Current Issue : July - September Volume : 2013 Issue Number : 3 Articles : 10 Articles
The aim of present work was focused on development of an analytical method for estimation of drug in tablet dosage form by using RP-HPLC method. Chromatographic technique is most widely used technique for analysis of single component or multi-component formulations. The proposed methods were applied for the determination of drugs in bulk and tablet dosage form. The technique also allow for the separation as well as analysis of different drug that are present in different formulations. The technique is allowed for separation of respective drugs from the excipients contained in the formulations and thus each drug in the multi-component can be easily separated. An analytical method was developed in order to carry out the assay of drugs present in tablet formulations. Validation studies were performing in order to access the validation parameters for the analytical method developed in accordance to ICH guidelines....
A simple and specific HPTLC method has been developed for simultaneous estimation of Montelukast Sodium and Olopatadine Hydrochloride in bulk and simulated dosage form. The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. Methanol: Toluene: Ethyl acetate: Ammonia in ratio of 4.6: 4: 1: 0.4 v/v/v/v is used as a mobile phase. The Rf value of Montelukast Sodium and Olopatadine Hydrochloride were found 0.81±0.0081 and 0.20±0.0080 respectively. The linearity for Montelukast Sodium and Olopatadine Hydrochloride were found to be in range of 400-2400 ng/band and 200-1200 ng/band respectively. The % recoveries of Montelukast Sodium and Olopatadine Hydrochloride were found to be in the range of 98.12-99.78% and 98.96-101.76% respectively. The proposed method was validated and successfully applied for the estimation of Montelukast Sodium and Olopatadine Hydrochloride in simulated dosage form....
Swine flu (swine influenza) is a respiratory disease caused by viruses (influenza viruses). Neuraminidase inhibitors class of antiviral drug used for treating and preventing flu. Mainly oseltamivir (Tamiflu) and zanamivir (Relenza), Laninamivir (Inavir), and Peramivir belong to neuraminidase inhibitors act against both influenza A and influenza B. Swine flu is resistant to M2 ion channel protein ligand drugs amantadine (Symmetrel) and rimantadine (Flumadine). The clinical and pharmaceutical analysis of these drugs requires effective analytical procedures for quality control and pharmacodynamics and pharmacokinetic studies. An extensive survey of the literature published in various analytical and pharmaceutical chemistry related journals has been conducted and the instrumental analytical methods which were developed and used for determination of swine flu drugs in bulk drugs, formulations and biological samples have been reviewed. This review covers the time period till 2012 during which many methods including spectroscopic, chromatographic titrimetric methods were reported. The application of these methods for the determination of swine flu drugs in pharmaceutical formulations has also been discussed....
A simple, sensitive, rapid, accurate, precise and economical first order derivative spectrophotometric method has been developed for the simultaneous determination of Fluticasone Propionate (FLP), Azelastine Hydrochloride (AZH) in combined nasal spray preparations. The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The first order derivative spectra were obtained in acetonitrile and the determinations were made at 253 nm (ZCP of Azelastine Hydrochloride) for Fluticasone Propionate and 236 nm (ZCP of Fluticasone Propionate) for Azelastine Hydrochloride. The linearity was obtained in the concentration range of 10-30 μg/ml for Fluticasone Propionate and 28-84 μg/ml for Azelastine Hydrochloride. The mean % recovery was 99.96±0.39% and 100.29±0.37% for Fluticasone Propionate and Azelastine Hydrochloride, respectively. The recovery studies confirmed accuracy of proposed method and low values of standard deviation confirmed precision of method....
A rapid ultra-performance liquid chromatography (UPLC) method was developed for feasible separation and quantification of 5%w/v solution of multiple amino acids for intravenous infusion. The analysis was performed on Accquity UPLC system with Accquity UPLC AccQ. Tag Ultra Column within 8 min. The correlation coefficient values (r2 > 0.9978) indicated good correlations between the compounds’ concentrations and their peak areas within the test ranges. The limits of quantitation and detection of 18 amino acids were 30–198 ng/mL and 10–70 ng/mL, respectively. The recoveries ranged from 99.84% to 103.89% and the overall relative standard deviations for intra and inter day were lower than 1.4%. The results showed that UPLC was a powerful tool for the analysis of amino acids....
The quality of the herbals depends on the type of extraction procedures used. In the present study targeted analytical plant marker Embelin which has Proven therapeutic effect was extracted using soxhlet apparatus and percolation method from Embelia ribes plant seeds commonly called as vidang. The isolated compound has similar identical characteristics when compared with standard. The % purity and Quantitative analysis of Embelin in raw material and marketed churna was done by developed validated chromatographic methods. The purity of the compound extracted by soxhlet and percolation procedures was found to be 98.02% and 100.47%, respectively. The linearity range for HPLC and HPTLC was found to be 50-100 µg/mL and 200-1200 ng/spot, respectively. HPLC analyses were carried out at using Kromasil C18 column (5 μm, 4.6 × 150 mm). The mobile phases consisted of acetonitrile (A) and phosphate buffer, pH 3.0 (B) in proportion of 95:5 v/v carried out at 280 nm and for HPTLC the mobile phase consisted of n-hexane: ethyl acetate: formic acid in the proportion of 5: 4: 1% v/v/v. scanned at 292 nm .Satisfactory validation parameters results for HPLC were obtained with respect to repeatability %RSD is 1.37, and recovery (98.93-100.36% recovery). In case of HPTLC; repeatability % RSD is 1.89 and % recovery is 98.97-101.77, respectively. Hence the developed validated method can be used for the routine quality control of raw material variability and inconsistency of its content in finished products and these methods can also be useful to determine the %purity for in house isolated Embelin standard....
A simple and sensitive HPTLC method has been developed for determination of Fosinopril Sodium in its pharmaceutical dosage forms. Stationary phase was Silica gel G60 F254 pre-coated on aluminum sheet and mobile phase consisting of Tetra hydro furan: Hexane: NH3 (5:5:0.5 v/v) was used. The detection of spot was carried out at 215 nm. The Rf value was found to be 0.37±0.02. The methods were validated in terms of linearity, accuracy and precision. The linearity curve was found to be linear over 1000-6000 ng/spot. The method was found to be accurate over 100.29% –100.50%. The LOD and LOQ were found to be 210 and 636 ng/spot respectively. The proposed method was validated by determining its sensitivity, accuracy and precision which proves suitability of the developed method for the routine estimation of Fosinopril Sodium in solid dosage form and applied successfully for the analysis of the drug in its tablets dosage forms....
The purpose of present research work was to study process validation for Nifedipine Sustained Release 20mg Coated Tablet dosage formulation. In pharmaceutical organizations, validation is a fundamental segment that supports company commitment to quality assurance. Quality cannot be adequately assured by in-process and finished inspections and testing but it should be built in to the manufacturing process. These processes should be controlled in order that the finished product meets all quality specifications.The critical process parameters were identified with the help of process capability and evaluated by challenging its lower & upper release specification. Three initial process validation batches (I, II & III) of same size, method, equipment & validation criteria was taken. The critical parameters involved in sifting,milling, dry mixing, preparation of granulating agent, wet mixing, wet milling, drying, sizing, lubrication, compression stages & coating were identified and evaluated as per validation master plan. The outcome indicated that this process validation data provides high degree of assurance that manufacturing process produces product meeting its predetermined specifications and quality attributes....
The present manuscript describes simple, sensitive, rapid, accurate, precise and economical spectrophotometric method for the simultaneous determination of Mefenamic acid and Tizanidine in their combined dosage form. The method was based on and solving simultaneous equations for analysis of two the drugs using methanol as solvent. In this method, the absorbance was measured at 289 nm for Mefenamic acid and 318 nm for Tizanidine. The linearity was found to be in the concentration range of 8-28 μg/ml and 2-22 μg/ml for Mefenamic acid and Tizanidine respectively. Recovery studies confirmed the accuracy of proposed method and results were validated as per ICH guidelines. The method can be used for routine quality control of pharmaceutical formulation containing Mefenamic acid and Tizanidine....
A simple and accurate HPTLC method has been developed for determination of Glucosamine and Boswellia serrata extract in their tablet dosage form. The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. Toluene: Ethylacetate (2.5:1.5 v/v) as a mobile phase-A and N-Butanol: Water: Glacial acetic acid (3:1:1 v/v/v) as a mobile phase-B. After that saturation time is optimized for the better separation. The Rf value of Glucosamine, 11-Keto-β-Boswellic acid and Acetyl-11-Keto-β-Boswellic acid are 0.33±0.02, 0.43±0.02 and 0.51±0.02 respectively were found. The linearity for GLU, 11-KBA and A-11-KBA were in the range of 6250-31250, 300-1500 and 150-750 ng/band respectively. The % recoveries of GLU, 11-KBA and A-11-KBA were found to be in the range of 99.93-99.96, 99.06-99.40 and 98.22-99.36% respectively. The proposed method was validated and successfully applied for the estimation of GLU, 11-KBA and A-11-KBA in combined tablet dosage form....
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