Development and validation of new RP-HPLC method for the determination of gliclazide in tablet dosage form
A new sensitive and economic analytical method for the analysis of gliclazide in tablet dosage form was developed and validated using commercial HPLC instrument with modern ultra-performance liquid chromatography column. Samples were analysed using Agilent 1100 Series RP-HPLC equipped with a bina...
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| Format: | Article |
| Language: | English English |
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College of Pharmacists of Buenos Aires Province, Argentina
2017
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| Online Access: | http://irep.iium.edu.my/60341/ http://irep.iium.edu.my/60341/ http://irep.iium.edu.my/60341/1/Latin_American_Journal_of_Pharmacy_36_8_page_1642.pdf http://irep.iium.edu.my/60341/7/60341-Development%20and%20validation%20of%20new%20RP-HPLC%20method%20for%20the%20determination%20of%20gliclazide%20in%20tablet%20dosage%20form-SCOPUS.pdf |
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eprints |
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iium-603412018-04-18T01:47:48Z http://irep.iium.edu.my/60341/ Development and validation of new RP-HPLC method for the determination of gliclazide in tablet dosage form Alaama, Mohamed Helaluddin, Abul Bashar Mohammed Abbas, Syed Atif QD Chemistry RS Pharmacy and materia medica RS403 Materia Medica-Pharmaceutical Chemistry A new sensitive and economic analytical method for the analysis of gliclazide in tablet dosage form was developed and validated using commercial HPLC instrument with modern ultra-performance liquid chromatography column. Samples were analysed using Agilent 1100 Series RP-HPLC equipped with a binary pump and auto injector. Samples were injected into Xselect HSS C18 XP column (2.1 × 100 mm, 2.5 μm), 2.5 μm) and the mobile phase consisted of triethylamine buffer 0.3% (pH = 3 adjusted using phosphoric acid) and acetonitrile in the ratio of 50:50 v/v. The flow rate was 0.4 mL/min and the DAD de- tector was used for the detection and the wavelength was 229 nm. The method was validated according to ICH guidelines. The retention time for gliclazide peak was 3.437 ± 0.41 min with the total run time of 6 min with total solvent consumption of 2.4 mL per run. The method was found linear over the range 0.1-10 μg/mL with coefficient of determination R2 of 0.9997. The recovery was 98.09-100.19 %, and the method showed high precision and repeatability. Degradation pathway of gliclazide was studied following differ- ent types of stress degradation which are base, acid, UV, and oxidization. All validated parameters were in the acceptable range of ICH requirements. In conclusion, a new, rapid, sensitive, and economic method was developed and validated for the analysis of gliclazide in tablet dosage form. RESUMEN. Se desarrolló un nuevo método analítico sensible y económico para el análisis de gliclazida en forma de dosificación de comprimidos y se validó usando HPLC con una columna moderna de cromatografía líquida de ultra rendimiento. Las muestras se analizaron utilizando un equipo RP-HPLC Agilent Serie 1200 equipado con bomba cuaternaria y autoinyector. Las muestras se inyectaron a una columna de agua C18 HSS (2,1 × 100 mm, 2,5 μm) y la fase móvil consistió en tampón de trietilamina 0,3% (pH = 3 ajustado usando ácido fosfórico) y ace- tonitrilo en la relación 50:50 v/ v. El caudal era de 0,4 mL/ min y se utilizó un detector UV y la longitud de onda fue de 229 nm. El método fue validado de acuerdo con las pautas de ICH. El tiempo de retención para el pico de gliclazida fue de 3,437 ± 0,41 min con el tiempo total de ejecución de 6 min y un consumo total de disolventes de 2,4 mL por ciclo. El método se encontró lineal en el intervalo de 0,1-10 μg/mL con un coeficiente de determi- nación R2 de 0,9997. La recuperación fue de 98,09-100,19%, y el método mostró alta precisión y repetibilidad. La vía de degradación de gliclazida se estudió después de diferentes tipos de degradación del estrés que son base, ácido, UV y oxidación. Todos los parámetros validados estaban dentro del rango aceptable de los requisitos de ICH. En conclusión, se desarrolló y validó un nuevo método rápido y sensible para el análisis de gliclazida en forma de tableta. College of Pharmacists of Buenos Aires Province, Argentina 2017 Article PeerReviewed application/pdf en http://irep.iium.edu.my/60341/1/Latin_American_Journal_of_Pharmacy_36_8_page_1642.pdf application/pdf en http://irep.iium.edu.my/60341/7/60341-Development%20and%20validation%20of%20new%20RP-HPLC%20method%20for%20the%20determination%20of%20gliclazide%20in%20tablet%20dosage%20form-SCOPUS.pdf Alaama, Mohamed and Helaluddin, Abul Bashar Mohammed and Abbas, Syed Atif (2017) Development and validation of new RP-HPLC method for the determination of gliclazide in tablet dosage form. Latin American Journal of Pharmacy, 36 (8). pp. 1642-1647. ISSN 0326-2383 E-ISSN 2362-3853 http://www.latamjpharm.org/previous_issue.php?vol=36&num=8 |
| repository_type |
Digital Repository |
| institution_category |
Local University |
| institution |
International Islamic University Malaysia |
| building |
IIUM Repository |
| collection |
Online Access |
| language |
English English |
| topic |
QD Chemistry RS Pharmacy and materia medica RS403 Materia Medica-Pharmaceutical Chemistry |
| spellingShingle |
QD Chemistry RS Pharmacy and materia medica RS403 Materia Medica-Pharmaceutical Chemistry Alaama, Mohamed Helaluddin, Abul Bashar Mohammed Abbas, Syed Atif Development and validation of new RP-HPLC method for the determination of gliclazide in tablet dosage form |
| description |
A new sensitive and economic analytical method for the analysis of gliclazide in tablet dosage
form was developed and validated using commercial HPLC instrument with modern ultra-performance
liquid chromatography column. Samples were analysed using Agilent 1100 Series RP-HPLC equipped
with a binary pump and auto injector. Samples were injected into Xselect HSS C18 XP column (2.1 × 100
mm, 2.5 μm), 2.5 μm) and the mobile phase consisted of triethylamine buffer 0.3% (pH = 3 adjusted using
phosphoric acid) and acetonitrile in the ratio of 50:50 v/v. The flow rate was 0.4 mL/min and the DAD de-
tector was used for the detection and the wavelength was 229 nm. The method was validated according to
ICH guidelines. The retention time for gliclazide peak was 3.437 ± 0.41 min with the total run time of 6
min with total solvent consumption of 2.4 mL per run. The method was found linear over the range 0.1-10
μg/mL with coefficient of determination R2 of 0.9997. The recovery was 98.09-100.19 %, and the method
showed high precision and repeatability. Degradation pathway of gliclazide was studied following differ-
ent types of stress degradation which are base, acid, UV, and oxidization. All validated parameters were in
the acceptable range of ICH requirements. In conclusion, a new, rapid, sensitive, and economic method
was developed and validated for the analysis of gliclazide in tablet dosage form.
RESUMEN. Se desarrolló un nuevo método analítico sensible y económico para el análisis de gliclazida en forma
de dosificación de comprimidos y se validó usando HPLC con una columna moderna de cromatografía líquida de
ultra rendimiento. Las muestras se analizaron utilizando un equipo RP-HPLC Agilent Serie 1200 equipado con
bomba cuaternaria y autoinyector. Las muestras se inyectaron a una columna de agua C18 HSS (2,1 × 100 mm,
2,5 μm) y la fase móvil consistió en tampón de trietilamina 0,3% (pH = 3 ajustado usando ácido fosfórico) y ace-
tonitrilo en la relación 50:50 v/ v. El caudal era de 0,4 mL/ min y se utilizó un detector UV y la longitud de onda
fue de 229 nm. El método fue validado de acuerdo con las pautas de ICH. El tiempo de retención para el pico de
gliclazida fue de 3,437 ± 0,41 min con el tiempo total de ejecución de 6 min y un consumo total de disolventes
de 2,4 mL por ciclo. El método se encontró lineal en el intervalo de 0,1-10 μg/mL con un coeficiente de determi-
nación R2 de 0,9997. La recuperación fue de 98,09-100,19%, y el método mostró alta precisión y repetibilidad.
La vía de degradación de gliclazida se estudió después de diferentes tipos de degradación del estrés que son base,
ácido, UV y oxidación. Todos los parámetros validados estaban dentro del rango aceptable de los requisitos de
ICH. En conclusión, se desarrolló y validó un nuevo método rápido y sensible para el análisis de gliclazida en
forma de tableta. |
| format |
Article |
| author |
Alaama, Mohamed Helaluddin, Abul Bashar Mohammed Abbas, Syed Atif |
| author_facet |
Alaama, Mohamed Helaluddin, Abul Bashar Mohammed Abbas, Syed Atif |
| author_sort |
Alaama, Mohamed |
| title |
Development and validation of new RP-HPLC method
for the determination of gliclazide in tablet dosage form |
| title_short |
Development and validation of new RP-HPLC method
for the determination of gliclazide in tablet dosage form |
| title_full |
Development and validation of new RP-HPLC method
for the determination of gliclazide in tablet dosage form |
| title_fullStr |
Development and validation of new RP-HPLC method
for the determination of gliclazide in tablet dosage form |
| title_full_unstemmed |
Development and validation of new RP-HPLC method
for the determination of gliclazide in tablet dosage form |
| title_sort |
development and validation of new rp-hplc method
for the determination of gliclazide in tablet dosage form |
| publisher |
College of Pharmacists of Buenos Aires Province, Argentina |
| publishDate |
2017 |
| url |
http://irep.iium.edu.my/60341/ http://irep.iium.edu.my/60341/ http://irep.iium.edu.my/60341/1/Latin_American_Journal_of_Pharmacy_36_8_page_1642.pdf http://irep.iium.edu.my/60341/7/60341-Development%20and%20validation%20of%20new%20RP-HPLC%20method%20for%20the%20determination%20of%20gliclazide%20in%20tablet%20dosage%20form-SCOPUS.pdf |
| first_indexed |
2023-09-18T21:25:32Z |
| last_indexed |
2023-09-18T21:25:32Z |
| _version_ |
1777412166034391040 |