Naslov
New method for determination of impurity in Dorzolamide Hydrochloride

Autori
Štanfel, Danijela ; Franić, Dean

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
onečišćenje; dorzolamid
(impurity; dorzolamid)

Sažetak
The HPLC method for determination of Impurity A in active substance, Dorzolamide hydrochloride is described in the Ph.Eur. This method prescribes the use of (S)-(-)-α-methylbenzyl isocyanate as derivatization reagent. Thus, results that are obtained using the Ph. Eur. method are unreliable and precise determination of impurity A in our laboratory becomes difficult. The new chiral HPLC method has been developed for the purposes of reliably determination of Impurity A in Dorzolamide hydrochloride. New parameters of HPLC chromatographic system are: Column ; Chirallica PST-1 ® OD-R column (250 × 4, 6 mm i.d., 5 μm) Mobile phase ; n–hexane : 2–propanol : diethylamine (70 : 30 : 0, 1 v/v/v%) The flow rate ; 1 mL/min Detection ; spectrophotometer at 254 nm (unchanged) The method validation study was carried out according to the validation protocol. The method was validated with satisfactory linearity (R2 ≥ 0, 995), range (0, 1% - 0, 7%), accuracy (98, 9% - 99, 8% ; RSD 0, 24% - 0, 38%), precision, limit of detection (LOD = 0, 005%), limit of quantitation (LOQ = 0, 01%) and robustness. It was concluded that the proposed method gives reproducible, accurate and precise results ; and is appropriate for determination of impurity A in Dorzolamide hydrochloride substance.

Izvorni jezik
Engleski

Znanstvena područja
Kemija, Farmacija

POVEZANOST RADA