Uplc method for determination of glibenclamide residual on manufacturing equipment
Journal Title: RA Journal Of Applied Research - Year 2016, Vol 2, Issue 10
Abstract
Pharmaceutical products may be contaminated by various substances such as microbiological contaminants, previous products (residues of active pharmaceutical ingredients and excipients), the residuals of cleaning products and residue generated during the cleaning process, using strong acids and bases, and degradation of detergents, acids and bases that can be used as part of the cleaning process. Requirements of Good Manufacturing Practice include prevention of possible contamination and cross-contamination arising from pharmaceutical starting materials, products, cleaning equipment. Appropriate purification techniques play an important role in the prevention of contamination and cross-contamination. Effective cleaning ensure reduction in the risk of contamination to the lowest acceptable level. Validation confirms the efficiency of the cleaning process, which is necessary to achieve adequate cleanliness of equipment to prevent product contamination. The aim of this work is to present ultra performance liquid chromatography method (UPLC) for determining residues of glibenclamide on production equipment. The optimum results were obtained were: column C-18; 2.1 mm x 50 mm; 1.7 µm, kept at 35°C. The mobile phase was 45% V/V acetoniril, contains 1 ml of phosphoric acid. Flow rate was 0.2 ml/min. UV detection was performed at 230 nm. The method has been validated accordance Guidelines ICH Q2 (R1).
Authors and Affiliations
Larisa Alagić- Džambić
Keywords
Related Articles
- EP ID EP210937
- DOI -
- Views 138
- Downloads 0
Successful Anaesthetic Management Of Moderate Haemophiliaa Patient With Acute Subdural Hematoma Posted For Emergency Craniotomy
Intracranial hemorrhage in patients with haemophilia is associated with high mortality and sequelae. We report the case of 35 year male k/c/o Haemophilia A, who presented with acute subdural hematoma and was posted forem...
Automation Testing In Set Top Box
Set-Top Box (STB) refers to devices that connect to a television and some external broadcasted signal source. It demodulates/converts the broadcasted signal into audio and visual content that can be displayed on a screen...
Pediatric Day Surgery: Evaluating Patient And Parental Anxiety
Objective: A child’s pre-operative anxiety can result in adverse physiological reactions andpostoperative maladaptive behavioral changes. We investigated the child and the parent’s anxiety in response to day surgery and...
Establishing English-Indonesian Bilinguals In Indonesia: From Theory To Practice
For the last two decades the establishment of bilingualism taking English language as one of the target languages has become the main concern of expanding English speaking countries including Indonesia on the grounds tha...
The Needs Of Post-Operative Delirium Assessment Tool For Clinical Nurse
Purpose: postoperative delirium assessment tool (below, tool) for the needs related to, it is to clear by clinical experience life. Methods: the subject nurse 725 people at the National University Hospital 19 Hospital wa...