It is very nice to visit Lambda facility and thanks to warm welcome provided by all the teams. I can easily say one of the best CRO I ever visited. People here are wonderful and doing great job

Reputed Client of Israel

Awesome hospitality & fantastic office. All the best!

Reputed Client of Japan

Excellent hospitality and cooperation received throughout the audit. People are knowledgeable and extremely transparent. Looking for long time relation

Reputed Client of Asia

Facility is too good to conduct the BABE studies and adherence to protocol and quality assurance in conducting studies are meeting sponsor expectations and requirements.

Reputed Client of India

Facility is good, people r trained well and know the subject on which they r working. All the best.

Reputed Client of USA

Highly innovative and advanced research centre that possess bright future for the development of the country.

Reputed International Government Body

It is one of the best facility in India for BA/BE

Reputed Regulatory Authority

Lambda is a very professional CRO. All the staff here are experienced and very knowledgeable. I'm grateful for their accommodations and hospitality. The future, if we want to carry out BE study, we will ask Lambda help again.

Reputed Client of Europe

It was a really pleasant meeting with the PV department, and I am looking forward to the next visit.

Reputed Client of Europe

Amazing and best CRO I ever seen

Reputed Client of China



Home / Blog

A Highly Sensitive LC-MS/MS Method for the Simultaneous Quantification of Bupropion, Hydroxy Bupropion, Erythro Hydro Bupropion and Threo Hydro Bupropion in Human plasma

08 Jul 2018



Bupropion is a relatively weak inhibitor of the neuronal uptake of norepinephrine and dopamine, and does not inhibit monoamine oxidase or the re-uptake of serotonin. It is indicated for the treatment of major depressive disorder and prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder.

A selective and sensitive method at the LLOQ of about 1.0 ng/mL for Bupropion, 2.0 ng/mL for Hydroxy Bupropion, 0.5 ng/mL for Erythro Hydro Bupropion and 1.5 ng/mL for Threo Hydro Bupropion are required. This was accomplished in the new method developed at our end.

Briefly, the method for the quantification of Bupropion, Hydroxy Bupropion, Erythro Hydro Bupropion and Threo Hydro Bupropion involves solid phase extraction using Bupropion-d9, Hydroxy Bupropion-d6, Erythro Hydro Bupropion-d9 and Threo Hydro Bupropion-d9 as internal standards (ISTD).  Chromatographic separation of the drug and all metabolites were achieved on Poroshell 120 SB C-18 2.7µm 100*4.6 mm column with a mobile phase consisting of 5 mM ammonium formate buffer and methanol, with isocratic time program, and a total run-time of 9 minutes with adequate separation between the metabolites. Detection was carried out in a positive electro-spray ionization mode using MRM transitions of 240.04→184.13, 256.06→238.18, 242.05→168.13, 242.10→168.13, 249.09→185.14, 262.08→244.23, 251.11→169.13, and 251.16→169.14 for Bupropion, Hydroxy Bupropion, Erythro Hydro Bupropion, Threo Hydro Bupropion, Bupropion-d9(ISTD), Hydroxy Bupropion-d6 (ISTD), Erythro Hydro Bupropion-d9 (ISTD) and Threo Hydro Bupropion-d9 (ISTD) respectively.

This new method was validated in terms of linearity, stabilities, carry-over effect, reinjection reproducibility, precision, accuracy and selectivity. The linearity ranges from 1 to 300 ng/mL for Bupropion, 2 to 800 ng/mL for Hydroxy Bupropion, 0.5 to 100 ng/mL for Erythro Hydro Bupropion and 1.5 to 600 ng/mL for Threo Hydro Bupropion; and is found to be stable in plasma under the assay conditions. Moreover, the method exhibited good precision and accuracy with precision better than 7.3% and accuracy greater than 98.5% for Bupropion, 12.9% and 96.9% for Hydroxy Bupropion, 12.2% and 93.3% for Erythro Hydro Bupropion and 7.8% and 97.0% for Threo Hydro Bupropion. Also, there was no significant matrix effect observed in normal human lots and no inter-conversion issues.

This validated method is suitable for the analysis of samples from a single oral dose of 150 mg administration to humans under fasting and fed conditions, and will be applied to the analysis of study samples.

To conclude, a selective, simple, precise, accurate and highly sensitive LC-MS/MS method is now available for simultaneous quantification of Bupropion, Hydroxy Bupropion, Erythro Hydro Bupropion and Threo Hydro Bupropion in human plasma.

Looking for a Globally Proven Research Partner?

Contact Us