A need for clearer terminology and guidance in the role of reference materials in method development and validation

2003 ◽  
Vol 8 (3-4) ◽  
pp. 108-112 ◽  
Author(s):  
N. Majcen
2021 ◽  
Vol 18 ◽  
Author(s):  
Rishabh Verma ◽  
M. Faiz Arshad ◽  
Parul Grover ◽  
Jasmeet Kaur ◽  
Neha Gandhi ◽  
...  

Abstract: Iridoids are monoterpenoids classed with a cyclopentanopyran framework and are detected in various plants and certain special animals. In plants, it exists as glycosides, generally bound to glucose. Around six hundred iridoid glycosides are available in fifty-seven families of plants. Iridoids are abundant in dicotyledonous plants belonging to the Diervillaceae, Loganiaceae, Apocynaceae, Scrophulariaceae, Lamiaceae, and Rubiaceae families. Analytical techniques like chromatography, NMR, UPLC, etc., are used for the identification, separation, and estimation of either herbal extracts or formulations of iridoids. Advanced analytical techniques are very useful for precise and accurate quantification of active ingredients that are responsible for therapeutic effects, and they can be achieved by a developed and validated robust analytical method. Iridoids have shown diverse pharmacological properties. Some of the important activities are immunomodulatory, neuroprotective, anti-inflammatory, hepatoprotective, and cardio-protective effects. The other important activities are antimicrobial, antioxidant, hypoglycemic, hypolipidemic, anticancer, choleretic, antispasmodic, and purgative activities attributed to iridoids. There were not many efforts made in the past to gather and review the literature on various aspects of iridoids. This review article has collected a myriad of literature on old and advanced analytical techniques, including method development and validation of methods for quantitative and qualitative analysis of iridoids. The review also emphasizes the role of iridoids in the prevention of various ailments.


2019 ◽  
Vol 15 (5) ◽  
pp. 591-598 ◽  
Author(s):  
Haitham Alrabiah ◽  
Ahmed Bakheit ◽  
Sabray Attia ◽  
Gamal A.E. Mostafa

Background: Conivaptan inhibits two of vasopressin receptor (vasopressin receptor V1a and V2). Conivaptan is used for the treatment of hyponatremia, and in some instances, for the treatment of the heart failure. Methods: The present study aimed to develop a simple, sensitive, and accurate HPLC with ultraviolet detection for the assay of conivaptan (CON) in mouse plasma using bisoprolol as internal standard (IS). A precipitation procedure was used to extract CON and the IS from the mouse plasma. CON was chromatographically separated using a C18 analytical column at 25°C. The separation was carried out using a mixture of phosphate buffer (50 mM): acetonitrile (60: 40, v/v, pH 4.5) with a flow rate of 1.0 mL/min and detection was performed at 240 nm. Results: The assay was validated according to the US Food and Drug (FDA) guidelines. The method demonstrated linearity over a concentration range of 150 - 2000 ng/mL (correlation coefficient: r 2 = 0.9985). The mean recovery of CON from the mouse plasma was 101.13%. All validation parameters for CON were within the acceptable range. Conclusion: The investigated method has been shown to be suitable for estimating the CON in plasma samples, and this method is sensitive and highly selective, allowing the estimation of its concentrations up to the nano-scale. The suggested method was successfully used in a pharmacokinetic study of CON in mouse plasma.


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