Current Issue : January - March Volume : 2017 Issue Number : 1 Articles : 6 Articles
A simple, efficient, precise and accurate spectroscopic method has been developed and validated for quantitative estimation of diclofenac sodiumin bulk and pharmaceutical dosage form. Diclofenac standard solution was scanned in the UV rang (400-200 nm) in a 1 cm quartz cell in a double beam UV spectrophotometer. The absorption maxima of diclofenac were found to be 276.20 nm. The method obeys beers law in the concentration range from 10- 30 μg/ml. The correlation coefficient was found to be 0.9995 and regression of the curve was found y = 0.0324x + 0.0021 with excellent recovery 98.72-99.86%. Limit of detection and limit of quantitation were found to be 1.03 mg/ml and 3.12 mg/ml respectively. The method was validated for several parameters like accuracy, precision as per ICH guidelines. Value of % RSD and % recovery was found satisfactory, hence the proposed method is precise, accurate and economical hence can be used for routine analysis of diclofenac sodium....
For estimation of luliconazole in pharmaceutical dosage form, a simple, accurate and precise area under curve spectrophotometry method was developed. The area fewer than two points on the mixture spectra are directly proportional to the concentration of the component of interest is the AUC curve. The area selected for estimation of luliconazole was between 286 to 206 nm. The method represented regression coefficient (r2=0.999) at concentration range 5- 25 �µg/ml. Estimation of the drugs was found up to 100 % representing the accuracy of the method. The recovery of the luliconazole was found up to 100 %. Validation of the proposed method was carried out for its accuracy, precision and specificity according to ICH Q2 (R1) guidelines. The developed method can be successfully applied in routine work for the estimation of luliconazole in its pharmaceutical dosage form....
Lipophilicity (log P), is a physicochemical property of drugs having an application in new drug discovery and bioavailability studies. To reduce the time consumption and cost of log P determination by shake flask method, RP-HPLC method was presented for determination of lipophilicity of antiviral drugs (emtricitabine, nevirapine and zidovudine) using Agilent TC-C18 (4.5 x 250 mm, 5 μm particle size) column. The mobile phase consisted of a mixture of methanol and phosphate buffer (pH 7.4) saturated with octanol in isocratic elution mode. The capacity factor (k) for the drugs was determined by their retention time (Rt). The determined log P of the drugs emtricitabine, nevirapine and zidovudine was found to be -1.574, 1.457 and 0.417 respectively. The result by RP-HPLC method was nearly similar to the virtual log P calculated values. This method could be used for log P determination for neutral and basic antiviral drugs in regular analysis....
For various types of drug approval processes like INDs, NDAs ANDAs, veterinary drug approval process the data\nrelated to bioanalytical method development and validation is needed to sponsors. Various agencies namely US FDA, American\nAssociation of Pharmaceutical Scientists (AAPS), Health Protection Branch (HPB), Association of Analytical Chemists (AOAC),\nCenter for Veterinary Medicine (CVM), U.S. Department of Health and Human Services Food and Drug Administration, Center for\nDrug Evaluation and Research (CDER), European Medicine Agency (EMA), China Food and Drug administration (CFDA),\nEuropean Bioanalytical Forum (EBF), Global CRO council (GCC), ANVISA (Brazil), Japan Bioanalytical Forum (JBF) had done\ncollective affords at different timings to regulate and harmonize bioanalytical method development and validation. To\nharmonize bioanalytical method development and validation, the wide range of study and discussions were held during last\nthree decades including various workshop and conferences of official regulatory authorities. Regulatory guidance is available as\na result of the involvement of various official agencies. Bioanalytical method development and validation can be performed with\nvarious validation parameters by using LC-MS/MS and other analytical techniques. Also, there are various stability guidelines\nand procedures were set which are useful for bioanalysis. It is very advantageous for new researchers to have such collective\ninformation for development and validation of bioanalytical method which is presented in this review which may be upgraded\nin future. It can also be concluded that the process of formation of regulatory guidelines and up gradation of practical approach\nis constant during last three decades. The present review is having a special concern on regulatory and practical perspectives to\nresearchers for development and validation of the bioanalytical method. GLP is also one of the important factors for\nbioanalytical method development and validation....
A simple HPLC method was developed and validated for the simultaneous determination of Paracetamol, Cetirizine HCl and Ambroxol HCl in tablet dosage form by standard addition method. Chromatographic separation of the drugs, achieved on Lichrospher (Merck) C-18 (250 × 4.6 mm, 5 µ) column at 230 nm using mobile phase, comprising a mixture of Methanol:Acetonitrile:Buffer (0.5% w/v Di Potassium hydrogen orthophosphate, pH adjusted to 7 with 1N OPA) in the ratio of 75:3:22 v/v/v, at a flow rate of 1.2 ml/min. Paracetamol, Cetrizine HCl and Ambroxol HCl were eluted at the retention times of 2.5 min, 4.6 min and 7.8 min respectively. Calibration curves were linear over the range of 50-400 μg/ml for paracetamol and 10 µg – 650 μg/ml for both Cetrizine HCl and Ambroxol HCl, r2 values were 0.999, 0.998 and 0.998 respectively. The % assay of Paracetamol, Cetrizine HCl and Ambroxol HCl were found to be 99.8%, 101.6% and 100.1% respectively. The performance of the method was validated according to ICH guidelines. The proposed method was successfully applied for the determination of title drugs in tablet dosage form....
A simple method was developed for the simultaneous determination of acebrophylline {theophylline 7-acetic acid\n(THY), ambroxol (AMB)} and montelukast sodium (MNT) in tablet dosage form by RP-HPLC. Chromatographic separation of the\ndrugs, achieved on Syncronis C-18 (250Ã?â??4.6 mm, 5Ã?¼) column at 245 nm, mobile phase comprising a mixture of\nacetonitrile:buffer in the ratio of 70:30 v/v, at a flow rate of 1 ml/min. Theophylline-7-acetic acid, ambroxol and montelukast\nsodium were eluted at the retention times of 2.04 min, 4.65 min and 6.27 min respectively. Calibration curves were linear over\nthe range of 5-250 Ã?¼g/ml, 5 Ã?¼gââ?¬â??500 Ã?¼g/ml and 5-1000 Ã?¼g/ml for theophylline-7-acetic acid, ambroxol and montelukast sodium\nwith r2 values, 0.999 and 0.998 and 0.999 respectively. The % assay of theophylline 7-acetic acid, ambroxol and montelukast\nsodium were found to be 99.54%, 100.76% and 99.2% respectively. The performance of the method was validated according to\nICH guidelines. The proposed method was successfully applied for the determination of acebrophylline and montelukast sodium\nin tablet dosage form....
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