Current Issue : January-March Volume : 2018 Issue Number : 1 Articles : 11 Articles
The main goal of this review is to provide overview on the different method development techniques that are necessary to analyse the antiretroviral drugs. Different analytical techniques are to ensure the availability of safe and effective dosage forms of drugs to consumer’s quality assurance and quality control of pharmaceutical substances and formulations are essential. Anti-retroviral drug are used in the treatment of patients suffering from AIDS. The paper describes a selective, sensitive and robust method for determination of Nucleoside reverse transcriptase inhibitors (NRTIs), Non-nucleosid reverse transcriptase inhibitors (NNRTIs), Protease inhibitors (PIs), Integrase inhibitors (INSTIs), Chemokine receptor antagonists (CCR5 antagonists) by UV method, HPLC, UPLC, LC-MS/MS technique. The validated method can be useful in determining of antiretroviral drugs for therapeutic drug monitoring and in high throughput clinical studies....
There are only few published reports on determination of residual solvents in the analytical method development and there exists no detailed guidelines. Residual solvents from the process in the manufacturing of pharmaceuticals are hazardous and cause serious problems, so must be removed. This is much effort in this work is focused on the determination of analytical method for the determination of residual solvents. Bendamustine hydrochloride pure drug, various solvents, Shimadzu GC-2010 with head space auto injector and AOC ââ?¬â?? 5000 with head space auto injector were used. The method development based on residual solvent properties and many trails conducted on conditions like column selection, carrier gas flow, oven temperature and diluent. A simple HS-GC method for the determination of residual solvents in bendamustine hydrochloride using helium as the carrier gas at 3.0 ml/min with DB-624 (30.0 meters X 0.53 mm ID, 3.0 Ã?µm d.f. capillary) as column using FID as detector was developed. The developed method was validated and parameters were to be found within the limits of USP. The retention time for residual solvents individually and in spiked standard solution was determined. The %RSD for six injections should be NMT15%. The percentage recovery ranges from 84.57-118.86%. The correlation coefficient was R2 ââ?°Â¥ 0.999. The method was validated for repeatability, linearity, limit of detection, limit of quantification and recovery according to the International Conference on Harmonization guidelines. The method validation results indicate that the method was accurate, precise, linear and sensitive for solvents assessed. Excellent results were obtained, within the globally accepted validation reference values, particularly taking into account the low concentration levels investigated....
A simple, efficient and precise stability indicating RP-HPLC method has been developed and validated to measure zonisamide at wavelength (287 nm) in order to assay. Zonisamide is used to treat angina pectoris. Methanol was used as a solvent with λmax of drug was found to be 287 nm. The samples were eluted in an isocratic method using a water symmetry (C18, 5 µm, 4.6 mm × 250 mm) with a mobile phase consisting of pH 2.0 monobasic sodium phosphate: methanol: ACN (50:30:20) using as diluents through ambient temperature delivered at a flow rate 1 ml/min. This sample was used for degradation studies. Linearity was observed in the range of 5-35 μg/ml with a regression coefficient of 0.998. The stress degradation studies showed that zonisamide undergoes degradation in acidic, photo stability and alkaline conditions. Drug was found to be susceptible to acid and alkaline degradation than thermal and photo degradation conditions. The method was quantitatively evaluated in terms of accuracy (recovery), linearity, precision, selectivity and robustness in accordance with standard guidelines. The method is simple and suitable for analyzing zonisamide in bulk and in pharmaceutical formulations....
A simple, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed for the simultaneous estimation of valsartan and sacubitril in bulk. The method was developed using an Agilent C18 (4.6*250 mm, 5 μm) column, WATERS HPLC auto sampler, Separation module 2695, PDA detector 996 with a mobile phase containing pH 4.0 phosphate buffer: Acetonitrile (30:70% v/v ) in an isocratic technique with a flow rate of 1.0 ml/min at 254 nm. The retention times were found to be 3.233 min, 2.507 min for valsartan and sacubitril respectively. The proposed method was validated for precision, accuracy, range, linearity, ruggedness and robustness. The calibration curves of the drugs were linear with the correlation coefficient of 0.9996 and 0.9991 for valsartan and sacubitril respectively over the range of 20-100 μg/ml. The method was found to be sensitive and the validation parameters were within the approved limits....
In the present study, derivative spectrophotometric method in methanol has been developed for the determination of ambroxol in bulk and pharmaceutical dosage drug. The first, second and third order derivative spectroscopy was applied for the estimation of ambroxol using zero-crossing method. Ambroxol exhibits absorption maxima at 248 nm. In the first, second and third derivative spectra of ambroxol the amplitude of positive maxima were measured at 235 nm, 226 nm and 208 nm respectively. Linearity in the concentration range was found to be 10-30 μg/ml. The method were found to be simple economical accurate and reproducible and can be adopted in routine analysis of ambroxol in bulk and dosage form....
In the present study, derivative spectrophotometric method in methanol has been developed for the determination of nadolol in bulk and pharmaceutical dosage drug. The first, second and third order derivative spectroscopy was applied for the estimation of nadolol using zero-crossing method. Nadolol exhibits absorption maxima at 270 nm. In the first, second and third derivative spectra of nadolol the amplitude of positive maxima was measured at 266 nm, 271 nm and 236 nm respectively. Linearity in the concentration range was found to be 50-250 μg/ml. The method were found to be simple economical accurate and reproducible and can be adopted in routine analysis of nadolol in bulk and dosage form....
A RP-HPLC method is used for the quantitative estimation of the ondansetron in the injectable dosage form. Ondansetron hydrochloride is the racemic form of ondansetron and selective blocking agent of the serotonin 5-HT3 receptor type and used in the control of nausea and vomiting. The mobile phase used was a combination of sodium dehydrogenase orthophosphate monohydrate and 1-decanesulphonic acid sodium salt: Acetonitrile (75: 25). The detection was carried out at 216 nm and a flow rate of 1.5 ml/min. The retention time of ondansetron was found to be 22.90 min respectively. The assay of ondansetron was found to be 99.2%. The detector used was an UV detector; the reversed phase column used was ACE C8 (150 x 4.6 mm), 5 μ at ambient temperature. Thus the proposed method can be used for the routine analysis of the ondansetron in the pharmaceutical formulation....
A new, precise and economical spectrophotometric method has been developed and validated for the determination of lamivudine in bulk drugs. This method is based on the reaction of ninhydrin with primary amine present in the lamivudine in the presence of ammonium molybdate to form a Ruhemann’s purple product which was determined spectrophotometrically at 566.80 nm. The effects of variables such as temperature, heating time, concentration of colour producing reagent and stability of colour were investigated to optimize the procedure. This reaction proceeds quantitatively at 85±1°C in 15 min. Beer-Lambert’s law is obeyed in the concentration range of 6-20 μg/ml and is described by the regression equation Y = 0.0661x with a regression coefficient (r2) 0.9994. For lamivudine, the value of molar absorptivity and Sandell’s sensitivity are 15.486x103 L/mol/cm and 0.01486 μg/cm2 respectively. The LOD and LOQ are found to be 0.7635 and 2.313 μg/ml, respectively. The statistically validated results indicate that the proposed method has good sensitivity, accuracy, precision and stability. The method is green and economic as it does not involve any organic solvents....
High performance liquid chromatography is at present one of the classiest tool of the analysis. The estimation of raltegravir and lamivudine was done by RP-HPLC. The Phosphate buffer was pH 3.0 and the mobile phase was optimized with consists of acetonitrile: phosphate buffer mixed in the ratio of 45:55 % v/ v. Inertsil ODS 3V C18 column (4.6 x 150 mm, 5 m) or equivalent chemically bonded to porous silica particles was used as stationary phase. The detection was carried out by using PDA detector at 275 nm. The solutions were chromatographed at a constant flow rate of 1.0 ml/min. the linearity range of raltegravir and lamivudine were found to be from 150-450 g/ml of raltegravir and 50-150 g/ml of lamivudine. Linear regression coefficient was not more than 0.999. The values of % RSD are less than 2% indicating accuracy and precision of the method. The percentage recovery varies from 100.36 and 100.30% of raltegravir and lamivudine. LOD and LOQ were found to be within limit....
A novel UV-Spectroscopy and RP-HPLC method has been developed for the rosuvastatin calcium (ROSU) and clopidogrel bisulphate (CLOP) in tablet dosage form and validated according to ICH guidelines. The method is a simple, accurate, specific, precise, reproducible and sensitive. The Prontosil C18 column of dimension 250 x 4.6 mm i.d., particle size 10 m utilizing the system methanol: water (80:20 ratio) the mobile phase at the rate of 1 ml/min by employing 240 nm detector, where the drug retention time at 3.483 min of rosuvastatin calcium and 4.983 min of clopidogrel bisulphate. The method was observed to be linear (r2 = 0.999) over the range of 50-150 g/ml. The method was observed λmax at 240 nm. Employing the four different concentration of mobile phase and finally selected, since it gives sharp reproducible retention time. Employed the sample 20 µl, %RSD of ROSU 1.017 and CLOP 0.173, theoretical plates ROSU 7797.53 and CLOP 8257.53, tailing factor ROSU 1.1787 and CLOP 1.074, limits 2 NMT, accuracy ROSU 0.37 %RSD, recovery 99.59% and CLOP 0.18 %RSD, recovery of 100.41%. The method showed the good efficacy and results, no interference from the diluents or excipients was encountered. The method indicated the future scope in quality control, the estimation of rosuvastatin calcium and clopidogrel bisulphate for routine quality analysis investigation....
According to the Ayurvedic principles, a drug or therapy should not be only having pacifying effect on disease, but also it must not create any adverse effect or complication. A drug should not be only efficacious, but also easily available. Taking all these points into consideration, Dantashodhan churna (DC) was selected in the present study for the management of Danta Sharkara which has been mentioned by Sushruta. The present study was aimed at setting up a standard profile of Dantashodhan churna which was prepared using pharmacognostically authenticated raw drugs followed by subjecting it to detailed pharmacognostical and physicochemical analysis as per standard protocol. The observations were systematically recorded. Pharmacognostical findings of raw drugs (Parenchyma cells with starch grains, brown content, black debris, prismatic crystal, scleroids, perisperm cells, epidermal cells, aleurone grains, stone cells with stains, starch grain etc.) confirm the authentication of ingredients present in the finished product. Organoleptic features of DC made out of the crude drugs were within the standard range as mentioned in the classic. The pH value of DC was 7, loss on drying was 9.83% w/w, ash value was 5.6% w/w, water-soluble extract was 57% w/w, methanol soluble extraction was 12.9% w/w and high performance thin layer chromatography (HPTLC) at 254 nm and 366 nm resulted into 7 and 5 spots respectively....
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