Tags

Type your tag names separated by a space and hit enter

Development and validation of a HPLC method for the determination of buprenorphine hydrochloride, naloxone hydrochloride and noroxymorphone in a tablet formulation.
Talanta. 2009 Feb 15; 77(4):1415-9.T

Abstract

A simple isocratic reversed-phase high-performance liquid chromatographic method (RP-HPLC) was developed for the simultaneous determination of buprenorphine hydrochloride, naloxone hydrochloride dihydrate and its major impurity, noroxymorphone, in pharmaceutical tablets. The chromatographic separation was achieved with 10 mmol L(-1) potassium phosphate buffer adjusted to pH 6.0 with orthophosphoric acid and acetonitrile (17:83, v/v) as mobile phase, a C-18 column, Perfectsil Target ODS3 (150 mm x 4.6mm i.d., 5 microm) kept at 35 degrees C and UV detection at 210 nm. The compounds were eluted isocratically at a flow rate of 1.0 mL min(-1). The average retention times for naloxone, noroxymorphone and buprenorphine were 2.4, 3.8 and 8.1 min, respectively. The method was validated according to the ICH guidelines. The validation characteristics included accuracy, precision, linearity, range, specificity, limit of quantitation and robustness. The calibration curves were linear (r>0.996) over the concentration range 0.22-220 microg mL(-1) for buprenorphine hydrochloride and 0.1-100 microg mL(-1) for naloxone hydrochloride dihydrate and noroxymorphone. The recoveries for all three compounds were above 96%. No spectral or chromatographic interferences from the tablet excipients were found. This method is rapid and simple, does not require any sample preparation and is suitable for routine quality control analyses.

Links

Publisher Full Text

Authors+Show Affiliations

Mostafavi A
Department of Chemistry, Shahid Bahonar University of Kerman, Kerman, Iran.
Abedi G
No affiliation info available
Jamshidi A
No affiliation info available
Afzali D
No affiliation info available
Talebi M
No affiliation info available

MeSH

BuprenorphineCalibrationChemistry, PharmaceuticalChromatography, High Pressure LiquidDosage FormsDrug StabilityHydrogen-Ion ConcentrationModels, ChemicalMorphinansNaloxoneReproducibility of ResultsTabletsTechnology, PharmaceuticalUltraviolet Rays

Pub Type(s)

Journal Article

Language

eng

PubMed ID

19084658

Citation

Mostafavi, Ali, et al. "Development and Validation of a HPLC Method for the Determination of Buprenorphine Hydrochloride, Naloxone Hydrochloride and Noroxymorphone in a Tablet Formulation." Talanta, vol. 77, no. 4, 2009, pp. 1415-9.
Mostafavi A, Abedi G, Jamshidi A, et al. Development and validation of a HPLC method for the determination of buprenorphine hydrochloride, naloxone hydrochloride and noroxymorphone in a tablet formulation. Talanta. 2009;77(4):1415-9.
Mostafavi, A., Abedi, G., Jamshidi, A., Afzali, D., & Talebi, M. (2009). Development and validation of a HPLC method for the determination of buprenorphine hydrochloride, naloxone hydrochloride and noroxymorphone in a tablet formulation. Talanta, 77(4), 1415-9. https://doi.org/10.1016/j.talanta.2008.09.024
Mostafavi A, et al. Development and Validation of a HPLC Method for the Determination of Buprenorphine Hydrochloride, Naloxone Hydrochloride and Noroxymorphone in a Tablet Formulation. Talanta. 2009 Feb 15;77(4):1415-9. PubMed PMID: 19084658.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of a HPLC method for the determination of buprenorphine hydrochloride, naloxone hydrochloride and noroxymorphone in a tablet formulation. AU - Mostafavi,Ali, AU - Abedi,Ghazaleh, AU - Jamshidi,Ahmad, AU - Afzali,Daryoush, AU - Talebi,Mohammad, Y1 - 2008/09/24/ PY - 2008/06/30/received PY - 2008/09/12/revised PY - 2008/09/17/accepted PY - 2008/12/17/entrez PY - 2008/12/17/pubmed PY - 2009/6/12/medline SP - 1415 EP - 9 JF - Talanta JO - Talanta VL - 77 IS - 4 N2 - A simple isocratic reversed-phase high-performance liquid chromatographic method (RP-HPLC) was developed for the simultaneous determination of buprenorphine hydrochloride, naloxone hydrochloride dihydrate and its major impurity, noroxymorphone, in pharmaceutical tablets. The chromatographic separation was achieved with 10 mmol L(-1) potassium phosphate buffer adjusted to pH 6.0 with orthophosphoric acid and acetonitrile (17:83, v/v) as mobile phase, a C-18 column, Perfectsil Target ODS3 (150 mm x 4.6mm i.d., 5 microm) kept at 35 degrees C and UV detection at 210 nm. The compounds were eluted isocratically at a flow rate of 1.0 mL min(-1). The average retention times for naloxone, noroxymorphone and buprenorphine were 2.4, 3.8 and 8.1 min, respectively. The method was validated according to the ICH guidelines. The validation characteristics included accuracy, precision, linearity, range, specificity, limit of quantitation and robustness. The calibration curves were linear (r>0.996) over the concentration range 0.22-220 microg mL(-1) for buprenorphine hydrochloride and 0.1-100 microg mL(-1) for naloxone hydrochloride dihydrate and noroxymorphone. The recoveries for all three compounds were above 96%. No spectral or chromatographic interferences from the tablet excipients were found. This method is rapid and simple, does not require any sample preparation and is suitable for routine quality control analyses. SN - 1873-3573 UR - https://www.unboundmedicine.com/medline/citation/19084658/Development_and_validation_of_a_HPLC_method_for_the_determination_of_buprenorphine_hydrochloride_naloxone_hydrochloride_and_noroxymorphone_in_a_tablet_formulation_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0039-9140(08)00686-3 DB - PRIME DP - Unbound Medicine ER -