Stability indicating HPLC method for simultaneous determination of candesartan cilexetil and hydrochlorothiazide in pharmaceuticals
Issued Date
2014
Copyright Date
2014
Resource Type
Language
eng
File Type
application/pdf
No. of Pages/File Size
xiv, 95 leaves : ill.
Access Rights
open access
Rights
ผลงานนี้เป็นลิขสิทธิ์ของมหาวิทยาลัยมหิดล ขอสงวนไว้สำหรับเพื่อการศึกษาเท่านั้น ต้องอ้างอิงแหล่งที่มา ห้ามดัดแปลงเนื้อหา และห้ามนำไปใช้เพื่อการค้า
Rights Holder(s)
Mahidol University
Bibliographic Citation
Thesis (M.Sc. (Pharmaceutical Chemistry))--Mahidol University, 2014
Suggested Citation
Phan, Thi Nhu Quynh, 1988- Stability indicating HPLC method for simultaneous determination of candesartan cilexetil and hydrochlorothiazide in pharmaceuticals . Thesis (M.Sc. (Pharmaceutical Chemistry))--Mahidol University, 2014. Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/95239
Title
Stability indicating HPLC method for simultaneous determination of candesartan cilexetil and hydrochlorothiazide in pharmaceuticals
Author(s)
Advisor(s)
Abstract
A simple and specific HPLC method was developed for simultaneous determination of candesartan cilexetil and hydrochlorothiazide in pharmaceuticals. Method development was performed by using a Zobax SB CN column (4.6x150 mm, 5μm). The optimum conditions were in a mixture of acetonitrile and 10 mM phosphate buffer (pH 7.0, 32:68, v/v) with a flow rate of 1 mL/min, the column temperature at 25oC, and the UV detection at 254 nm. Hydrochlorothiazide and candesartan cilexetil were eluted at 2.65 and 8.21 min, respectively. The method was validated for linearity and range, accuracy, precision, and specificity according to ICH guidelines. Linearity was obtained in the range of 50 to 150% of target concentrations. Percent recovery was in the range of 99.1% to 101.0% for candesartan cilexetil and 99.4% to 100.2% for hydrochlorothiazide. The %RSD of intra- and inter-day precision for both drugs was less than 1.66% and 1.84%, respectively. A stability study of candesartan cilexetil and hydrochlorothiazide was conducted using the developed and validated HPLC method. The method proved to be stability indicating as it can analyze the drugs in the presence of their degradation products with a resolution of the critical peak pair of 1.5 and peak purity values of more than 990. The drugs were stressed under acid/base/neutral hydrolysis, oxidation, photolysis, and thermal degradation. Candesartan cilexetil was stable under neutral (water) hydrolysis, photolysis, and thermal degradation, but it degraded under acid (0.1 N HCl) and base (0.1 N NaOH) hydrolysis, and oxidation (30% H2O2). Similarly, hydrochlorothiazide was stable under oxidation (30% H2O2), photolysis, and thermal degradation, but it degraded under neutral, acid (1 N HCl), and base (1 N NaOH) hydrolysis. The method was successfully applied to analyze commercial drug products with %RSD of five replication of less than 0.80%.
Description
Pharmaceutical Chemistry (Mahidol University 2014)
Degree Name
Master of Science
Degree Level
Master's degree
Degree Department
Faculty of Pharmacy
Degree Discipline
Pharmaceutical Chemistry
Degree Grantor(s)
Mahidol University