scholarly journals Cross-validation of a high-performance liquid chromatography nevirapine plasma assay in a resource-limited setting in Zimbabwe

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Faithful Makita-Chingombe ◽  
Anthony T. Podany ◽  
Timothy Mykris ◽  
Farai Muzambi ◽  
Richard W. Browne ◽  
...  

An international HIV pharmacology specialty laboratory (PSL) was established at the University of Zimbabwe to increase bioanalytical and investigator capacities. Quantitation of plasma nevirapine in samples from the AIDS Clinical Trials Group protocol 5279 was compared between the University of Nebraska Medical Center PSL and the University of Zimbabwe PSL. Both PSLs employed internally developed methods utilising reverse-phase high-performance liquid chromatography with ultraviolet detection. Eighty-seven percent of the cross-validation results exhibited ± 20% difference.

HortScience ◽  
2004 ◽  
Vol 39 (6) ◽  
pp. 1220-1223 ◽  
Author(s):  
Rosanna Freyre ◽  
Robert J. Griesbach

Plants of Anagallis monelli in their native habitat or in cultivation have either blue or orange flowers. Clonally propagated cultivars, seed obtained from commercial sources and the resulting plants were grown in a greenhouse at the University of New Hampshire. F2 progeny obtained from hybridization between blue- and orange-flowered plants had blue, orange or red flowers. There were no significant differences in petal pH of orange-, blue-, and red-flowered plants that could explain the differences in flower color. Anthocyanidins were characterized by high-performance liquid chromatography. Results indicated that blue color was due to malvidin, orange to pelargonidin, and red to delphinidin. Based on our segregation data, we propose a three-gene model to explain flower color inheritance in this species.


2011 ◽  
Vol 2011 ◽  
pp. 1-7 ◽  
Author(s):  
Karunanidhi S. Lakshmi ◽  
Tirumala Rajesh

An analytical method based on isocratic reverse phase high-performance liquid chromatography was developed and validated for the separation and quantification of eight antidiabetic drugs: rosiglitazone, pioglitazone, glipizide, gliclazide, repaglinide, nateglinide, glibenclamide, and glimepiride for their application in human plasma assay. Metformin is used as internal standard. Analysis was done on Onyx monolithic C18 column (100×4.6 mm, i.d., 5 μm) using a mixture of 0.05% formic acid in water and methanol in the ratio of 42 : 58 (v/v) fixed at a flow rate of 0.5 mL/min, and they were monitored at 234 nm. Separation was achieved in less than 20 min. The calibration curves were linear in the range of 50–2000 ng/mL. The method was validated for its recovery, intra- and interday precision, stability, specificity, and selectivity. Plasma samples were prepared using solid-phase extraction of analytes. Hence, the developed method was found to be suitable for the routine analysis of selected antidiabetic drugs in biological matrices.


Author(s):  
Takudzwa J. Mtisi ◽  
Charles Maponga ◽  
Tsitsi G. Monera-Penduka ◽  
Tinashe Mudzviti ◽  
Dexter Chagwena ◽  
...  

Background: A growing number of drug development studies that include pharmacokinetic evaluations are conducted in regions lacking a specialised pharmacology laboratory. This necessitated the development of an International Pharmacology Specialty Laboratory (IPSL) in Zimbabwe.Objectives: The aim of this article is to describe the development of an IPSL in Zimbabwe.Methods: The IPSL was developed collaboratively by the University of Zimbabwe and the University at Buffalo Center for Integrated Global Biomedical Sciences. Key stages included infrastructure development, establishment of quality management systems and collaborative mentorship in clinical pharmacology study design and chromatographic assay development and validation.Results: Two high performance liquid chromatography instruments were donated by an instrument manufacturer and a contract research organisation. Laboratory space was acquired through association with the Zimbabwe national drug regulatory authority. Operational policies, standard operating procedures and a document control system were established. Scientists and technicians were trained in aspects relevant to IPSL operations. A highperformance liquid chromatography method for nevirapine was developed with the guidance of the Clinical Pharmacology Quality Assurance programme and approved by the assay method review programme. The University of Zimbabwe IPSL is engaged with the United States National Institute of Allergy and Infectious Diseases Division of AIDS research networks and is poised to begin drug assays and pharmacokinetic analyses.Conclusions: An IPSL has been successfully established in a resource-limited setting through the efforts of an external partnership providing technical guidance and motivated internal faculty and staff. Strategic partnerships were beneficial in navigating challenges leading to laboratory development and training new investigators. The IPSL is now engaged in clinical pharmacology research.


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