1. Development and Validation of an UV Spectrophotometric Method of Quantification of Fluconazole Reference
Gereltuya DORJ ; Sarnaizul ERDENEBAATAR ; Zoljargal SAMBUU ; Nomin-Erdene TSOLMON ; School of Pharmacy and Biomedicine, MNUMS, United family, Intermed hospital,National second hospita
Mongolian Pharmacy and Pharmacology 2016;9(2):11-15
Introduction: A UV-spectrophotometric method has been developed for the quantitative estimationof fluconazole. The present study describes development and validation of UV-spectroscopicmethod for estimation of fluconazole reference substance and validation of detection method.Method: During development of analytical method HCl: water (6 different concentrations).The detection length (cmax) was found to be 260nm. Calibration curves were prepared. The proposedmethod obeys Beer’s law in the range of 5-50mkg/ml. Absorption maxima was determinedwith 10 mkg/ml by scanning in the range of 200-400nm.Results: Percent recovery studies are in the range of 95,12%-101.89%. The method was validatedin terms of specificity, linearity, accuracy, range, precision, repeatability, robustness, stabilityof analytical solution. Results of analysis were validated statistically and by specificity studies.From that it was observed that there is no interference of blank, excipients during the estimationof reference substance in formulation.Conclusion: This shows the adaptability of the method for routine estimation of fluconazolereference. Keywords: Fluconazole, method development, validation, spectrophotometry
2.Development and Validation of an UV Spectrophotometric Method of Quantification of Fluconazole Reference
Gereltuya Dorj ; Sarnaizul Erdenebaatar ; Zoljargal Sambuu ; Nomin-Erdene Tsolmon ; School of Pharmacy and Biomedicine, MNUMS, United family, Intermed hospital,National second hospita
Mongolian Pharmacy and Pharmacology 2016;9(2):11-15
Introduction: A UV-spectrophotometric method has been developed for the quantitative estimation
of fluconazole. The present study describes development and validation of UV-spectroscopic
method for estimation of fluconazole reference substance and validation of detection method.
Method: During development of analytical method HCl: water (6 different concentrations).
The detection length (cmax) was found to be 260nm. Calibration curves were prepared. The proposed
method obeys Beer’s law in the range of 5-50mkg/ml. Absorption maxima was determined
with 10 mkg/ml by scanning in the range of 200-400nm.
Results: Percent recovery studies are in the range of 95,12%-101.89%. The method was validated
in terms of specificity, linearity, accuracy, range, precision, repeatability, robustness, stability
of analytical solution. Results of analysis were validated statistically and by specificity studies.
From that it was observed that there is no interference of blank, excipients during the estimation
of reference substance in formulation.
Conclusion: This shows the adaptability of the method for routine estimation of fluconazole
reference. Keywords: Fluconazole, method development, validation, spectrophotometry
3.Ensuring access to COVID-19 therapeutics in Pacific island countries and areas
Gereltuya Dorj ; Eva Mata Martinez ; Karen Hammad ; Biniam Getachew Kabethymer ; Nuha Mahmoud
Western Pacific Surveillance and Response 2023;14(2):14-20
Problem: As of November 2022, over 417 397 confirmed cases and 2631 deaths related to coronavirus disease (COVID-19) were reported in Pacific island countries and areas (PICs). Most PICs have faced challenges accessing therapeutics recommended for the treatment of COVID-19 due to their high demand worldwide and supply chain constraints.
Context: The World Health Organization (WHO) coordinates and provides tailored technical and operational support to 21 PICs. Since the start of the pandemic, WHO has worked with partners to establish a mechanism to ensure equitable access to three novel COVID-19 therapeutics (tocilizumab, molnupiravir and nirmatrelvir/ritonavir) for lower-income countries, including 11 eligible PICs.
Action: WHO coordinated the requests, procurement and distribution of the three novel therapeutics. In addition, WHO supported PICs by providing trainings in clinical management of COVID-19, developing critical supply needs estimates, and facilitating regulatory approval of clinical therapeutics, including emergency use authorization.
Lessons learned: The main barriers to procurement of novel COVID-19 therapeutics were identified as prolonged negotiations with licence holders, sourcing funding, the high cost of therapeutics and limited capacity to provide safety monitoring.
Discussion: Uninterrupted supply and availability of essential medicines in the Pacific region is dependent on external and local sourcing. To overcome procurement barriers and ensure access to novel COVID-19 therapeutics in PICs, WHO‘s pandemic support to Member States focused on strengthening regulatory requirements, safety monitoring and supply chain activities.