Current Issue : January - March Volume : 2019 Issue Number : 1 Articles : 9 Articles
The use of electronic cigarettes (e-cigarettes) is a growing trend in population. E-cigarettes are evolving at a rapid rate with variety\nof battery powered devices and combustible nicotine refills such as e-liquids. In contrast to conventional cigarettes which are\nstudied well for their toxicity and health effects, long-term clinical data on e-cigarettes are not available yet. Therefore, safety of\ne-cigarettes is still a major concern. Although the Food and Drug Administration (FDA) has recently started regulating e-cigarette\nproducts, no limits on nicotine and other ingredients in such products have been proposed. Considering the regulatory requirements,\nit is critical that reliable and standardized analytical methods for analyzing nicotine and other ingredients in\ne-cigarette products such as e-liquids are available. Here, we are reporting a fully validated high-performance liquid chromatography\n(HPLC) method based on nicotine peak purity for accurately quantifying nicotine in various e-liquids. The method\nhas been validated as per ICH Q2(R1) and USP <1225> guidelines. The method is specific, precise, accurate, and linear to analyze\nnicotine in e-liquids with 1 to >50 mg/mL of nicotine. Additionally, the method has been proven robust and flexible for parameters\nsuch as change in flow rate, column oven temperature, and organic phase composition, which proves applicability of the\nmethod over wide variety of e-liquids in market....
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Eudragit® L100 is a commonly used polymer in a coating layer of modified-release drug\nformulation to prevent drug release in the stomach. The amount of Eudragit® L100 in the formula\ndetermines the dissolution profile of drug at its release medium. Hence, its quantification in reference\nproduct will facilitate the formulation of a bioequivalent drug product. Some analytical methods\nincluding size-exclusion chromatography (SEC) have been reported for characterization of Eudragit®\nL100 either as single component or its conjugate with the enzyme, but none for its quantification\nin drug formulation. In this work, an SEC method with charged-aerosol detection (CAD) was\ndeveloped for determination of Eudragit® L100 in an enteric-coated tablet formulation using Waters\nUltrahydrogel 1000 andWaters Ultrahydrogel 120 columns in series. The mobile phase was a mixture\nof 90:10 (v/v) 44.75 mM aqueous ammonium acetate buffer, pH 6.6 and acetonitrile pumped at\na constant flow rate of 0.8 mL/min in isocratic mode. The method was validated for specificity,\nworking range, limit of detection (LOD), limit of quantification (LOQ), accuracy and precision.\nThe method was shown to be specific for Eudragit® L100 against the diluent (mobile phase) and\nplacebo of a coating layer for the tablet. A good correlation coefficient (r = 0.9997) of CAD response\nagainst Eudragit® L100 concentration from 0.1â??1.0 mg/mL was obtained using polynomial regression.\nLOD and LOQ concentrations were 0.0015 and 0.0040 mg/mL, respectively. The mean recovery of\nEudragit® L100 was in the range of 88.0â??91.1% at three levels of working concentration: 50%, 100%\nand 150%. Six replicated preparations of samples showed good precision of the peak area with %\nrelative standard deviation (RSD) 2.7. In conclusion, the method was suitable for quantification of\nEudragit® L100 in an enteric-coated tablet formulation....
Alogliptin benzoate, a member of dipeptidyl peptidase-4 inhibitors, is a recent drug developed by Takeda Pharmaceutical\nCompany for the treatment of Type 2 diabetes; it potentiates the effect of incretin hormones through the inhibition of their\ndegradation. Alogliptin can be used alone or in combination therapy. A new sensitive and rapid HPLC method was developed for\nthe determination of alogliptin benzoate in bulk and pharmaceutical dosage forms; it was validated according to ICH and FDA\nguidelines. The HPLC analysis was performed on the Agilent 1200 system equipped with a Hypersil Gold Thermo Scientific C18\n(250 cm Ã? 4.6mm) 5 .. column, with a mixture of acetonitrile and ammonium carbonate buffer in the ratio of 55 : 45 v/v as the\nmobile phase, at the flow rate of 1.0 mL/min. The detection was performed at the wavelength .. of 277, and the retention time of\nalogliptin benzoate was around 4 min. The total run time was 6.0 min. The calibration plot gave linear relationship over the\nconcentration range of 85â??306 ..ml. The LOD and LOQ were 0.03 and 0.09 .., respectively. The accuracy of the proposed\nmethod was determined by recovery studies and was found to be 100.3%. The repeatability testing for both standard and sample\nsolutions showed that the method is precise within the acceptable limits. RSD% of the determination of precision was <2%. The\nresults of robustness and solutions stability studies were within the acceptable limits as well. The proposed method showed\nexcellent linearity, accuracy, precision, specificity, robustness, LOD, LOQ, and system suitability results within the acceptance\ncriteria. In addition, the main features of the developed method are low run time and retention time around 4 min....
The aim of the study was to develop and validate a visible spectrophotometric method for the quantitative estimation of mesalamine in pure form and in formulations i.e. in tablets and suppositories. 0.1N HCl selected as solvent, 0.5 ml of 0.5% MBTH used as chromogenic reagent and 2 ml of 1% cerric ammonium sulphate solution was added as oxidizing agent to develop the color. The intensity of the developed brown colored complex measured at an absorption maximum of 476 nm. Beer-Lambert’s law was obeyed within the concentration range of 0.5 - 6.0 μg/ml and the correlation coefficient was found to be 0.999. LOD and LOQ were 0.05 and 0.17 μg/ml respectively. The developed method validated for accuracy and precision as per ICH Q2R1 guidelines. The method successfully applied for the quantitative estimation of the drug in tablets and suppositories and the percentage recoveries were found to be 99.0% and 98.4% respectively. This method can be used for routine analysis of mesalamine pure drug and its formulations....
A stability indicating RP-HPLC chromatography method was developed for the estimation of metformin, pioglitazone and glimepiridein tablet dosage form. The separation was achieved on column (4.6 × 250 mm, 5 μm) using acetonitrile and 0.01 % OPA in the ratio of (60:40, v/v) as mobile phase and flow rate 1.0 ml/min. Detection was carried out in U.V detector at 254.0 nm. The retention time 2.300 min for MET, 5.6833 min for PIO and 9.0500 min for GLP respectively. The linearity of the MET, PIO and GLP was found over the range of 100 μg/ml-500 μg/ml, 3 μg/ml-15 μg/ml and 0.2 μg/ml-1.0 μg/ml for MET, PIO and GLP respectively. The method was found to be precise, accurate, robust and rugged as indicated % RSD values less than 2. For developing the force degradation profile the drug product is exposed to degradation medium like acidic, basic, oxidative, neutral, thermal and photolytic. The parent drugs and degradation products formed were well resolved under optimized chromatographic conditions. The % of degradation for metformin was 2.41% (acid), 8.08 % (base), 10.85 % (oxide), 7.67 % (water), 0.42 % (thermal) and 0.21 % (photo) pioglitazone 6.58 % (base), 2.85% (oxide), 4.89 % (water), 2.92% (thermal), 2.01% (photo) while for glimepiride 2.41 % (acid), 3.01 % (oxide), 2.11% (water), 1.91% (thermal) and 0.19% (photo) which is in agreement with ICH limit....
The present research work focused on development and validation of first order derivative and area under curve (AUC) UV spectroscopic method for the estimation of cyamemazine tartrate in bulk and its pharmaceutical dosage form. The solutions of standard and sample solutions were prepared by ethanol. The calibration curve was observed in the concentration range of 2-12 μg/ml for both methods. In first order derivative spectroscopic method absorbance was measured at 259 nm, 289 nm and zero cross-270 nm. In area under curve UV spectroscopic method two wavelengths were selected in the range of 264 nm-276 nm. Other studies of assay, accuracy and precision was carried and statically validated. The described methods suggest utilizing for the routine quality control analysis of analytical laboratories. So, the developed methods were found to be linear, precise and accurate....
Good quality drugs fulfilling the regulatory parameters and produced per the current good manufacturing (CGMP) standards\nare very critical for best therapeutic outcome in patient therapy. Hence, this study assesses quality as well as physicochemical\nbioequivalence of five brands of glibenclamide tablets marketed in Addis Ababa using in vitro and in vivo methods. Friability,\ndisintegration, dissolution, and assay for the content of active ingredients were evaluated using the methods described in theBritish\nPharmacopeia (2009) and United States Pharmacopeia (2007). All the brands of glibenclamide tablets complied with the official\nspecification for hardness, friability, disintegration, and assay.Difference factor (f1) values were less than 15 and similarity factor (f2)\nvalues were greater than 50 for all products of glibenclamide.The hypoglycemic effect of different products of glibenclamide tablets\nwas evaluated on normoglycemic mice.The in vivo studies indicated that there is no significant difference in percent reduction of\nblood glucose level between the brands of glibenclamide and the innovator product (p > 0.05). Hence, based on the in vivo results\nand in vitro dissolution studies, the brands might be substituted with the innovator product in clinical practice....
A reversed phase liquid chromatographic method with UV detection at 254 nm for dorzolamide assay in ophthalmic\nsolutions was developed and validated. Chromatographic separation was achieved on a Zorbax SB C18 (250mmÃ? 4.6 mm, ... column kept at ... with an isocratic mixture of mobile phase (phosphate buffer, pH 2.5, and acetonitrile, 90 : 10 v/v)\nat a flow rate of 0.8 mL/min. The method was validated for its specificity, linearity, accuracy, precision, limit of detection,\nlimit of quantification, and robustness based on ICH guidelines. The validation studies revealed satisfactory results. The\nproposed method has been applied for the quantification of dorzolamide in commercial samples. The developed method is\nfast, simple, specific, accurate, and sensitive, hence can be applied for routine quality control analysis of dorzolamide in\npharmaceutical dosage form....
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