Yıl: 2022 Cilt: 9 Sayı: 2 Sayfa Aralığı: 505 - 512 Metin Dili: İngilizce DOI: 10.18596/jotcsa.956110 İndeks Tarihi: 29-07-2022

Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations

Öz:
The development and validation of a novel, simple, and quick HPLC technique for measuring bosentan in pharmaceutical formulations was performed. The technique parameters were tuned to be 1 mL/min flow rate, variable column temperature, and a mobile phase combination of methanol-acetonitrile-water (20:50:30 v/v/v) to carry out this study. All measurements were carried out with a UV detector at a wavelength of 272 nm. Specificity, the limit of quantitation (LOQ), limit of detection (LOD), linearity, accuracy, precision, stability, recovery, and ruggedness were all tested. The technique was linear between 0.25 and 20 µg/mL, with precision (RSD%) and accuracy (RE%) of less than 3.0 and 2.7%, respectively. The LOQ and LOD values of method were 0.25 and 0.1 µg/mL, respectively. The 10 µg/mL of standard bosentan solution was found to be moderately stable in acidic and basic settings (0.1 M HCl and 0.1 M NaOH) but unstable in an oxidative environment (H2O2 solution; 3%). No interference from tablet excipients was observed in the HPLC method. The approach was successfully applied to pharmaceutical formulations obtained from a local pharmacy store.
Anahtar Kelime: HPLC analysis Bioanalytical Method Validation Drug degradation Bosentan

Belge Türü: Makale Makale Türü: Araştırma Makalesi Erişim Türü: Erişime Açık
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APA TURKAN D, YAMAN M, Atila A, KADIOGLU Y (2022). Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations. , 505 - 512. 10.18596/jotcsa.956110
Chicago TURKAN Didar,YAMAN MEHMET EMRAH,Atila Alptug,KADIOGLU Yucel Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations. (2022): 505 - 512. 10.18596/jotcsa.956110
MLA TURKAN Didar,YAMAN MEHMET EMRAH,Atila Alptug,KADIOGLU Yucel Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations. , 2022, ss.505 - 512. 10.18596/jotcsa.956110
AMA TURKAN D,YAMAN M,Atila A,KADIOGLU Y Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations. . 2022; 505 - 512. 10.18596/jotcsa.956110
Vancouver TURKAN D,YAMAN M,Atila A,KADIOGLU Y Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations. . 2022; 505 - 512. 10.18596/jotcsa.956110
IEEE TURKAN D,YAMAN M,Atila A,KADIOGLU Y "Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations." , ss.505 - 512, 2022. 10.18596/jotcsa.956110
ISNAD TURKAN, Didar vd. "Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations". (2022), 505-512. https://doi.org/10.18596/jotcsa.956110
APA TURKAN D, YAMAN M, Atila A, KADIOGLU Y (2022). Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations. Journal of the Turkish Chemical Society, Section A: Chemistry, 9(2), 505 - 512. 10.18596/jotcsa.956110
Chicago TURKAN Didar,YAMAN MEHMET EMRAH,Atila Alptug,KADIOGLU Yucel Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations. Journal of the Turkish Chemical Society, Section A: Chemistry 9, no.2 (2022): 505 - 512. 10.18596/jotcsa.956110
MLA TURKAN Didar,YAMAN MEHMET EMRAH,Atila Alptug,KADIOGLU Yucel Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations. Journal of the Turkish Chemical Society, Section A: Chemistry, vol.9, no.2, 2022, ss.505 - 512. 10.18596/jotcsa.956110
AMA TURKAN D,YAMAN M,Atila A,KADIOGLU Y Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations. Journal of the Turkish Chemical Society, Section A: Chemistry. 2022; 9(2): 505 - 512. 10.18596/jotcsa.956110
Vancouver TURKAN D,YAMAN M,Atila A,KADIOGLU Y Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations. Journal of the Turkish Chemical Society, Section A: Chemistry. 2022; 9(2): 505 - 512. 10.18596/jotcsa.956110
IEEE TURKAN D,YAMAN M,Atila A,KADIOGLU Y "Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations." Journal of the Turkish Chemical Society, Section A: Chemistry, 9, ss.505 - 512, 2022. 10.18596/jotcsa.956110
ISNAD TURKAN, Didar vd. "Stability Indicating RP-HPLC Method Development and Validation for Bosentan in Pharmaceutical Formulations". Journal of the Turkish Chemical Society, Section A: Chemistry 9/2 (2022), 505-512. https://doi.org/10.18596/jotcsa.956110