International Journal of Advances in Pharmaceutical Analysis
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UV Spectrophotometric Method For The Estimation of Seratrodast in Bulk and Pharmaceutical Dosage Form
Get PDFA simple, specific, accurate and precise U.V Spectroscopy method was developed and validated for the estimation of Seratrodast in pharmaceutical dosage forms. The stock solution was prepared by weighing 100 mg of Standard Seratrodast in 100ml volumetric flask containing distilled water. The final stock solution was made to produce 100
A Validated RP-HPLC Method Development for Amoxicillin in Pharmaceutical Dosage Forms
Get PDFA rapid and simple Reverse Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for the quantification of Amoxicillin in tablet dosage form. Separation was achieved on Chromatopak-C18 (250mm×4.6×5micron) column in isocratic mode with mobile phase consisting of Acetonitrile: 0.2M Potassium dihydrogen phosphate buffer (pH 3) (22:78v/v) and conditions optimized with flow rate of 1 ml/minute and wavelength of detection at 283 nm. The retention time of Amoxicillin was found to be 6.4 min. Linearity was established for Amoxicillin in the range 10 100 μ g / ml with R2 value 0.999. This method was validated in accordance with ICH guidelines, the linearity, accuracy, precision, specificity, robustness, ruggedness, and system suitability results were within the acceptance criteria. Validation studies demonstrated that the proposed RP-HPLC method is simple, specific, rapid, reliable and reproducible for the determination of Amoxicillin for Quality Control level
Fluorescence spectroscopy and its applications: A Review
Get PDFFluorescence spectroscopy is a rapid, sensitive method for characterizing molecular environments and events samples. Fluorimetry is chosen for its extraordinary sensitivity, high specificity, simplicity and low cost as compared to other analytical techniques. It is widely accepted and powerful technique that is used for a variety of environmental, industrial, medical diagnostics, DNA sequencing, forensics, genetic analysis and biotechnology applications. It is a valuable analytical tool for both quantitative and qualitative analysis. This article presents a brief overview of the theory of fluorescence spectroscopy, together with examples of applications of this technique in organic and inorganic chemistry, medical diagnosis, medical science etc
Spectrophotometric Method for the Simultaneous Determination of Pseudoephedrine and Triprolidine in Bulk and Tablet Forms
Get PDFA spectrophotometric method was developed for the simultaneous determination of pseudoephedrine HCl (PSE) and triprolidine HCl (TRI) in bulk and dosage forms. The method involved the determination of pseudoephedrine in the presence of triprolidine using two wavelengths (257 nm and 290 nm). Beers law was obeyed in the concentration (152-760 ?g/ml) and (6.4-32 ?g/ml) with good linearity (0.9996 and 0.9996) for pseudoephedrine and triprolidine respectively. The accuracy and the precision of the developed method were very good (RSD ? 2%). The validity of the proposed method was confirmed through the statistical comparison of the obtained data with those of the official USP method
A novel validated RP-HPLC method for the estimation of canagliflozin in bulk and pharmaceutical dosage forms
Get PDFThe objective of the present study was to develop a simple, specific and accurate reverse phase high performance liquid chromatographic method for the determination of Canagliflozin in bulk and pharmaceutical dosage forms. The method is optimized on an inertsil ODS-3(250.6mm, 5) column with a mobile phase combination of 0.02% Formic acid: Acetonitrile (40:60) at a flow rate 1.2ml/min and the eluents were monitored at 230nm. Under these LC conditions Canagliflozin peak was eluted at 4.4 min. The developed method was validated as per ICH guidelines. The calibration curve was linear over a concentration range of 10-50g/ml (R 2 =0.999) and the mean percentage assay was found to be 98.2. The statistical data proved that proposed method is accurate, precise and reproducible. The method which is LC-MS compatible can be adopted in the routine analysis of Canagliflozin in bulk and pharmaceutical dosage forms
An analytical review on method development and validation of drugs used for alzheimers disease
Get PDFAlzheimers disease (AD) is a neurodegenerative disorder characterized by progressive memory defeat and impairment in behavior, language, and visuospatial skills. Current approved drugs for the treatment of Alzheimer disease (AD) include cholinesterase inhibitors (donepezil, galantamine and rivastigmine,) and the NMDA receptor antagonist memantine. These drugs can provide a symptomatic relief but they poorly affect the progression of the disease. There are several risk factors for the development of Alzheimers disease which include factors like age, genetic factor family history, Downs syndrome, head injury and cardiovascular diseases. Cardio vascular risk factors may include blood pressure, cholesterol, diabetes, obesity and smoking. People may experience cognitive mental illness, difficulty in understanding and thinking, forgetting things easily, making things complicated, mental confusion, difficulty in concentrating, inability to create old memories, inability to do simple things, or inability to recognize common things. The main objective of this review is discussion on various analytical methods used, different solvents used as mobile phase and their retention time. This review includes method development and validation of cholinesterase inhibitors like Donepezil, Galantamine, Rivastigmine and Tacrine combination of drugs which include cholinesterase inhibitors like Donepezil and NMDA receptor antagonist Memantine. The review is a collection of data including various analytical methods used, the different columns used, mobile phase used, flow rate, different detectors and detection wavelength and retention time. This review includes discussion on method development and validation of Alzheimers drugs and newly developed compounds which have lesser side effects and are proving more efficient for treatment of Alzheimers disease
H-Point Standard Additions method for the simultaneous determination of Paracetamol and Chlorzoxazone in Tablets using addition of both analytes and absorbance increment (?A)
Get PDFThe suitability of H-point standard additions method (HPSAM) to resolve of overlapping spectra corresponding to the paracetamol and chlorzoxazone was verified. The results showed that the H-point standard additions method with simultaneous addition of both analytes utilizing absorbance increment is suitable for the simultaneous determination of paracetamol and chlorzoxazone. The results of applying the H-point standard additions method showed that the two drugs could be determined simultaneously with the concentration ratios of paracetamol to chlorzoxazone varying from 1:2 to 2:1 in the mixed samples. In addition the means of the calculated RSD (%) were 1.40 and 1.92 in synthetic mixtures with 1.29 and 1.68 in dosage form for paracetamol and chlorzoxazone, respectively
Development and Validation of Computer Spreadsheet Used to Calculate Dissolution Profiles without Media Replacement
Get PDFCalculations carried out to generate dissolution profile data are complicated and subject to error to be performed manually, moreover and due to the repetitive nature of the dissolution testing experiments it is necessary to create a validated spreadsheet to replace and overcome the problems associated with manual calculations. A simple, user friendly spreadsheet was written to calculate dissolution profiles for a dissolution experiment where the volume of the dissolution medium for the vessel varies with time as the removed dissolution medium is not replaced with fresh one at each time point. The calculations of the spreadsheet were validated against manual calculations using a hand-held calculator; the results of the two methods were found to be comparable. The developed spreadsheet can be easily adapted for use in regulated environment after activating the security features embedded in Microsoft Excel software such as formula hiding, cell block and password protection
Bio-analytical method validation and its importance in pharma research - A review article
Get PDFBioanalytical method based on a variety of physico-chemical and biological techniques such as chromatography, immunoassay and mass spectrometry, must be validated prior to and during use to give confidence in the results generated. It is the process used to establish that a quantitative analytical method is suitable for biomedical applications. Bioanalytical method validation includes all of the procedures that demonstrate that a particular method used for quantitative measurement of analytes in a given biological matrix, such as blood, plasma, serum, or urine is reliable and reproducible for the intended use. The present manuscript focuses on the consistent evaluation of the key bioanalytical validation parameters is discussed: accuracy, precision, sensitivity, selectivity, standard curve, limits of quantification, range, recovery and stability. These validation parameters are described, together with an example of validation methodology applied in the case of chromatographic methods used in bioanalysis, taking in account to the recent Food and Drug Administration (FDA) guidelines and EMA guid
Application of Validated HPLC Method for Degradation Study of Sitagliptin and Metformin HCl
Get PDFA novel and simple reverse phase liquid chromatographic method has been established for the determination of Sitagliptin and Metformin HCl and studies its degradation pattern in pharmaceutical dosage forms. Sitagliptin and Metformin HCl is used to control Type 2 Diabetes. The proposed work was performed on Younglin( S.K) isocratic System UV DetectorC18 column (150 mm 4.6 mm). A mixture of Potassium Phosphate buffer pH-3.2 with orthophosphoric acid and acetonitrile was used as mobile phase in this method with flow rate 0.7 ml/min (UV detection at 203 nm) and the method was validated as per ICH guidelines. Forced degradation studies were performed by exposing the drug Sitagliptin and Metformin HCl to acidic, alkaline, oxidation and thermal stress degradations. The proposed RP-HPLC method was found to be robust and specific and this method is suitable for the assay of pharmaceutical dosage forms as well as kinetic studies