Current Issue : July - September Volume : 2020 Issue Number : 3 Articles : 5 Articles
An IVRT method was developed and validated to confirm its reproducibility, precision,\nsensitivity, selectivity, accuracy, robustness, and reliability. A novel approach was used to demonstrate\nthe appropriateness of the IVRT method to accurately assess â??samenessâ? between topical products\nand to confirm that the methodology applied also possesses the requisite discriminatory power to\ndetect differences should such differences exist between products. In the first instance, the reference\nproduct (Metrocreme®) containing 0.75% metronidazole (MTZ) was tested against itself as a positive\ncontrol, to accurately demonstrate â??samenessâ?, where the results met the relevant acceptance criteria\nfalling within the limits of 75â??133.33% in accordance with the FDAâ??s SUPAC-SS guidance. In addition,\ntwo specially prepared creams containing 25% less and 26% more MTZ, i.e., 0.563% and 0.945%,\nserved as negative controls and were compared...............
Acrylamide (AA) is a carcinogenic substance found in food, cigarette smoke and in an environment exposed to acrylamide. This\nstudy aims to analyze AA levels in dried blood spot (DBS) samples of lung cancer patients with smoking record, without smoking\nrecord, and also in the negative blank. Analysis of AA levels was determined by liquid chromatography tandem mass spectrometry\n(LC-MS/MS) and DBS extraction using protein precipitation techniques. Mass detection was done using positive electron spray\nionization (ESI) and multiple reaction monitoring (MRM) type with m/z values of 71.99 > 55.23 for acrylamide and m/z\n260.16 > 116.04 for propranolol as the internal standard. AA levels in lung cancer patients with smoking record is in the range of...........................
Considering the recent regulatory requirements, the overall importance of in vitro release\ntesting (IVRT) methods regarding topical product development is undeniable, especially when\naddressing particulate systems. For each IVRT study, several hundreds of samples are generated.\nTherefore, developing rapid reversed-phase high-performance liquid chromatography (RP-HPLC)\nmethods, able to provide a real-time drug analysis of IVRT samples, is a priority. In this study,\neight topical complex drug products exhibiting distinct physicochemical profiles were considered.\nRP-HPLC methods were developed and fully validated. Chromatographic separations were achieved................
Sojadodamgangki-tang (SDGT) is a traditional Korean medicine consisting of 12 medicinal\nherbs that has been used in Korea for the treatment of asthma since ancient times. However,\nthe quality control of herbal formulas that contain two or more herbal medicines remains\nchallenging. In this study, 14 marker components were analyzed simultaneously by using\nhigh-performance liquid chromatography with photodiode array detection in addition to the use of\nliquid chromatographyâ??tandem mass spectrometry for quality evaluation of SDGT. The simultaneous\ndetermination of the 14 marker components was validated in terms of linearity, recovery, and precision.\nThe established methods can provide useful data for the quality control of SDGT and related\nherbal formulas....
Different signal-transforming algorithms were applied for UV spectrophotometric analysis of paracetamol, ibuprofen, and\ncaffeine in ternary mixtures. Phosphate buffer pH 7.2 was used as the spectrophotometric solvent. Severe overlapping spectra\ncould be resolved into individual bands in the range of wavelengths 200-300nm by using Savitzkyâ??Golay smoothing and\ndifferentiation, trigonometric Fourier series, and mother wavelet functions (i.e., sym6, haar, coif3, and mexh). To optimize spectral\nrecoveries, the concentration of various types of divisors (single, double, and successive) was tested. The developed spectrophotometric\nmethods showed linearity over the ranges.......................
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