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2018年8期
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合成多肽药物中三氟乙酸检测方法研
合成多肽药物中三氟乙酸检测方法研
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摘要
未填写
DOI
rdxz5z1ljl/3392873
作者
张莲莲杜开峰
机构地区
摘 要:三氟乙酸(TFA)是多肽药物的一项重要控制项目,目前报道较多的检测方法是离子色谱法(IC) 与高效液相色谱法(HPLC)。本文分别对 IC 及 HPLC 法进行研究:结果表明 IC 法 TFA 定量限为 2.4ng,推算检出限为 0.8ng,且在 0.12088μg/mL~6.044μg/mL 范围内呈良好的线性关系(r = 0.9999);HPLC 法定量限为 6ng,检出限为 1.5ng,且在 0.3023μg/mL~15.115μg/mL 范围内呈良好的线性关系(r = 0.9998),加标回收率为 99.3%~101.7%,精密度(n=6)为 0.192%~0.200%,RSD5=1.4%。结论:IC 法与 HPLC 法相比,在灵敏度,线性及重复性等方面差异不大,均能满足准确检测相关多肽样品中 TFA 含量要求,但 HPLC 法适用范围更广,且能同时检测多肽药物中醋酸(HAC)及三氟醋酸(TFA)含量,达到简单易行、结果准确、灵敏度高、降低成本、提高效率的研究目的。
出处
《药物与人》
2018年8期
关键词
离子色谱法,高效液相色谱法,多肽,三氟乙酸,含量检测中图分类号文献标识码A
AbstractTrifluoroacetic
acid
(TFA)
is
an
important
control
item
of
polypeptide
drugs.
Ion
chromatography
(IC)
and
high
performance
liquid
chromatography
(HPLC)
are
commonly
used
in
the
detection
of
TFA.
In
this
paper
IC
and
HPLC
methods
are
studied
respectively.The
results
showed
that
the
quantitative
limit
of
TFA
by
IC
method
was
2.4
ng
the
detection
limit
was
0.8
ng
and
the
linear
relationship
was
good
in
the
range
of
0.12088
ug/mL
to
6.044
ug/mL
(r=0.9999)
the
quantitative
limit
of
HPLC
was
6
ng
the
detection
limit
was
1.5
ng
and
the
linear
relationship
was
good
in
the
range
of
0.3023
ug/mL
to
15.115
ug/mL
(r
=
0.9998).
The
recovery
was
99.3%
~
101.7%
the
precision
(n
=
6)
was
0.192%
~
0.200%
RSD5
=
1.4%.CONCLUSION
Compared
with
HPLC
IC
method
has
little
difference
in
sensitivity
linearity
and
repeatability
and
can
meet
the
requirement
of
accurate
determination
of
TFA
content
in
related
polypeptide
samples.
However
HPLC
meth
分类
[医药卫生][药学]
出版日期
2018年08月18日(中国期刊网平台首次上网日期,不代表论文的发表时间)
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李丹;张欣;于泓.
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3
罗永刚,张俊,杜丽娟,赖诚诚,孙同文.
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.法学,2010-06.
5
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6
李旋陈锋.
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.文化科学,2018-12.
7
栾崇林;蒋晓华;金刚;代建国.
多肽检测方法研究进展
.职业技术教育学,2014-05.
8
.
相转移催化合成乙酸乙酯方法
.有机化工,2003-02.
9
杨彦飞.
甲醇羰基合成乙酸产品中丙酸的控制方法
.,2022-07.
10
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来源期刊
药物与人(学术版)
2018年8期
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相关关键词
离子色谱法,高效液相色谱法,多肽,三氟乙酸,含量检测中图分类号文献标识码A
AbstractTrifluoroacetic
acid
(TFA)
is
an
important
control
item
of
polypeptide
drugs.
Ion
chromatography
(IC)
and
high
performance
liquid
chromatography
(HPLC)
are
commonly
used
in
the
detection
of
TFA.
In
this
paper
IC
and
HPLC
methods
are
studied
respectively.The
results
showed
that
the
quantitative
limit
of
TFA
by
IC
method
was
2.4
ng
the
detection
limit
was
0.8
ng
and
the
linear
relationship
was
good
in
the
range
of
0.12088
ug/mL
to
6.044
ug/mL
(r=0.9999)
the
quantitative
limit
of
HPLC
was
6
ng
the
detection
limit
was
1.5
ng
and
the
linear
relationship
was
good
in
the
range
of
0.3023
ug/mL
to
15.115
ug/mL
(r
=
0.9998).
The
recovery
was
99.3%
~
101.7%
the
precision
(n
=
6)
was
0.192%
~
0.200%
RSD5
=
1.4%.CONCLUSION
Compared
with
HPLC
IC
method
has
little
difference
in
sensitivity
linearity
and
repeatability
and
can
meet
the
requirement
of
accurate
determination
of
TFA
content
in
related
polypeptide
samples.
However
HPLC
meth
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