A validated specific stability-indicating reverse-phase liquid chromatographic method was developed for the quantitative determination of Ambrisentan as well as its related substances in bulk samples, pharmaceutical dosage forms in the presence of degradation products and its related impurities. Forced degradation studies were performed on bulk samples of Ambrisentan as per the ICH-prescribed stress conditions using acid, base, oxidative, thermal stress and photolytic degradation to show the stability-indicating power of the LC method. Significant degradation in acidic, basic stress conditions was observed and no degradation was observed in other stress conditions. The chromatographic method was optimized using the samples generated from the forced degradation studies and the impurity-spiked solution. Good resolution between the peaks corresponds to Ambrisentan-related impurities and degradation products from the analyte were achieved on a SunFire C18 column using a mobile phase consisting of a mixture of potassium dihydrogen orthophosphate at a pH adjusted to 2.5 with ortho-phosphoric acid in water and a mixture of acetonitrile:methanol using a simple linear gradient. The detection was carried out at 225 nm. The limit of detection and the limit of quantification for the Ambrisentan and its related impurities were established. The stressed test solutions were assayed against the qualified working standard of Ambrisentan and the mass balance in each case was between 98.9 and 100.3%, indicating that the developed LC method was stability indicating. Validation of the developed LC method was carried out as per the ICH requirements. The developed method was found to be suitable to check the quality of bulk samples of Ambrisentan at the time of batch release and also during its storage (long-term and accelerated stability).
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1093/chromsci/bmt121 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Single-cell phenotyping of extracellular electron transfer via microdroplet encapsulation.
Appl Environ Microbiol
January 2025
McKetta Department of Chemical Engineering, The University of Texas at Austin, Austin, Texas, USA.
Electroactive organisms contribute to metal cycling, pollutant removal, and other redox-driven environmental processes via extracellular electron transfer (EET). Unfortunately, developing genotype-phenotype relationships for electroactive organisms is challenging because EET is necessarily removed from the cell of origin. Microdroplet emulsions, which encapsulate individual cells in aqueous droplets, have been used to study a variety of extracellular phenotypes but have not been applied to investigate EET.
View Article and Find Full Text PDFInvestigating the impact of microbiome-changing interventions on food decision-making: MIFOOD study protocol.
BMC Nutr
January 2025
Clinic for Cognitive Neurology, University of Leipzig Medical Center, Leipzig, Germany.
Background: Obesity is a multifactorial disease reaching pandemic proportions with increasing healthcare costs, advocating the development of better prevention and treatment strategies. Previous research indicates that the gut microbiome plays an important role in metabolic, hormonal, and neuronal cross-talk underlying eating behavior. We therefore aim to examine the effects of prebiotic and neurocognitive behavioral interventions on food decision-making and to assay the underlying mechanisms in a Randomized Controlled Trial (RCT).
View Article and Find Full Text PDF[Mini-barcode combined with ITS2 for identification of bulk Artemisiae Scopariae Herba].
Zhongguo Zhong Yao Za Zhi
December 2024
State Key Laboratory of Chinese Medicine Modernization, Tianjin University of Traditional Chinese Medicine Tianjin 301617, China.
Artemisiae Scoporiae Herba is derived from Artemisia scoparia or A. capillaris. The accurate identification of the herbs, particularly when dealing with bulk samples, is critical for ensuring the quality and efficacy of the medicinal product.
View Article and Find Full Text PDFDiffusion coefficient measurements for moving samples under strong magnetic field gradients.
J Magn Reson
January 2025
São Carlos Institute of Physics, University of São Paulo São Carlos São Paulo Brazil.
Among the numerous measurements carried out during a well-logging procedure, the Nuclear Magnetic Resonance (NMR) assessment is one of the fundamental analyses in determining the economic viability of a well for the oil industry. Nowadays, two reliable approaches, Wireline Logging (WL) and Logging While Drilling (LWD), stand out. WL comprises the acquisition of NMR data under static conditions.
View Article and Find Full Text PDFSaline Lavage for Sampling of the Canine Nasal Immune Microenvironment.
J Vis Exp
December 2024
Department of Clinical Sciences, College of Veterinary Medicine and Biomedical Sciences, Colorado State University.
Evaluating the local immune microenvironment of the canine nasal cavity can be important for investigating normal tissue health and disease conditions, particularly those associated with local inflammation. We have optimized a technique to evaluate the local nasal immune microenvironment of dogs via serial nasal lavage. Briefly, with dogs under anesthesia and positioned in sternal recumbency, prewarmed sterile saline is flushed into the affected nostril using a flexible soft rubber catheter.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!