Ibuprofen

The aim of present investigation was to develop a simple UV-visible spectrophotometric method for the determination of Ibuprofen (IBF) in its pure form and marketed formulations and to validate the developed method. Ibuprofen was estimated at UV maxima of 222.8 nm in pH 7.2 phosphate buffer using UV-Visible double beam spectrophotometer. Following the guidelines of International Conference on Harmonization (ICH), the analytical parameters like linearity, precision, and accuracy were studied. The obtained results of analysis were validated statistically and by performing recovery studies to confirm the accuracy of the proposed method. In the developed method, linearity over the concentration range of 2-20 µg/ml of IBF was observed and was found in agreement of Beer’s law. The linear regression was found to be 0.999. The precision (intra-day & inter-day) of method was found within limits (RSD < 2%). The sensitivity of the method was assessed by determining limit of detection and limit of quantification. It could be concluded from the results obtained that the method for estimation of IBF in pure form and in marketed tablets is simple, rapid, accurate, precise and economical and can be used, successfully, in the quality control of pharmaceutical formulations and routine laboratory analysis.

Purpose of this study was to develop a stability-indicating RP-HPLC method for routine analysis of Paracetamol (PARA), Caffeine (CAF) and Ibuprofen (IBU) in their combined solid dosage forms. The new RP-HPLC method was validated as per ICH, FDA and USP guidelines with respect to accuracy, precision, specificity, linearity, solution stability, robustness, sensitivity and system suitability. The method was developed by using a binary gradient mode of phosphate buffer (pH 7.2) and acetonitrile at a flow rate of 1.3mL/min for 15 minutes over C-18 (ODS, 150 x 4.6 mm, 5µm) column at ambient temperature. Injection volume was 20µL for both standard and sample solutions and the eluents were monitored with UV detection at 230nm.Accuracy was determined by the recovery tests of the drugs and found to be within a range of 99.89% to 100.33%. Intraday and inter-day precisions were demonstrated by a relative standard deviation being far less than maximum allowable limit (2.0%, according to FDA). The method showed linear response with a correlation coefficient (r2) value of 0.999 for all three drugs. Forced degradation studies in acidic, basic, oxidation and reduction media were carried out to establish the stability indicating tolerance of this method. Specificity was shown by the separation of drugs with high degree of resolution between them and absence of any interference from the excipients or degradation products. This method was successfully applied to assay the drugs in tablets and capsules. Hence this newly developed method can be considered suitable and reliable for the routine analysis of PARA, CAF and IBU in their solid dosage forms.

Garcinia pedunculata is a medicinal plant commonly known as Amlavetasa, belonging to the family Clusiaceae. The fruit of Garcinia pedunculata were used in the diet as a spice. It has been used as folk remedy in different ailments such as chronic catarrh, asthma, cough, bronchitis, cardiotonicand fever. The present study has been carried out to evaluate the anti inflammatory activity of aqueous extract of fruits of Garcinea pedunculata by carrageenan induced paw edema method. Eighteen healthy wistar albino rats were divided into three different groups of six rats each. Group I administered with normal tap water (5ml/kg) served as normal control. Group II administered with Ibuprofen 100mg/kg served as reference standard and group III administered with aqueous extract of fruits of Garcinea pedunculata(400mg/kg). In Acute oral toxicity study there was no mortality in any dose up to 2000mg/kg. The aqueous extract of fruits of Garcinea pedunculata has shown significant anti inflammatory activity by significantly decrease in the paw volume recorded at three different time interval compared with control group (**p< 0.01). It can be concluded that aqueous extract of fruits of Garcinea pedunculatahas potent anti inflammatory activity and there is a need for further scientific investigation to explore its anti inflammatory activity.

This  study was  focused over  the  designing  of sustained  release  HPMC  K100M  micropellet dosage form for  Ibuprofen which is an anti-inflammatory agent and broadly used for treating mild and severe pains. The approach of this study was to make a comparative evaluation among polymers  &  excipients  and  to  assess  the  effect  of  physicochemical  nature  of  the  active ingredients on the drug release profile. The prototype micropellets were obtained using drum pelletizer at 300 rpm. Percentage of water in binding liquid, i.e. IPA, is varied from 95 to 99% and  the effect  over  various parameters,  such as  particle size,  entrapment,  bulk  density and particle  shape,  were observed. Concerning the results of prototype preparation of Ibuprofen micropellets  were  prepared  using  HPMC  K100M,  as  release  retardant,  in  three  different concentrations i.e. 16.7%, 33.3% & 50%. Formulated micropellets showed particle size in the range of 275-284µm, bulk density (0.74-0.82 g/ml), % yield (25.9 -58.3%) & % entrapment (32.8-34.3%). Formulations showed the   maximum   desirability 0.996. Dry suspension formulation  parameters  such  as  pH  (5.15),  Viscosity  (450  cps),  Redispersibility  (5)  & Sedimentation volume (0.46 ml), was  found in  range. Formulation           PIH   were selected as the best   optimized  formulation  and  evaluated  for  In-vivo  parameters,  results  inferred  good sustainability with p>0.0001. Formulated micropellet showed sustained in-vitro dissolution rate, due to optimized polymer concentration. The micropellets were stable at 40°C±2°C/75%±5% RH as per ICH guidelines, after 3 months.

Ibuprofen self-emulsified drug delivery system (IBSEDDS) has been prepared, characterized and optimized to release 100% drug in one hour. The optimal formulation was subjected to stability and bioavailability studies in human volunteers. The stability was conducted under different storage temperature (4oC, room temperature and 37oC) for 8 months and evaluated for in-vitro drug release, particle size and turbidity. Bioavailability was evaluated after administration of a single oral dose of two formulations, test (HPMC capsule containing IBSEDD) and reference (HPMC capsule containing 50 mg drug in soybean oil), by 6 health human volunteers. The results showed that IBSEDDS was stable under different storage temperatures and the drug was more stable at 4oC. The changes in particle size and turbidity were lesser at room temperature.  The pharmacokinetic parameters for test/reference were: the Cmax , 0.892/0.468 ug/ml,  the Tmax, 1/1.5hr and the AUC0-∞, 3.956/1.986 mg.hr/ml. The % RBof IBSEDDS was 199.114. In a conclusion, the IBSEDD formulation stored at 4oC were more stable regarding drug content but samples stored at room temperature were more stable regarding particle size and turbidity. The IBSEDD formulation showed higher rate and extent of drug absorption and higher bioavailability compared to the oily drug solution.

The present manuscript describes simple, sensitive, rapid, accurate, precise and economical Q-absorbance ratio method for the simultaneous determination of ibuprofen and chlorzoxazone in bulk and synthetic mixture. Absorbance ratio method uses the ratio of absorbances at two selected wavelengths, one which is an isoabsorptive point and other being the λ-max of one of the two components. Ibuprofen and Chlorzoxazone show an isoabsorptive point at 227 nm in methanol. The second wavelength used is 221 nm, which is the λ-max of Ibuprofen in methanol. The linearity was obtained in the concentration range of 2-20 μg/ml for both Ibuprofen and Chlorzoxazone. The concentrations of the drugs were determined by using ratio of absorbances at isoabsorptive point and at the λ-max of Ibuprofen. The method was successfully applied for the determination of these two drugs in synthetic mixture. No interference was observed from excipients present in the synthetic mixture. The suitability of this method for the quantitative determination of Ibuprofen and Chlorzoxazone was proved by validation. The proposed method was found to be simple and sensitive for the routine analysis of these two drugs in synthetic mixture. The results of analysis have been validated statistically and by recovery studies. 

A simple, sensitive, accurate and precise simultaneous UV spectrophotometric method has been developed for the estimation of Ibuprofen, Paracetamol and Caffeine in tablet dosage form. The absorption maxima of the drugs were found to be 223, 248 and 272 nm for Ibuprofen, Paracetamol and Caffeine respectively, in methanol, using a Shimadzu UV–Visible spectrophotometer (model UV-1800). Ibuprofen, Paracetamol and Caffeine obeyed Beer’s law in the concentration range of 10-70 µg ml-1, 10-60 µg ml-1 and 10-70 µg ml-1 respectively. The correlation coefficient was found to be 0.999, 0.999, and 0.999 for Ibuprofen, Paracetamol and Caffeine respectively. The method was validated for various parameters according to ICH guidelines. The low relative standard deviation values indicate good precision and high recovery values indicate accuracy of the proposed method. Assay results were in good agreement with label claim.

An accurate, simple, precise and sensitive HPLC method with UV detection was developed and validated to separate and detect ibuprofen in human plasma using Nimesulide as an internal standard. Ibuprofen and Nimesulide were extracted from human plasma using acetonitrile protein precipitation and HPLC analysis was performed using Waters 515 Series pumps combined with a Waters PDA 2998 series photo diode array detector (DAD). The column used was Agilent C18 column (150mm×4.6mm, particle size 5-micron Agilent, USA). Analysis was isocratic at 1.5 ml/min flow rate with ACN: Buffer (0.025M Potassium dihydrogen ortho phosphate) pH 4.5 (55:45, v/v) as mobile phase. The mobile phase was premixed, filtered through a 0.2 µm nylon membrane filter to remove any particulate matter and degassed by sonication before use. The elution was detected at 230 nm. Each solution was injected in triplicate, and the relative standard deviation (R.S.D.) was measured. The retention times of Ibuprofen 2.24 min and for I.S. 1.72 min respectively. The method was validated over the range of 0.5-8.0 μ/ml. The limit of detection was 0.06μg/ml and the limit of quantification was 0.193μg/ml for ibuprofen. Inter-day as well intra-day replicates of Ibuprofen, gave % R.S.D. below 2.07 and 2.001 respectively  The absolute recovery of ibuprofen was greater than 90% were achieved. This method of analysis for Ibuprofen determination using RP-HPLC was applied for determination of Ibuprofen in plasma.

Two simple, rapid, precise and accurate spectrophotometric methods have been developed for simultaneous analysis of Ibuprofen (IBU) and Famotidine (FAMO) in their combined dosage form. Method A, absorbance correction method involves measurement of amplitudes at 220 nm (for IBU) and 288 nm (for FAMO) in zero derivative spectra. Method B, ratio derivative spectrophotometry, involves division of spectra of IBU by one selected standard spectrum of FAMO and then measuring amplitudes at 234.2 nm in ratio derivative spectra for estimation of IBU. Similarly, spectra of FAMO are divided by one selected standard spectrum of IBU and then amplitudes at 277.8 nm in ratio derivative spectra are measured for estimation of FAMO. Developed methods were validated according to ICH guidelines. The calibration graph follows Beer’s law in the range of 2 to 60 µg/ml for IBU and 3.8 to 4.6 µg/ml for FAMO with R2 value greater than 0.999. Accuracy of all methods was determined by recovery studies and showed % recovery between 98 to 102%. Intraday and Interday precision was checked for both the methods and mean %RSD was found to be less than 2 for these methods. The methods were successfully applied for estimation of IBU and FAMO in marketed formulation.