Method for Determination of Ibuprofen and Famotidine Degradation Products.

A new stability-indicating high-performance liquid chromatographic method for the quantitative determination of ibuprofen and famotidine degradation products in combined pharmaceutical products was developed and validated. The current aim of this study is to develop a rapid, accurate and robust analytical stability indicating impurity method that can separate ibuprofen, famotidine and their related impurities by using a reversed-phase high-performance liquid chromatography. A Zorbax SB-Phenyl column (4.6 × 150mm2, 5-μm particle size) with mobile phase containing phosphate buffer solution with a pH value of 3.0 and acetonitrile was used. The flow rate was 0.8mL/min and the analytes were detected by UV detector at 265nm. The retention times of ibuprofen and famotidine were 18.43 and 5.14min, respectively. This method was validated to confirm specificity, linearity, sensitivity (limit of detection and limit of quantitation), precision, accuracy, robustness and sample stability according to the International Conference on Harmonization guidelines. Studies have been completed and reported with two active substances in the combined dosage form and seven impurities in total. There is no method in the literature that simultaneously distinguishes and quantitatively analyzes both active substances and degradation products.

Development and validation of a liquid chromatography-tandem mass spectrometry method for determination of ibuprofen in human plasma

Ibuprofen is widely used to reduce fever, pain, and inflammation and in the treatment of patent ductus arteriosus (PDA) in preterm infants. However, to study the impact of pharmacokinetics of ibuprofen on the rate of ductus arteriosus closure in humans, a quantitative method is required. Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is a highly sensitive, accurate, reliable, fast, and simple bioanalytical method. In this study, we developed and utilized an LC-MS/MS method to determine ibuprofen bioavailability. One of the novel aspects of this work is the small specimen volume required for the analysis (i.e., 50 µL). The calibration curve was linear across a concentration range of 0.15–50 μg/mL. The coefficient of variation for intra-day and inter-day precision was within 0.78%–7.21% and accuracy was within 97.52%–107.21% of the nominal values for low, medium, and high quality control (QC) concentration levels—QCL, QCM, and QCH (0.45, 9.0, and 40.0 μg/mL, respectively). For ibuprofen concentrations at the lower limit of quantitation (LLOQ), intra-day and inter-day accuracy were 98.11% and 99.81%, respectively; however, the intra-day and inter-day precision were 1.89% and 5.37%, respectively. The pharmacokinetic study involved 18 neonatal subjects who were grouped into low- or high-dose ibuprofen groups. The median maximum concentration for low- and high-dose regimens were 16.05 (14.21–19.32) and 24.10 (20.63–32.03) µg/mL, respectively, and the median elimination rate constant was 0.041 (0.026–0.047) and 0.071 (0.050–0.073) h−1, respectively. Thus, the fully validated LC-MS/MS method was determined to be suitable for analyzing unknown plasma samples for ibuprofen pharmacokinetic, bioavailability, and bioequivalence studies.

Development and validation of LC-MS-MS method for determination of ibuprofen in human plasma

Development and validation of LC-MS-MS method for determination of ibuprofen in human plasma

Enantiomeric separation of 2-arylpropionic acid nonsteroidal anti-inflammatory drugs and β-blockers by RP-HPLC using an amylose chiral stationary phase for the enantioselective skin permeation study

The enantioselectivities of eight 2-arylpropionic acid nonsteroidal anti-inflammatory drugs (2-APA NSAIDs) and two β-blockers on an amylose-tris(3,5-dimethylphenylcarbamate)-based Chiralpak AD-RH (150 × 4.6 mm, 5 μm) column were studied in reverse phase (RP) elution mode. The influencing factors such as mobile phase composition, organic modifiers, and column temperature were investigated. For most of the selected NSAIDs, baseline enantioseparation was achieved using a mobile phase composition of acetonitrile–0.05% trifluoroacetic acid aqueous solution. For the β-blockers, baseline enantioseparation was achieved using a mobile phase composition of acetonitrile–borate buffer solution with 0.1% triethylamine (pH 9.0; 10 mM). Our study has demonstrated for the first time that the addition of an organic modifier, ethanol, in the mobile phase dramatically improves the resolution of the analytes such as flurbiprofen, suprofen, propranolol and metoprolol under reverse phase chromatographic conditions. The methods for the enantioselective determination of ibuprofen, flurbiprofen and propranolol were validated. The enantioselective skin permeation studies of propranolol hydrochloride presented here showed that there was no observable enantioselective permeation of propranolol across the excised rat skin, but L-linalool, a chiral enhancer, resulted in enhanced enantioselectivity, with a better permeation enhancing effect on R-propranolol than on S-propranolol and RS-propranolol across the excised rat skin.

Development and Validation of an UPLC Method for Rapid Determination of Ibuprofen and Diphenhydramine Citrate in the Presence of Impurities in Combined Dosage Form

A novel, stability-indicating gradient reverse-phase ultra-performance liquid chromatographic method was developed for the simultaneous determination of ibuprofen and diphenhydramine citrate in the presence of degradation products and process related impurities in combined dosage form. The method was developed using C18 column with mobile phase containing a gradient mixture of solvent A and B. The eluted compounds were monitored at 220 nm. Ibuprofen and diphenhydramine citrate were subjected to the stress conditions of oxidative, acid, base, hydrolytic, thermal, and photolytic degradation. Major unknown impurity formed under oxidative degradation was identified using LC-MS-MS study. The developed method was validated as per ICH guidelines with respect to specificity, linearity, limit of detection, limit of quantitation, accuracy, precision and robustness. The described method was linear over the range of 0.20-6.00 μg/mL (r>0.998) for Ibuprofen and 0.084-1.14 μg/mL for diphenhydramine citrate (r>0.998). The limit of detection results were ranged from 0.200-0.320 μg/mL for ibuprofen impurities and 0.084-0.099 μg/mL for diphenhydramine citrate impurities. The limit of quantitation results were ranged from 0.440 to 0.880 μg/mL for ibuprofen impurities and 0.258 to 0.372 μg/mL for diphenhydramine citrate impurities. The recovery of ibuprofen impurities were ranged from 98.1% to 100.5% and the recovery of diphenhydramine citrate impurities were ranged from 97.5% to 102.1%. This method is also suitable for the simultaneous assay determination of ibuprofen and diphenhydramine citrate in pharmaceutical dosage forms.