International Journal of Advances in Pharmaceutical Analysis
Not a member yet
100 research outputs found
Sort by
Bioanalytical method validation of fenofibrate by hplc using human plasma
Get PDFThe bioanalytical method validation of fenofibrate was performed with all the basic parameter by HPLC using human plasma. This research paper describes a specific procedure for validation of Fenofibrate in human plasma. The mobile phase used was simple and column friendly and was sufficiently sensitive to quantify Fenofibrate in amounts as low as 0.095g/ml. This limit of quantitation (LOQ) was determined as the lowest concentration with a coefficient of variation lower than 20% and the total accuracy of the method ranged from 101.99 to 107.41%. The LOQ of this method is better than those of other reported methods. The calibration curve plotted concentration versus area and was linear from 0.095 g/ml to 19.924 g/ml, having r 2 greater than 0.98 during the course of validation. The above method is valid for the analysis of drug in human plasma. The method with slight modification could be used for the drug analysis in various dosage forms
New validated rp-hplc method for simultaneous estimation of lamivudine and tenofovir disproxil fumarate in tablets
Get PDFA simple, specific and precise reverse phase high performance liquid chromatographic method was developed and validated for simultaneous estimation of Lamivudine and Tenofovir disproxil fumarate in tablets. Quantification was achieved by using a reverse-phase C18 column (Inertsil ODS 3V, 250 mm x 4.6 mm; 5) at 31 o C. The mobile phase consisted of a mixture of phosphate buffer and acetonitrile in the ratio of 55:45 v/v at a flow rate of 1.2 mL/min. The retention times of Lamivudine and Tenofovir disproxil fumarate were found to be 2.430 min and 4.550 min respectively. The developed method was validated as per ICH Guidelines for linearity, accuracy, precision, detection limit, quantification limit, ruggedness, robustness, specificity and system suitability. The percentage recoveries for both of the drugs from their tablets were found to be 98.48 % and 98.64 % respectively. The method may successfully be employed for the simultaneous determination of Lamivudine and Tenofovir disproxil fumarate in pharmaceutical tablet dosage forms
Stability indicating HPLC method development and validation for the simultaneous determination of Azithromycin & Ofloxacin in bulk and its dosage forms
Get PDFA simple, precise, sensitive and reproducible stability indicating Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method for determination of Azithromycin and Ofloxacin in tablet dosage form was developed. Chromatographic separation was achieved on Hypersil-Keystone RP C 18 (250 4.6 mm, 5m) column maintained at 30 C eluted with mobile phase at flow rate of 1.2 ml/min. The mobile phase consists of Buffer (0.02 M potassium dihydrogenphosphate): methanol: acetonitrile in the ratio 65:25:10 v/v at pH maintained at 3.2 with OPA was used and the determination was carried out at 285 nm. The retention time for Azithromycin and Ofloxacin were 9.7 min and 5.01 respectively. The linearity was found in the range of 5?50 ?g/ml for Azithromycin and 4?40 ?g/ml for Ofloxacin. In stability studies the drugs were well separated from degradation products. The degradation was studied in the individual standard drugs, their mixture and formulation which gave the idea about the orgin of the degradant products. The analytical method was validated as per ICH guideline for linearity, accuracy, precision, and specificity, limit of detection, limit of quantification, stability in analytical solution etc. and method can be extended to the analysis of Azithromycin and Ofloxacin in tablet formulations
Development and Validation of Glimepiride and Metformin in Human Plasma by HPLC: An application study
Get PDFA simple and cost effective RP-HPLC method is developed for simultaneous estimation of glimepiride (GLIM) and metformin (MET) at tablet dosage form using C-18 column (4.6 x 250mm, 5?, 100 A?) with a mobile phase composed ofmethanol: water (90:10% v/v) buffered with ortho phosphoric acid at a flow rate of1.0 mL/min (UV detection at 231 nm). The retention time of both drugs (GLIM and MET) are observed as 4.286 and 2.262 respectively. Human plasma spiking studies of both the API and the formulation at the concentration of (0.2g/mL - 1g/mL) for glimepiride and metformin (1g/mL - 5g/mL) expresses the standard correlation coefficients of 0.9998 and 0.9999 respectively for API and 0.9917 and 0.99 respectively for the tablet dosage form. The mean (%) recoveries of glimepiride and metformin are 99.98 and 99.9% respectively. The % RSD below 0.5 shows the high precision of the proposed method. Assay studies revealed that 98.05% of purity is observed for glimepiride and 99.69 for metformin in a tablet dosage form. Human plasma spiking studies revealed that a minimal quantum of glimepiride had been bound with the plasma proteins compare to metformin in the tablet dosage form. The method was validated as per the ICH guidelines
Development and validation of RP-HPLC method for loxapine in capsule dosage form
Get PDFA reversed phase-high performance liquid chromatography (RP-HPLC) method was developed for the determination of loxapine drug in tablet dosage form. The developed method was validated by measuring linearity, precision, limit of detection (LOD), robustness and ruggedness, drug recovery and for system suitability. Water and acetonitrile in the ratio 55:45 v/v was the mobile phase with C 18 column (250 mm x 4.5 mm x 5 m) as a stationary phase and 265 nm was the detection wavelength. The HPLC system was operated in isocratic mode. The measured retention time of loxapine drug was 6.88 minutes and the limit of detection was 0.035 g/ml, respectively. The linearity measured in the range 10-100 g/ml had a correlation coefficient of 0.999. The results of the parameters precision, robustness, recovery and formulation assay indicate that the developed method is a very good tool for the analysis of loxapine drug in tablet dosage form in bulk
Quantitative UV-spectrophotometry estimation of risperidone using hydrotropic solubilization phenomenon
Get PDFThe aim of present study was to develop simple and economical UV- pectrophotometric method for estimation of Risperidone using Area Under Curve (AUC) technique with the application of hydrotropic solubilisation phenomenon. Aqueous urea solution (30% v/v ) was used as hydrotropic agent for solubilising risperidone. The method is based upon integration of area under curve for analysis of risperidone in the wavelength range of 265.0 - 287.40 nm. The drug followed linearity in the concentration range of 4 - 24 g/mL with correlation coefficient value r 2 > 0.99. Proposed method was validated for accuracy, precision, repeatability and ruggedness as per ICH guidelines. The proposed method was applied for qualitative and quantitative estimation of risperidone in pharmaceutical formulation and results were found in good agreement with the label claimed. This developed method can be used for routine analysis of Risperidone in bulk and tablets
Analytical Techniques for Determination of Hydrochlorothiazide and its Combinations: A Review
Get PDFHydrochlorothiazide is chemically 6-chloro-1, 1-dioxo-3, 4-dihydro-2 H -1, 2, 4-benzothiadiazine-7-sulfonamide. Hydrochlorothiazide is a diuretic drug used for treatment of high blood pressure(hypertension) and accumulation of fluid (edema). It works by blocking salt and fluid reabsorption from the urine in the kidneys, causing increased urine output (dieresis). Hydrochlorothiazide is used to treat excessive fluid accumulation and swelling (edema) of the body caused byheart failure, cirrhosis, chronickidney failure, corticosteroid medications, and nephrotic syndrome. It can be used alone or in conjunction with otherblood pressure lowering medicationstotreat high blood pressure. This review focuses on the recent developments in analytical techniques for estimation of Hydrochlorothiazide alone or in combinations with other drugs in various biological media like human plasma and urine. This review will critically examine the (a) sample pretreatment method such as solid phase extraction (SPE), (b) separation methods such as thin layer chromatography (TLC), high performance liquid chromatography (HPLC), ultra performance liquid chromatography (UPLC), high performance thin layer chromatography (HPTLC), liquid chromatography coupled to tandem mass spectrometry (LC-MS) and capillary electrophoresis (CE), (c) other methods such as spectrophotometry, diffuse reflectance near infrared spectroscopy and electrochemical methods
IR quantification of fenofibric acid in bulk and oral dosage form
Get PDFSimple and sensitive infrared spectrophotometric method has been developed for the estimation of fenofibric acid in tablet dosage form.Beer?s concentration range was found to lie between 5 to 15 mg. The correlation coefficient for the method was found to be 0.9946 and the developed method was analyzed for specificity, linearity of response, precision and accuracy; thus the proposed method could be adopted for routine analysis of bulk drug and its formulation
Development and validation of a stability indicating RP-HPLC method for determination of flucytosine and its process related impurities in injectable pharmaceuticals
Get PDFA simple, sensitive reproducible and cost effective reversed-phase liquid chromatography (RPHPLC) method coupled with a photodiode array detector was developed and validated for determination of Flucytosine and its related substances in pharmaceutical dosage forms, especially for injectable solution. The separation was achieved from octadecylsilyl silica gel, C18 (4.6 mm x 250 mm, 5) column with a mobile phase consisting of HPLC grade Water and Methanol (95:5) at a flow rate of 1ml/min with UV detection at 260 nm at 30 C column temperature. Total run time was 10 min within which main compound and other known (Fluorouracil) and unknown impurities were separated. Stability indicating capability was established by force degradation experiments and separation of known degradation products. This chromatographic method was optimized using the samples generated from forced degradation studies and the impurity spiked solution. Good resolution between the peaks corresponds to process-related impurities and degradation products from the analyte were achieved. The method was validated for Accuracy, Repeatability, Reproducibility and Robustness, Linearity, LOQ and LOD were established for Flucytosine and its impurities in a single RPHPLC method. Therefore, this method can be used as a more convenient and efficient option for the analysis of Flucytosine assay and its related substances in injectable pharmaceutical dosage form to establish the quality of the drug product during routine analysis with consistent and reproducible results
Isolation and characterization of acid and base degradation products in Atenolol and Hydrochlorothiazide and a validated selective stability-indicating HPLCUV method for their quantification
Get PDFAtenolol (( RS )-2-{4-[2-Hydroxy-3-(propan-2-ylamino)propoxy]phenyl}acetamide) and Hydrochlorothiazide (6-chloro-1,1-dioxo-3,4-dihydro-2 H -1,2,4-benzothiadiazine-7-sulfonamide) are beta 1 (? 1 ) receptor blocker and diuretic drug respectively; however the combination dosage regime are used for cardiovascular therapy. Thus a forced degradation study was carried out upon this combination drug regime under acidic and basic environment in order to deconvolute the possible degradation product under specified stressed conditions. Under acidic conditions atenolol and hydrochlorothiazide were cleaved into 2-(4-(3-amino-2- oxopropoxy) phenyl) acetamide and 6-sulphamido benzothiazide. However, under basic conditions, the drugs were spliced into 2-(4-(2-hydroxypropoxy) phenyl) acetamide and 2-chloro 4-amino 1, 6-dihydro benzene sulphonamide respectively. The degradant peaks were elucidated by HPLC using C18 column with methanol: phosphate buffer (70:30 v/v) with a flow rate of 0.5ml/min (UV detection at 226nm). For quantitative method validation, linearity was observed over product concentration range 2g/ml - 100 g/ml (r 2 0.9992) with regression equation y=43432x. The products were first identified by LC-MS and further confirmed by FT-IR and 1 H 1 NMR. A specific and sensitive stability-indicating assay method for the simultaneous determination of the drugs, its process related impurities and degradation products was developed