AU2021107465A4 - Novel assay methods for PANTOPRAZOLE (EC) pellets - Google Patents
Novel assay methods for PANTOPRAZOLE (EC) pellets Download PDFInfo
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- AU2021107465A4 AU2021107465A4 AU2021107465A AU2021107465A AU2021107465A4 AU 2021107465 A4 AU2021107465 A4 AU 2021107465A4 AU 2021107465 A AU2021107465 A AU 2021107465A AU 2021107465 A AU2021107465 A AU 2021107465A AU 2021107465 A4 AU2021107465 A4 AU 2021107465A4
- Authority
- AU
- Australia
- Prior art keywords
- pantoprazole
- pellets
- make
- assay methods
- novel assay
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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- IQPSEEYGBUAQFF-UHFFFAOYSA-N Pantoprazole Chemical compound COC1=CC=NC(CS(=O)C=2NC3=CC=C(OC(F)F)C=C3N=2)=C1OC IQPSEEYGBUAQFF-UHFFFAOYSA-N 0.000 title claims abstract description 23
- 229960005019 pantoprazole Drugs 0.000 title claims abstract description 19
- 239000008188 pellet Substances 0.000 title claims abstract description 11
- 238000003556 assay Methods 0.000 title claims abstract description 8
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 claims abstract description 21
- 239000000843 powder Substances 0.000 claims abstract description 10
- YNWDKZIIWCEDEE-UHFFFAOYSA-N pantoprazole sodium Chemical compound [Na+].COC1=CC=NC(CS(=O)C=2[N-]C3=CC=C(OC(F)F)C=C3N=2)=C1OC YNWDKZIIWCEDEE-UHFFFAOYSA-N 0.000 claims description 16
- 229960004048 pantoprazole sodium Drugs 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 8
- 238000002360 preparation method Methods 0.000 claims description 8
- 238000002347 injection Methods 0.000 description 9
- 239000007924 injection Substances 0.000 description 9
- 239000012472 biological sample Substances 0.000 description 6
- 239000003814 drug Substances 0.000 description 6
- 238000004108 freeze drying Methods 0.000 description 5
- 239000000654 additive Substances 0.000 description 4
- 230000000996 additive effect Effects 0.000 description 4
- 238000001514 detection method Methods 0.000 description 4
- 229940079593 drug Drugs 0.000 description 4
- 230000001681 protective effect Effects 0.000 description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 4
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 238000004949 mass spectrometry Methods 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 230000003113 alkalizing effect Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000001914 filtration Methods 0.000 description 2
- 238000003756 stirring Methods 0.000 description 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 1
- HBAQYPYDRFILMT-UHFFFAOYSA-N 8-[3-(1-cyclopropylpyrazol-4-yl)-1H-pyrazolo[4,3-d]pyrimidin-5-yl]-3-methyl-3,8-diazabicyclo[3.2.1]octan-2-one Chemical class C1(CC1)N1N=CC(=C1)C1=NNC2=C1N=C(N=C2)N1C2C(N(CC1CC2)C)=O HBAQYPYDRFILMT-UHFFFAOYSA-N 0.000 description 1
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 description 1
- 229930182555 Penicillin Natural products 0.000 description 1
- JGSARLDLIJGVTE-MBNYWOFBSA-N Penicillin G Chemical compound N([C@H]1[C@H]2SC([C@@H](N2C1=O)C(O)=O)(C)C)C(=O)CC1=CC=CC=C1 JGSARLDLIJGVTE-MBNYWOFBSA-N 0.000 description 1
- ZLMJMSJWJFRBEC-UHFFFAOYSA-N Potassium Chemical compound [K] ZLMJMSJWJFRBEC-UHFFFAOYSA-N 0.000 description 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 230000003466 anti-cipated effect Effects 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 238000004587 chromatography analysis Methods 0.000 description 1
- 238000009776 industrial production Methods 0.000 description 1
- 239000002932 luster Substances 0.000 description 1
- 239000011159 matrix material Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 229940049954 penicillin Drugs 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 229910052700 potassium Inorganic materials 0.000 description 1
- 239000011591 potassium Substances 0.000 description 1
- 238000003825 pressing Methods 0.000 description 1
- 238000005173 quadrupole mass spectroscopy Methods 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 239000000523 sample Substances 0.000 description 1
- 230000035945 sensitivity Effects 0.000 description 1
- 238000000926 separation method Methods 0.000 description 1
- 229910052708 sodium Inorganic materials 0.000 description 1
- 239000011734 sodium Substances 0.000 description 1
- 235000011121 sodium hydroxide Nutrition 0.000 description 1
- NASFKTWZWDYFER-UHFFFAOYSA-N sodium;hydrate Chemical compound O.[Na] NASFKTWZWDYFER-UHFFFAOYSA-N 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004885 tandem mass spectrometry Methods 0.000 description 1
- 125000000647 trehalose group Chemical group 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N1/00—Sampling; Preparing specimens for investigation
- G01N1/28—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q
- G01N1/38—Diluting, dispersing or mixing samples
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
- C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
- C07D401/12—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings linked by a chain containing hetero atoms as chain links
-
- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N2430/00—Assays, e.g. immunoassays or enzyme assays, involving synthetic organic compounds as analytes
Landscapes
- Physics & Mathematics (AREA)
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Analytical Chemistry (AREA)
- Biochemistry (AREA)
- General Health & Medical Sciences (AREA)
- General Physics & Mathematics (AREA)
- Immunology (AREA)
- Pathology (AREA)
- Measuring Or Testing Involving Enzymes Or Micro-Organisms (AREA)
Abstract
Novel assay methods for PANTOPRAZOLE (EC) pellets
This invention relates to a Novel assay methods for PANTOPRAZOLE (EC) pellets.
5 Take eq.to 40 mg of Pantoprazole Pellets powder in the 100 ml volumetric flask and
dissolve and make up to the volume with the help of Methanol. Now take 5 ml of
above solution & make up to 50 ml with the M.P.
0
5
20
8
Description
Title of the Invention
Novel assay methods for PANTOPRAZOLE (EC) pellets
Field of the Invention
This invention relates to a Novel assay methods for PANTOPRAZOLE (EC) pellets.
Background of the Invention
CN104257616A Pantoprazole sodium freeze-dried powder injection and preparation
method thereof discloses a pantoprazole sodium freeze-dried powder injection
applied to the industrial production field of pantoprazole sodium preparations. The
pantoprazole sodium freeze-dried powder injection comprises pantoprazole sodium,
a freeze-drying protective additive and an acidifying or alkalizing agent, wherein the
freeze-drying protective additive is trehalose; pantoprazole sodium is selected from
one or more of anhydrous pantoprazole sodium and a pantoprazole sodium hydrate;
and the pantoprazole sodium hydrate is selected from one or more of pantoprazole
sodium monohydrate and pantoprazole sodium dihydrate. A preparation method of
the pantoprazole sodium freeze-dried powder injection comprises the following
steps: weighing pantoprazole sodium and the freeze-drying protective additive
according to the prescription, adding an appropriate amount of injection water to
dissolve pantoprazole sodium and the freeze-drying protective additive, then, adding
active carbon, stirring, filtering and decarbonizing; re-adding an appropriate amount
of injection water, uniformly stirring, regulating a pH value to 9-12 by the acidifying or
alkalizing agent, and re-adding the injection water according to the prescription;
sterilizing and filtering the liquid medicine, and feeding the liquid medicine into a
penicillin bottle; and after freeze-drying, pressing and plugging. The pantoprazole
sodium freeze-dried powder injection is reasonable in prescription, high in stability, good in color and luster and appearance formability; and the preparation method of the pantoprazole sodium freeze-dried powder injection is simple.
CN109298105A Method for quantitatively detecting levo-pantoprazole and dextro
pantoprazole in biological sample by means of ultra-high performance convergence
chromatography-mass spectrometry provides a method for quantitatively detecting
the levo-pantoprazole and the dextro-pantoprazole in a biological sample by means
of ultra-high performance convergence chromatography-massspectrometry.
According to the method, after the biological sample to be detected is subjected to
pretreatment, the liquid to be detected is subjected to the ultra-high performance
convergence chromatography-mass spectrometry detection; according to the peak
area and the standard curve of a chiral drug enantiomer and an internal standard in
a detection spectrum, the concentration of different enantiomers of the chiral drug in
the biological sample to be detected is calculated through an internal standard
method; the invention combines the ultra-high performance convergence
chromatography (UPCC) with a triple quadrupole mass spectrometry (MS/MS) for
quantitative detection of chiral drugs in biological samples for the first time; and the
method provided by the invention is high in sensitivity, can meet the separation of
chiral drugs in biological samples with low sample volume, low content, and complex
matrix, and is short in detection time and low in cost.
None of the cited references above disclose or teach what the present invention
discloses or teaches. The present invention distinguishable over these cited prior art
references.
This invention relates to a Novel assay methods for PANTOPRAZOLE (EC) pellets.
Take eq.to 40 mg of Pantoprazole Pellets powder in the 100 ml volumetric flask and
dissolve and make up to the volume with the help of Methanol. Now take 5 ml of
above solution & make up to 50 ml with the M.P.
The detailed description of various exemplary embodiments of the disclosure is
described herein with reference to the accompanying drawings. It should be noted
that the embodiments are described herein in such details as to clearly communicate
the disclosure. However, the amount of details provided herein is not intended to
limit the anticipated variations of embodiments; on the contrary, the intention is to
cover all modifications, equivalents, and alternatives falling within the scope of the
present disclosure as defined by the appended claims.
It is also to be understood that various arrangements may be devised that, although
not explicitly described or shown herein, embody the principles of the present
disclosure. Moreover, all statements herein reciting principles, aspects, and
embodiments of the present disclosure, as well as specific examples, are intended to
encompass equivalents thereof.
The terminology used herein is for the purpose of describing particular embodiments
only and is not intended to be limiting of example embodiments. As used herein, the
singular forms "a"," "an" and "the" are intended to include the plural forms as well,
unless the context clearly indicates otherwise. It will be further understood that the
terms "comprises," "comprising," "includes" and/or "including," when used herein,
specify the presence of stated features, integers, steps, operations, elements and/or
components, but do not preclude the presence or addition of one or more other
features, integers, steps, operations, elements, components and/or groups thereof.
It should also be noted that in some alternative implementations, the functions/acts
noted may occur out of the order noted in the figures. For example, two figures
shown in succession may, in fact, be executed concurrently or may sometimes be
executed in the reverse order, depending upon the functionality/acts involved.
In addition, the descriptions of "first", "second", "third", and the like in the present
invention are used for the purpose of description only, and are not to be construed
as indicating or implying their relative importance or implicitly indicating the number
of technical features indicated. Thus, features defining "first" and "second" may
include at least one of the features, either explicitly or implicitly.
Unless otherwise defined, all terms (including technical and scientific terms) used
herein have the same meaning as commonly understood by one of ordinary skill in
the art to which example embodiments belong. It will be further understood that
terms, e.g., those defined in commonly used dictionaries, should be interpreted as
having a meaning that is consistent with their meaning in the context of the relevant
art and will not be interpreted in an idealized or overly formal sense unless expressly
so defined herein.
These and other advantages of the present subject matter would be described in
greater detail with reference to the following figures. It should be noted that the
description merely illustrates the principles of the present subject matter. It will thus
be appreciated that those skilled in the art will be able to devise various
arrangements that, although not explicitly described herein, embody the principles of
the present subject matter and are included within its scope.
Mobile phase:
Buffer:
Dissolve 1.215 gm of Potassium dighydrogen Orthophosphate in 450 ml of water.
Adjust pH-7.0 with NaOH or Orthophospharic acid
Mobile phase:
To 450 ml buffer add 350 ml Acetonitrile and 200 ml of Methanol degas &filter
through
0.4 pm membrane.
Chromographic Conditions:
Column: C 1 8 [4.6 x 250 mm; 5p]
Flow rate: 1.0 ml/min
Detector: 280 nm.
R.T.: Pantoprazole Sodium : 4.5: MIN (Approx)
Standard preparation:
Take the std equiv. to 45 mg of Pantoprazole Sodium RS in 100 ml of volumetric
and dissolve and make the volume with methanol. Now take 5 ml of above solution &
make up to 50 ml with the M.P.
Test preparation:
Take eq.to 40 mg of Pantoprazole Pellets powder in the 100 ml volumetric flask and
dissolve and make up to the volume with the help of Methanol. Now take 5 ml of
above solution & make up to 50 ml with the M.P.
Calculation:
Pantoprazole Sodium:
AT x WS x 5 x 100 x 50 x Purity. = % of Assay
AS x 100 x 50 x WT x 5 x
Where
AT = Area of test
AS = Area of standard
WS = Weight of standard
WT = Weight of test
Claims (3)
1. Novel assay methods for PANTOPRAZOLE (EC) pellets.
2. The method as claimed in claim 1, wherein for Standard preparation:Take the std
equiv. to 45 mg of Pantoprazole Sodium RS in 100 ml of volumetric and dissolve
and make the volume with methanol. Now take 5 ml of above solution & make up to
50 ml with the M.P.
3. The method as claimed in claim 1, wherein for Test preparation: Take eq.to 40
mg of Pantoprazole Pellets powder in the 100 ml volumetric flask and dissolve and
make up to the volume with the help of Methanol. Now take 5 ml of above solution
& make up to 50 ml with the M.P.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2021107465A AU2021107465A4 (en) | 2021-08-25 | 2021-08-25 | Novel assay methods for PANTOPRAZOLE (EC) pellets |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AU2021107465A AU2021107465A4 (en) | 2021-08-25 | 2021-08-25 | Novel assay methods for PANTOPRAZOLE (EC) pellets |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AU2021107465A4 true AU2021107465A4 (en) | 2022-01-06 |
Family
ID=78958479
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| AU2021107465A Ceased AU2021107465A4 (en) | 2021-08-25 | 2021-08-25 | Novel assay methods for PANTOPRAZOLE (EC) pellets |
Country Status (1)
| Country | Link |
|---|---|
| AU (1) | AU2021107465A4 (en) |
-
2021
- 2021-08-25 AU AU2021107465A patent/AU2021107465A4/en not_active Ceased
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FGI | Letters patent sealed or granted (innovation patent) | ||
| MK22 | Patent ceased section 143a(d), or expired - non payment of renewal fee or expiry |