Development and Validation of a Novel Stability Indicating Reverse Phase High Performance Liquid Chromatographic Method for Related Substances and Assay Analysis of Molnupiravir Drug Substance and Drug Product

Molnupiravir, a broad-spectrum antiviral is an isopropyl ester prodrug of beta-D-N4-hydroxycytidine. Molnupiravir targets RNA-dependent RNA-polymerase enzyme of the viruses. A new stability-indicating HPLC-method was developed to determine related substances and assay of molnupiravir. Separation was achieved by using Shim-pack GWS C18 column. The method was validated according to current ICH requirements. The calibration plot gave a linear relationship for all known analytes over the concentration range from LOQ to 200%. LOD and LOQ for all known analytes were found in 0.05-0.08 microg mL-1 and 0.12-0.20 microg mL-1, respectively, the mean recovery was found to be 97.79-102.44 %. Study showed that the method, results of robustness, solution stability studies are precise and within the acceptable limits. Molnupiravir was found to degrade in acid, alkali, and oxidative conditions, and was stable in thermal, moisture, and photolytic degradation condition. The method is simple, accurate, precise, and reproducible for routine purity analysis of drug-samples.Copyright © 2022 Indian Drug Manufacturers' Association. All rights reserved.

Beyond Cultural Competence: Addressing Mental Health Needs in Youth of Color, Immigrant, Lgbt, and Refugee Populations in Schools

Objectives: The current pandemic has disproportionately affected the mental health of already-vulnerable young people: youth of color, immigrant, LGBTQ+, and refugee populations, and others who traditionally experience healthcare inequities. Financial hardships, systemic discrimination, cultural stigma, and lack of skilled practitioners are among the numerous global barriers to youth mental health and culturally competent care. Importantly, vulnerable populations have particularly limited access to mental health care, yet most continue to attend some form of school in person or virtually. Child and adolescent psychiatrists are uniquely positioned to transform these barriers by partnering with schools to provide culturally sensitive mental health services. Method(s): After the panel introduction, a brief review of the impact of COVID-19 and systemic discrimination on the mental health of youth will be presented by Kristie Ladegard, MD, and Anna Ordonez, MD, MAS (8 minutes). Presenters (18 minutes each) will discuss their specific school-based mental health service (SBMHS) initiatives and outcomes, including unique vulnerabilities, stigmas, and barriers that their patient populations face: Kristie Ladegard, MD, "Culturally Informed Training: Lessons from Denver School-Based Clinics";Brandon Johnson, MD, "Addressing LGBTQ+-Related Mental Health in Schools";Mina Fazel, MD, "Lessons in Belonging: Tools to Help Refugee Children in Schools";and Jane Ripperger-Suhler, MD, and Puja Patel, PhD, "Reaching At-Risk Youth by Telehealth in Texas: Experience From the Texas Child Health Access Through Telemedicine Program." Shashank Joshi, MD, and Dr. Ordonez, as our discussants, will review each program's cultural dimensions and identify persistent challenges and their solutions (20 minutes), followed by panel questions and answers (20 minutes). Result(s): Models of SBMHS varied in their approach to cultural engagement, health promotion, school partnership, and treatment modalities. All demonstrated successful outcomes with youth who traditionally experience healthcare inequities. Conclusion(s): Providing culturally competent mental health care in school settings is essential to improving health equity to vulnerable and underserved communities. Child and adolescent psychiatrists must lead the way in advocating for culturally competent and evidence-based methods that increase global access to mental health treatment for all youth across the world. DEI, SC, CUL Copyright © 2022

Massive Haemoperitoneum Postovulation: A Rare Complication of Unmonitored Anticoagulant Therapy

Derangements in coagulation profile due to on-going anticoagulant medication can complicate the most primitive physiology in a woman, ovulation. Unmonitored anticoagulant therapy can lead to an array of complications, one of which is intraperitoneal haemorrhage secondary to numerous medical and surgical conditions. The resultant haemoperitoneum can cause sudden hypovolemic shock, especially in a patient with compromised cardiovascular status. This report narrates the case of a 30 years old nulliparous female patient on anticoagulant therapy, operated for multiple cardiac defects and developed massive haemoperitoneum as a consequence of ovulation. The patient presented in shock to the Emergency Department with unstable haemodynamic status. A multi-disciplinary approach to the case converged on ruptured functional ovarian cyst as a working diagnosis. Conservative management of haemoperitoneum was decided upon, whereby correcting shock and providing pro-coagulant therapy along with blood products was the main line of management. All efforts failed soon after when the cyst wall ruptured catastrophically, leading to collapse of the general condition of the patient. Surgical approach was undertaken and a ruptured ovarian cyst wall was identified to be the cause. The cyst wall was subsequently repaired electrosurgically and the patient recovered well with an uneventful postoperative period. However, the characteristic feature of this case is the lack of follow-up due to lockdown restrictions of this continuum, the Coronavirus Disease-2019 (COVID-19) pandemic. The management of such cases must be carefully titrated, keeping in mind the risks and benefits of both pro-coagulant and anti-coagulant therapy wherein one can jeopardise the effects of the other.