A novel validated UHPLC method for the estimation of rosuvastatin and its complete impurity profile in tablet formulations

A key step in the development of medicinal products is the research and validation of selective and sensitive analytical methods for the control of impurities from synthesis and degradation. As most impurities are similar in structure to the drug substance, the achievement of chemo-selective conditions is usually challenging. Herein, a direct and highly selective ultra-high-performance liquid chromatographic method for determining the assay and related substances content in medicinal products containing rosuvastatin calcium salt (RSV) is presented. RSV is used to treat high cholesterol levels and prevent heart attacks and strokes. The most engaging feature of this method was the baseline separation of all organic related substances listed in the European Pharmacopoeia (EP) monograph for the RSV tablets, achieved for the first time in less than 15 min using the Acquity BEH C18 (100 mm × 2.1 mm, 1.7 μm) column under reversed-phase isocratic conditions. The mobile phase adopted for the chemo-selective analysis does not contain buffers but instead contains trifluoroacetic as an acid additive. The chromatographic method was validated according to the guidelines of the International Conference on Harmonization (ICH) and proved to be linear, precise and accurate for determining the content of RSV and related chiral substances in tablet formulations

Unilateral congenital elongation of the cervical part of the internal carotid artery with kinking and looping: two case reports and review of the literature

Unilateral and bilateral variation in the course and elongation of the cervical (extracranial) part of the internal carotid artery (ICA) leading to its tortuosity, kinking and coiling or looping is not a rare condition, which could be caused by both embryological and acquired factors. Patients with such variations may be asymptomatic in some cases; in others, they can develop cerebrovascular symptoms due to carotid stenosis affecting cerebral circulation. The risk of transient ischemic attacks in patients with carotid stenosis is high and its surgical correction is indicated for the prevention of ischemic stroke. Detection of developmental variations of the ICA and evaluation of its stenotic areas is very important for surgical interventions and involves specific diagnostic imaging techniques for vascular lesions including contrast arteriography, duplex ultrasonography and magnetic resonance angiography. Examination of obtained images in cases of unusual and complicated variations of vascular pattern of the ICA may lead to confusion in interpretation of data. Awareness about details and topographic anatomy of variations of the ICA may serve as a useful guide for both radiologists and vascular surgeons. It may help to prevent diagnostic errors, influence surgical tactics and interventional procedures and avoid complications during the head and neck surgery. Our present study was conducted with a purpose of updating data about developmental variations of the ICA. Dissections of the main neurovascular bundle of the head and neck were performed on a total 14 human adult cadavers (10 – Africans: 7 males & 3 females and 4 – East Indians: all males). Two cases of unilateral congenital elongation of the cervical part of the ICA with kinking and looping and carotid stenoses were found only in African males. Here we present their detailed case reports with review of the literature

Insight from an Italian Delphi Consensus on EVAR feasibility outside the instruction for use: the SAFE EVAR Study

BACKGROUND: The SAfety and FEasibility of standard EVAR outside the instruction for use (SAFE-EVAR) Study was designed to define the attitude of Italian vascular surgeons towards the use of standard endovascular repair (EVAR) for infrarenal abdominal aortic aneurysm (AAA) outside the instruction for use (IFU) through a Delphi consensus endorsed by the Italian Society of Vascular and Endovascular Surgery (Societa Italiana di Chirurgia Vascolare ed Endovascolare - SICVE). METHODS: A questionnaire consisting of 26 statements was developed, validated by an 18 -member Advisory Board, and then sent to 600 Italian vascular surgeons. The Delphi process was structured in three subsequent rounds which took place between April and June 2023. In the first two rounds, respondents could indicate one of the following five degrees of agreement: 1) strongly agree; 2) partially agree; 3) neither agree nor disagree; 4) partially disagree; 5) strongly disagree; while in the third round only three different choices were proposed: 1) agree; 2) neither agree nor disagree; 3) disagree. We considered the consensus reached when >70% of respondents agreed on one of the options. After the conclusion of each round, a report describing the percentage distribution of the answers was sent to all the participants. RESULTS: Two -hundred -forty-four (40.6%) Italian Vascular Surgeons agreed to participate the first round of the Delphi Consensus; the second and the third rounds of the Delphi collected 230 responders (94.3% of the first -round responders). Four statements (15.4%) reached a consensus in the first rounds. Among the 22 remaining statements, one more consensus (3.8%) was achieved in the second round. Finally, seven more statements (26.9%) reached a consensus in the simplified last round. Globally, a consensus was reached for almost half of the proposed statements (46.1%). CONCLUSIONS: The relatively low consensus rate obtained in this Delphi seems to confirm the discrepancy between Guideline recommendations and daily clinical practice. The data collected could represent the source for a possible guidelines' revision and the proposal of specific Good Practice Points in all those aspects with only little evidence available

Iatrogenic pseudoaneurysms of the peripheral arteries

The aim of the study was to report our clinical experience with the surgical treatment of iatrogenic pseudoaneurysms of the peripheral arteries. The study is a retrospective review of 101 consecutive patients (52 males, 49 females, mean age 66.2 years, range 33-86), with iatrogenic pseudoaneurysms of the peripheral arteries, surgically treated in a vascular unit from October 1990 to June 2006. Duplex ultrasound scanning was employed to support the clinical findings. The surgical treatment consisted in direct closure with polypropylene sutures and, occasionally, patch angioplasty or bypass. Ultrasound compression was effective in one of 4 small aneurysms (< 2.5). No limb loss occurred. There were 4 wound complications (3.9%), one pulmonary embolism (0.99%), and 3 deaths (2.9%), 2 of which not related to vascular repair and one secondary to femoral endoarteritis and septic shock, unrelated to previous implantation of a percutaneous femoral closure device. Although iatrogenic pseudoaneurysms of the peripheral arteries are rarely observed in clinical practice, a significant number of peripheral artery complications may occur after cardiac catheterisation and coronary angioplasty. Failure of conservative treatment requires a traditional surgical repair. The results of our series included a significant mortality rate (2.9%), resulting from the severity of cardiac disease in 2 cases and from the vascular repair itself in one case (femoral endoarteritis). These results substantiate the common observation that patients who require surgery for an iatrogenic pseudoaneurysm are often affected by advanced cardiovascular disease and are liable to suffer the occurrence of complications, with a high risk of death. Therefore, any surgical treatment should be performed with strict adherence to sound vascular surgical principles

Iatrogenic pseudoaneurysms of the peripheral arteries

The aim of the study was to report our clinical experience with the surgical treatment of iatrogenic pseudoaneurysms of the peripheral arteries. The study is a retrospective review of 101 consecutive patients (52 males, 49 females, mean age 66.2 years, range 33-86), with iatrogenic pseudoaneurysms of the peripheral arteries, surgically treated in a vascular unit from October 1990 to June 2006. Duplex ultrasound scanning was employed to support the clinical findings. The surgical treatment consisted in direct closure with polypropylene sutures and, occasionally, patch angioplasty or bypass. Ultrasound compression was effective in one of 4 small aneurysms (< 2.5). No limb loss occurred. There were 4 wound complications (3.9%), one pulmonary embolism (0.99%), and 3 deaths (2.9%), 2 of which not related to vascular repair and one secondary to femoral endoarteritis and septic shock, unrelated to previous implantation of a percutaneous femoral closure device. Although iatrogenic pseudoaneurysms of the peripheral arteries are rarely observed in clinical practice, a significant number of peripheral artery complications may occur after cardiac catheterisation and coronary angioplasty. Failure of conservative treatment requires a traditional surgical repair. The results of our series included a significant mortality rate (2.9%), resulting from the severity of cardiac disease in 2 cases and from the vascular repair itself in one case (femoral endoarteritis). These results substantiate the common observation that patients who require surgery for an iatrogenic pseudoaneurysm are often affected by advanced cardiovascular disease and are liable to suffer the occurrence of complications, with a high risk of death. Therefore, any surgical treatment should be performed with strict adherence to sound vascular surgical principles