Validation of a high-performance liquid chromatographic method for the simultaneous determination of tramadol and its impurities in oral drops as a pharmaceutical formulation
Само за регистроване кориснике
2006
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
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.
Кључне речи:
column liquid chromatography / reversed phase / tramadol hydrochloride bulk drug and oral drops / potassium sorbateИзвор:
Journal of Chromatography A, 2006, 1119, 1-2, 251-256Издавач:
- Elsevier Science BV, Amsterdam
DOI: 10.1016/j.chroma.2005.11.105
ISSN: 0021-9673
PubMed: 16386751
WoS: 000238707100035
Scopus: 2-s2.0-33744786235
Институција/група
PharmacyTY - 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 . .