Pregled bibliografske jedinice broj: 571492
Development and validation of a method for the determination of heparin in cream
Development and validation of a method for the determination of heparin in cream // Četvrti hrvatski kongres farmacije
Opatija, Hrvatska, 2010. (poster, domaća recenzija, sažetak, znanstveni)
CROSBI ID: 571492 Za ispravke kontaktirajte CROSBI podršku putem web obrasca
Naslov
Development and validation of a method for the determination of heparin in cream
Autori
Valentić, Iva ; Štanfel, Danijela ; Špoljarić, Gordana ; Štucl, Marijana
Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni
Skup
Četvrti hrvatski kongres farmacije
Mjesto i datum
Opatija, Hrvatska, 27.05.2010. - 30.05.2010
Vrsta sudjelovanja
Poster
Vrsta recenzije
Domaća recenzija
Ključne riječi
razvoj; validacija; heparin; krema
(development; validation; heparin; cream)
Sažetak
Heparin is an anticoagulant that prevents the formation of clots and extension of existing clots by increasing activity of enzyme inhibitor antithrombin III who than inactivates trombin and other proteases involved in blood clotting. The purpose of this study was to develop and validate method for the assay of heparin in cream preparation. The anticoagulant activity of heparin is determined in vitro by comparing its ability to prolong the clotting of plasma with the same ability of a reference preparation of heparin calibrated in International Units. The extraction step of heparin from cream samples involves a treatment procedures based on warming, cooling and centrifugation to assure the elimination of the lipophilic matrix component. The prepared solution is added to plasma and activated partial thromboplastin times (APTT) is measured on coagulometer DIAcheck C4. Photometric recording of the change in optical density was used to onset of clotting of plasma. The potency of heparin is calculated by statistical method, parallel line model. The developed method was linear over the concentration range of 0.256 – 0.625 IU/ml with acceptable correlation coefficient of ≥ 0.985. The accuracy was within the 5% bias (98.4 – 103.0%). Repeatability yielded coefficients of variation (CV) of less then 5% (0.87%) and intermediate precision provided CV values of less than 10% (0.94%). The method validation study proven that the method is accurate and precise and there for suitable for quality control and stability testing of heparin in cream formulation.
Izvorni jezik
Engleski
Znanstvena područja
Farmacija
