Development and validation of a RP-HPLC method for determination of solubility of furosemide
Küçük Resim Yok
Tarih
2013
Yazarlar
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Erişim Hakkı
info:eu-repo/semantics/closedAccess
Özet
The objective of the Biopharmaceutics Classification System is to allow prediction of in vivo pharmacokinetic performance of drug products from in vitro measurements; therefore, it is important to determine the solubility and permeability of drug substances. Furosemide (FSM) is a loop diuretic commonly used in the treatment of edematous states associated chronic renal failure, hypertension, congestive heart failure and cirrhosis of the liver. The aim of this study was to develop and validate an HPLC method for quantification of FSM in the samples obtained from the in vitro solubility studies performed at five different pH values (pH 1.0, 2.9, 3.9, 4.9 and 7.5). Chromatographic separation of FSM was achieved on a reverse phase column (Waters Spherisorb ODS2 C18 250x4.6 mm 5 pim) with a mobile phase consisted of 0.01M KH2P04 (pH 5.5) and methanol (70:30 v/v). Analyses were run at a flow rate 1 mL/min and UV detection was performed at 235 nm. Under these conditions, the retention time of FSM was about 7.0 min. The method was linear in the concentration range of 0.5 to 50 ?/mL, and limit of quantification was 320 ng/mL. Developed and validated HPLC method was proved to be simple, reliable and also suitable as a single method for studying the solubility of FSM as a function of pH. Finally, based on our results, solubility of FSM was dependent on pH. Its solubility was low between pH 1.0 and 4.9, and was high at pH 7.5.
Açıklama
Anahtar Kelimeler
BCS, Dose number, Furosemide, HPLC method, Solubility class
Kaynak
Turkish Journal of Pharmaceutical Sciences
WoS Q Değeri
Scopus Q Değeri
Q3
Cilt
10
Sayı
1
