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Nov 2017 DOI 10.14302/issn.2324-7339.jcrhap-17-1679
Background: Point-of-care diagnostic tests (POCTs) are increasingly used in both developing and developed countries. They allow same day testing and treatment at remote locations where no laboratory support is available. Quality control measures, which are routinely used in laboratories, have not been widely implemented for POCTs. This aimed to assess the integrity of the entire laboratory testing process, and aims to educate and improve performance in quality of HIV rapid testing. Methods: A health facility based cross section study was conducted from April to June 2016.Randomly selected health facilities were participated in the external quality assessment. Onsite evaluation and panel test were used to collect data using structured checklists and formats. Data was entered and analyzed using SPSS version 16. Results: Between April to June 2016, a total of 60 health facilities (145 testing points) from governmental health facilities (hospitals and health centers) were participated in the study. Among the participated testing points 41% have no designated area, 40% have no clean water for hand washing and 51% have no national test algorithm. The average performance of testing points was varies from 89.6% to 99.1% (Laboratory 99.1%, ANC 90.4%, TB clinic 91.4% and VCT 89.6%). In a multivariable logistic regression model, didn’t follow national testing algorithm to report client test results have statistical significance. Conclusions: High quality test results underpin accurate diagnosis and appropriate treatment for patients. But in the study area the score of proficiency testing result and coverage of training is slightly low comparing to other findings. Therefore following national testing algorithm to report client test results, training and monitoring are critical points to improve the proficiency testing score of testing points.
Jun 2017 DOI 10.14302/issn.2377-2549.jndc-17-1439
The effectiveness of atorvastatin calcium in lowering cholesterol is dose-related. It is available in 10, 20, 40, and 80 mg film coated tablets. In order to ensure quality, safety and efficacy of tablets in formulations, the objective of this presented work was to develop a new high performance liquid chromatographic-UV method for quantitation of active atorvastatin calcium in pharmaceutical formulations. The method was based on reversed-phase high performance liquid chromatographic-UV separation of atorvastatin at detection wavelength of 246 nm using Acclaim 120 C18 reversed phase LC column (5 mm, 250×4.6 mm) with mobile phase of acetonitrile-dichloromethane-acetic acid (68.6: 30.6: 0.8 v/v/v) at a flow rate of 1.0 mL min-1 at 25°C. Different variables affecting chromatographic separation were carefully studied and optimized. The study results provided chromatogram of atorvastatin with retention time of 2.68 min. The calibration curve was linear over the concentration range of 15-300 mg mL-1. No interference was observed from common pharmaceutical excipients present in dosage forms. The proposed method was successfully applied to the determination of atorvastatin calcium in pharmaceutical formulations and proved to be significantly not different with reference method. The proposed can be used as an alternate method for routine quality control analysis of active atorvastatin in research, hospitals and pharmaceutical laboratories.
Feb 2014 DOI 10.14302/issn.2328-0182.japst-13-206
The purpose of this study was to investigate the effect of cremophor RH-40 and polysorbate 80 with hydroxypropyl methylcellulose (HPMC) F4M on the development of formulations of intranasal erythropoietin with low sialic acid content (Neuro-EPO) as a neuroprotective agent. Parameters such as pH, osmolality, apparent viscosity, and protein concentration were controlled for minimizing the differences between formulations. All Neuro-EPO formulations showed similar behaviour in the physicochemistry quality control. However significant differences between formulations were observed in the permanent unilateral ischemia model. The formulations and the vehicles containing cremophor RH-40 showed higher neurotoxicity levels than those containing polysorbate 80 as a nonionic surfactant. Formulations containing HPMC F4M at 0.6% as a bioadhesive polymer showed higher levels of survival and better neurological status than those without the polymer. The formulations with polysorbate 80 and HPMC F4M showed a higher index of survival, smaller incidence of clinical signs of stroke, and similar behavior in the learning and the memory to the false injured animals used as control. These findings suggest that the intranasal pathway constitutes a safe and alternative route of access of the Neuro-EPO to the brain.
Mar 2013 DOI 10.14302/issn.2328-0182.japst-12-173
A reliable, selective and sensitive liquid chromatography-tandem mass spectrometry (LC-ESI-MS/MS) assay has been proposed for the determination of febuxostat in human plasma using indomethacin as the internal standard (IS). The analyte and IS were extracted from 200 µL of human plasma via liquid-liquid extraction using methyl tert-butyl ether. Chromatography was performed on Hypurity C18 (100 mm × 4.6 mm, 5 µm) column under isocratic conditions. Detection of analyte and IS was done by tandem mass spectrometry, operating in negative ionization and multiple reaction monitoring mode. The deprotonated precursor to product ion transitions monitored for febuxostat and indomethacin were m/z 315.1 →271.0 and 356.1→312.0 respectively. The limit of detection (LOD) and limit of quantitation (LOQ) of the method were 0.0025 µg/mL and 0.05 µg/mL respectively. The linear dynamic range validated for febuxostat was 0.05-6.00 µg/mL. The intra-batch and inter-batch precision (% CV) was ≤ 7.1 % while the mean extraction recovery was > 87 % for febuxostat across quality control levels. The method was successfully applied to a bioequivalence study of 80 mg febuxostat tablet formulation in 14 healthy Indian male subjects under fasting and fed condition. The reproducibility in the measurement of study data was demonstrated by reanalysis of 110 incurred samples.