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Validation of a high-performance liquid chromatographic method for the simultaneous determination of tramadol and its impurities in oral drops as a pharmaceutical formulation

Authorized Users Only
2006
Authors
Zečević, Mira
Stanković, Z
Živanović, L
Jocić, B
Article (Published version)
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Abstract
The novel, rapid high performance liquid chromatographic method for the determination of tramadol hydrochloride and its three impurities was developed and validated. The method can simultaneously assay potassium sorbate, used as preservative. and saccharin sodium, used as sweetener in tramadol pharmaceutical formulation. The separation was carried out on a C-18 XTerra (TM) (150 mm x 4.6 mm, 5 mm) column using acetonitrile-0.015 M Na2HPO4 buffer (2:8, v/v) as mobile phase (pH value 3.0 was adjusted with orthophosphoric acid) at a flow rate 1.0 ml min(-1), temperature of the column 20 degrees C and UV detection at 218 nm. The method was found to be linear (r > 0.999) in the range of 0.05-0.8 mg ml(-1) for tramadol hydrochloride, 0.1-1.2 mg ml(-1) for impurities B and C and for impurity A (r > 0.995) in the range 0.15-2.4 mg ml(-1). The low RSD values indicate good precision and high recovery values indicate excellent accuracy of the HPLC method. Developed method was successfully applied ...to the determination of tramadol hydrochloride. its investigated impurities and potassium sorbate in commercial formulation. The recovery of tramadol hydrochloride was 98.25% and RSD was 1.80%. The method is rapid and sensitive enough to be used to analyse Trodon((R)) oral drops.

Keywords:
column liquid chromatography / reversed phase / tramadol hydrochloride bulk drug and oral drops / potassium sorbate
Source:
Journal of Chromatography A, 2006, 1119, 1-2, 251-256
Publisher:
  • Elsevier Science BV, Amsterdam

DOI: 10.1016/j.chroma.2005.11.105

ISSN: 0021-9673

PubMed: 16386751

WoS: 000238707100035

Scopus: 2-s2.0-33744786235
[ Google Scholar ]
20
11
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/815
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Zečević, Mira
AU  - Stanković, Z
AU  - Živanović, L
AU  - Jocić, B
PY  - 2006
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/815
AB  - The novel, rapid high performance liquid chromatographic method for the determination of tramadol hydrochloride and its three impurities was developed and validated. The method can simultaneously assay potassium sorbate, used as preservative. and saccharin sodium, used as sweetener in tramadol pharmaceutical formulation. The separation was carried out on a C-18 XTerra (TM) (150 mm x 4.6 mm, 5 mm) column using acetonitrile-0.015 M Na2HPO4 buffer (2:8, v/v) as mobile phase (pH value 3.0 was adjusted with orthophosphoric acid) at a flow rate 1.0 ml min(-1), temperature of the column 20 degrees C and UV detection at 218 nm. The method was found to be linear (r > 0.999) in the range of 0.05-0.8 mg ml(-1) for tramadol hydrochloride, 0.1-1.2 mg ml(-1) for impurities B and C and for impurity A (r > 0.995) in the range 0.15-2.4 mg ml(-1). The low RSD values indicate good precision and high recovery values indicate excellent accuracy of the HPLC method. Developed method was successfully applied to the determination of tramadol hydrochloride. its investigated impurities and potassium sorbate in commercial formulation. The recovery of tramadol hydrochloride was 98.25% and RSD was 1.80%. The method is rapid and sensitive enough to be used to analyse Trodon((R)) oral drops.
PB  - Elsevier Science BV, Amsterdam
T2  - Journal of Chromatography A
T1  - Validation of a high-performance liquid chromatographic method for the simultaneous determination of tramadol and its impurities in oral drops as a pharmaceutical formulation
VL  - 1119
IS  - 1-2
SP  - 251
EP  - 256
DO  - 10.1016/j.chroma.2005.11.105
ER  - 
@article{
author = "Zečević, Mira and Stanković, Z and Živanović, L and Jocić, B",
year = "2006",
abstract = "The novel, rapid high performance liquid chromatographic method for the determination of tramadol hydrochloride and its three impurities was developed and validated. The method can simultaneously assay potassium sorbate, used as preservative. and saccharin sodium, used as sweetener in tramadol pharmaceutical formulation. The separation was carried out on a C-18 XTerra (TM) (150 mm x 4.6 mm, 5 mm) column using acetonitrile-0.015 M Na2HPO4 buffer (2:8, v/v) as mobile phase (pH value 3.0 was adjusted with orthophosphoric acid) at a flow rate 1.0 ml min(-1), temperature of the column 20 degrees C and UV detection at 218 nm. The method was found to be linear (r > 0.999) in the range of 0.05-0.8 mg ml(-1) for tramadol hydrochloride, 0.1-1.2 mg ml(-1) for impurities B and C and for impurity A (r > 0.995) in the range 0.15-2.4 mg ml(-1). The low RSD values indicate good precision and high recovery values indicate excellent accuracy of the HPLC method. Developed method was successfully applied to the determination of tramadol hydrochloride. its investigated impurities and potassium sorbate in commercial formulation. The recovery of tramadol hydrochloride was 98.25% and RSD was 1.80%. The method is rapid and sensitive enough to be used to analyse Trodon((R)) oral drops.",
publisher = "Elsevier Science BV, Amsterdam",
journal = "Journal of Chromatography A",
title = "Validation of a high-performance liquid chromatographic method for the simultaneous determination of tramadol and its impurities in oral drops as a pharmaceutical formulation",
volume = "1119",
number = "1-2",
pages = "251-256",
doi = "10.1016/j.chroma.2005.11.105"
}
Zečević, M., Stanković, Z., Živanović, L.,& Jocić, B.. (2006). Validation of a high-performance liquid chromatographic method for the simultaneous determination of tramadol and its impurities in oral drops as a pharmaceutical formulation. in Journal of Chromatography A
Elsevier Science BV, Amsterdam., 1119(1-2), 251-256.
https://doi.org/10.1016/j.chroma.2005.11.105
Zečević M, Stanković Z, Živanović L, Jocić B. Validation of a high-performance liquid chromatographic method for the simultaneous determination of tramadol and its impurities in oral drops as a pharmaceutical formulation. in Journal of Chromatography A. 2006;1119(1-2):251-256.
doi:10.1016/j.chroma.2005.11.105 .
Zečević, Mira, Stanković, Z, Živanović, L, Jocić, B, "Validation of a high-performance liquid chromatographic method for the simultaneous determination of tramadol and its impurities in oral drops as a pharmaceutical formulation" in Journal of Chromatography A, 1119, no. 1-2 (2006):251-256,
https://doi.org/10.1016/j.chroma.2005.11.105 . .

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