CN104965031A - Content measuring method for compound ketoprofen and omeprazole sustained-release capsules - Google Patents

Content measuring method for compound ketoprofen and omeprazole sustained-release capsules Download PDF

Info

Publication number
CN104965031A
CN104965031A CN201510341915.3A CN201510341915A CN104965031A CN 104965031 A CN104965031 A CN 104965031A CN 201510341915 A CN201510341915 A CN 201510341915A CN 104965031 A CN104965031 A CN 104965031A
Authority
CN
China
Prior art keywords
ketoprofen
omeprazole
solution
compound
sustained
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.)
Granted
Application number
CN201510341915.3A
Other languages
Chinese (zh)
Other versions
CN104965031B (en
Inventor
石海英
王金虎
丁备战
孙玲
李晓强
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shandong Lanhua Pharmaceutical Co ltd
Shandong Academy of Pharmaceutical Sciences
Original Assignee
Shandong Lanhua Pharmaceutical Co ltd
Shandong Academy of Pharmaceutical Sciences
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Shandong Lanhua Pharmaceutical Co ltd, Shandong Academy of Pharmaceutical Sciences filed Critical Shandong Lanhua Pharmaceutical Co ltd
Priority to CN201510341915.3A priority Critical patent/CN104965031B/en
Publication of CN104965031A publication Critical patent/CN104965031A/en
Application granted granted Critical
Publication of CN104965031B publication Critical patent/CN104965031B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Abstract

The invention discloses a content measuring method for compound ketoprofen and omeprazole sustained-release capsules. The content measuring method also can be used for detecting other solution containing ketoprofen and omeprazole such as releasing rate solution of the compound ketoprofen and omeprazole sustained-release capsules. Octadecylsilane chemically bonded silica is used as a filler of a chromatographic column; a mixed solvent of acetonitrile and 0.02 mol/l potassium dihydrogen phosphate [with a pH (potential of hydrogen) value which is adjusted by phosphoric acid solution until the pH value reaches 4.0] is used as mobile phase, and the volume ratio of the acetonitrile to the 0.02 mol/l potassium dihydrogen phosphate is 45:55; detecting wavelengths are 210-240 nanometers and 275-285 nanometers. The content measuring method particularly includes respectively preparing reference solution of ketoprofen and reference solution of the omeprazole; preparing test solution of the compound ketoprofen and omeprazole sustained-release capsules; precisely measuring 10-20 micro-liters of the test solution and 10-20 micro-liters of the reference solution, injecting the measured test solution and the measured reference solution in a liquid chromatograph, and recording chromatogram maps; respectively computing the contents of the ketoprofen and the omeprazole in samples by the aid of peak areas according to an external standard process.

Description

The content assaying method of compound Ketoprofen omeprazole sustained-release capsule
Technical field
The invention belongs to Pharmaceutical Analysis detection field, be specifically related to a kind of content of compound Ketoprofen omeprazole sustained-release capsule and the assay method of release inspection.
Background technology
The first compound preparation that compound Ketoprofen omeprazole sustained-release capsule is made up of Ketoprofen and Omeprazole; developed by Meda drugmaker of Sweden; commodity are called Axorid; when the pain of the diseases such as relief from osteoarthritis, rheumatic arthritis and ankylosing spondylitis; can effectively prevent and treat its bad reaction again; effective preventing gastric ulcer and hemorrhage, duplicate protection patient vitals is healthy.Method not about Ketoprofen in Simultaneously test solution and Omeprazole two kinds of content of active component in prior art is open.The detection method of content of compound Ketoprofen omeprazole sustained-release capsule of the present invention, uses a kind of mobile phase condition can determine the content of two kinds of components in this compound preparation simultaneously; The advantage of this detection method is: easy and simple to handle; Measurement result accurately and reliably; Specificity is strong; Detection time is shorter.
Summary of the invention
The object of this invention is to provide a kind of can detect compound Ketoprofen omeprazole sustained-release capsule easily and fast content and release solution in the HPLC assay method of burst size.
For achieving the above object, the following technical scheme that the present invention adopts realizes.
A detection method of content for compound Ketoprofen omeprazole sustained-release capsule, is characterized in that:
(1) chromatographic condition:
Stationary liquid: select octadecylsilane chemically bonded silica to be the chromatographic column of filler;
Mobile phase: be that the mixed solvent that forms of the component A of 35:65 ~ 55:45 and B component is as mobile phase with volume ratio; Described component A is acetonitrile, and B component is concentration is 0.01 ~ 0.05mol/L potassium dihydrogen phosphate, sodium dihydrogen phosphate or ammonium dihydrogen phosphate, with phosphoric acid solution adjust ph to 2.5 ~ 4.5;
Preferred: volume ratio be the acetonitrile-0.02mol/l potassium dihydrogen phosphate mixed solvent of 45:55 as mobile phase, by phosphoric acid solution adjust ph to 4.0;
Determined wavelength: 210 ~ 240nm and 275 ~ 285nm; Preferred 279nm;
Column temperature: 25 ~ 35 DEG C; Preferably 30 DEG C;
Flow velocity: flow velocity 0.8 ~ 1.2ml/min; Preferred 1.0ml/min.
(2) experiment material
A. the preparation of reference substance solution: precision takes Ketoprofen reference substance and is about 200mg, inserts the brown measuring bottle of 100ml, adds 50% acetonitrile solution and dissolves and be diluted to scale, shake up, as Ketoprofen stock solution; Precision takes Omeprazole reference substance and is about 20mg, and add ethanol 20ml and phosphate buffer (pH11.0) about 60ml, jolting makes dissolving, is diluted to scale, shakes up, as Omeprazole stock solution with phosphate buffer (pH11.0).Precision measures Ketoprofen stock solution 10,15,20ml and Omeprazole stock solution 10ml respectively, inserts 100ml measuring bottle, is diluted with water to scale, respectively as the reference substance solution of 100mg/20mg, 150mg/20mg and 200mg/20mg specification.
B. the preparation of need testing solution: get compound Ketoprofen omeprazole sustained-release capsule 10, get content and insert 500ml measuring bottle, add phosphate buffer (pH11.0) 50ml, 1mol/L sodium hydroxide solution 10ml and ethanol 100ml, jolting makes piller dissolve, add phosphate buffer (pH11.0) and be diluted to scale, shake up, centrifugal treating, precision measures supernatant 5ml and inserts 100ml measuring bottle, be diluted with water to scale, shake up and get final product.
C. the preparation of phosphate buffer (pH11.0): get 0.25mol/L sodium radio-phosphate,P-32 solution 110ml and 0.5mol/L disodium phosphate soln 220ml, be diluted with water to 1000ml, shake up and get final product.
(3) precision draws reference substance solution and each 10 ~ 20 μ l of need testing solution, preferably 10 μ l respectively, injection liquid chromatography, measures, calculates the content of Ketoprofen and Omeprazole.
Advantage of the present invention is the high performance liquid chromatography by optimizing, and measure the content of Ketoprofen and Omeprazole in compound Ketoprofen omeprazole sustained-release capsule, the method is easy and simple to handle simultaneously, measurement result accurately and reliably, good stability, reproducible, specificity is strong, and detection time is shorter.
Accompanying drawing explanation
(retention time of Omeprazole and Ketoprofen is respectively 5.1min and 11.8min to the HPLC collection of illustrative plates of Fig. 1 reference substance.)
The HPLC collection of illustrative plates of Fig. 2 negative control solution
Embodiment
Explain content of the present invention by following embodiment, but do not limit the present invention.Because compound Ketoprofen omeprazole sustained-release capsule has 3 specifications, only 100mg/20mg specification is proposed to be described as embodiment.
Instrument and reagent:
Instrument: high performance liquid chromatograph: SHIMADZU LC-20AT SPD-M20A; Chromatographic column: R & C (grinding wound) C 18post (250mm × 4.6mm, 5 μm).
Reference substance: Ketoprofen (Nat'l Pharmaceutical & Biological Products Control Institute 100337-201104); Omeprazole (Nat'l Pharmaceutical & Biological Products Control Institute 100367-201305).
Test sample: compound Ketoprofen omeprazole sustained-release capsule (Pharmaceutical Sciences, Shandong Province).
Reagent: chromatographic grade second eyeball (Dikmapure company), potassium dihydrogen phosphate, sodium dihydrogen phosphate, ammonium dihydrogen phosphate (ADP) (traditional Chinese medicines group), phosphoric acid (analyzing pure).
Solution preparation:
The preparation of reference substance solution: precision takes Ketoprofen reference substance and is about 200mg, inserts the brown measuring bottle of 100ml, adds 50% acetonitrile solution and dissolves and be diluted to scale, shake up, as Ketoprofen stock solution; Precision takes Omeprazole reference substance and is about 20mg, and add ethanol 20ml and phosphate buffer (pH11.0) about 60ml, jolting makes dissolving, is diluted to scale, shakes up, as Omeprazole stock solution with phosphate buffer (pH11.0).Precision measures Ketoprofen stock solution 10ml and Omeprazole stock solution 10ml respectively, inserts 100ml measuring bottle, is diluted with water to scale, shake up, to obtain final product.
The preparation of need testing solution: get compound Ketoprofen omeprazole sustained-release capsule (specification 100mg/20mg) 10, get content and insert 500ml measuring bottle, add phosphate buffer (pH11.0) 50ml, 1mol/L sodium hydroxide solution 10ml and ethanol 100ml, jolting makes piller dissolve, add phosphate buffer (pH11.0) and be diluted to scale, shake up, the centrifugal 15min of 9000r/min, precision measures supernatant 5ml and inserts 100ml measuring bottle, be diluted with water to scale, shake up, to obtain final product.
Be below the chromatographic condition of content assaying method and the screening experiment of solvent of compound Ketoprofen omeprazole sustained-release capsule of the present invention.
1. the selection of mobile phase
With reference to pertinent literature binding tests concrete condition, successively select acetonitrile-phosphate buffer (0.01mol/L sodium dihydrogen phosphate, with phosphoric acid adjust pH 4.0) (55:45, v/v), acetonitrile-phosphate buffer (0.02mol/L ammonium dihydrogen phosphate (ADP), with phosphoric acid adjust pH 3.5) (45:55, v/v), acetonitrile-phosphate buffer (0.03mol/L potassium dihydrogen phosphate, be 3.0 with phosphoric acid adjust pH) (35:65, v/v), acetonitrile-phosphate buffer (0.02mol/L potassium dihydrogen phosphate, with phosphoric acid adjust pH 4.0) (45:55, v/v) be mobile phase, separating effect under each mobile phase condition is in table 1.
Table 1 mobile phase selection result
2. the selection of flow velocity
Select flow velocity to be 0.8, l.0 investigate with 1.2ml/min, difference is less, finally determines that l.0ml/min flow velocity is.
3. the selection of column temperature
Select column temperature to be 25,30 and 35 DEG C to investigate, 35 DEG C are separated variation, finally determine that column temperature is 30 DEG C.
4. the selection of solvent
Successively select acetonitrile, 50% acetonitrile, phosphate buffer (pH11.0), first add phosphate buffer (pH11.0) 50ml, 1mol/L sodium hydroxide solution 10ml and ethanol 100ml, after piller is dissolved, then to add phosphate buffer (pH11.0) to scale be solvent.Solvent selection result is in table 2.
Table 2 solvent selection result
Below for after the chromatographic condition of content assaying method of the present invention determines, verify that it measures the experiment of effect.
1. chromatographic condition
Take octadecylsilane chemically bonded silica as the chromatographic column of filler, with acetonitrile-phosphate buffer (0.02mol/L potassium dihydrogen phosphate, with phosphoric acid adjust pH 4.0) (45:55, v/v) be mobile phase, column temperature 30 DEG C, flow velocity l.0ml/min, determined wavelength 279nm.
2. specificity research
Mixed by each auxiliary material in prescription ratio, take and insert 500ml measuring bottle in right amount, according to need testing solution preparation method preparation, obtain negative controls solution, precision measures 10 μ l injection liquid chromatographies, record chromatogram.The results are shown in accompanying drawing 2, as seen from Figure 2, this product auxiliary material does not affect the chromatographic peak of two major components.
3. linear test and scope
Precision takes Ketoprofen and Omeprazole reference substance is in right amount each, adds dilution and dissolves and dilute and to make in every 1ml about containing Ketoprofen 1000 μ g and Omeprazole 200 μ g solution, as stock solution.It is appropriate that precision measures stock solution, makes every 1ml containing Ketoprofen/Omeprazole 70 μ g/14 μ g, 80 μ g/16 μ g, 90 μ g/18 μ g, 100 μ g/20 μ g, 110 μ g/22 μ g, 120 μ g/24 μ g, 130 μ g/26 μ g as linear solvent; Precision measures each 10 μ l injecting chromatographs of linear solvent, record chromatogram.With peak area A for ordinate, concentration (C) is horizontal ordinate, carries out linear regression, obtains Ketoprofen regression equation: A=1.445 × 10 4c+0.361 × 10 4, linearly dependent coefficient r=0.9997, Omeprazole regression equation: A=1.552 × 10 4c+367.1, linearly dependent coefficient r=0.9993; Wherein Ketoprofen is good linear relation with its peak area within the scope of 69.96 ~ 129.92 μ g/ml, and Omeprazole is good linear relation with its peak area within the scope of 14.06 ~ 26.11 μ g/ml.
4. stability test
Accurate absorption need testing solution 10 μ l, respectively at 0,3,6,9,12h injection liquid chromatography, record peak area, calculate the peak area of Ketoprofen and Omeprazole, RSD is respectively 0.53%, 0.61%, shows that need testing solution is stable in 12h.
5. precision test
Accurate absorption reference substance solution 10 μ l, repeat sample introduction 6 times, record peak area, calculate the peak area of Ketoprofen and Omeprazole, RSD is respectively 0.13%, and 0.21%.
6. replica test
Accurate absorption need testing solution 10 μ l, parallel 6 parts, the content of every part of test sample is measured according to preferred color of choice spectral condition, injection liquid chromatography, record peak area, average every capsules is 99.54% (RSD=0.38%) of labelled amount, 99.43% (RSD=0.43%) respectively containing Ketoprofen and Omeprazole.
7. recovery test
In prescription ratio, precision measures Ketoprofen stock solution and each 3 parts of Omeprazole stock solution 8,10,12ml, adds auxiliary material, inserts 100ml volumetric flask, measures according to above-mentioned preferred color of choice spectral condition, calculates the recovery.The average recovery rate of Ketoprofen and Omeprazole is respectively 98.83% (RSD=0.46%), 99.99% (RSD=0.76%).
8. the assay of compound Ketoprofen omeprazole sustained-release capsule
Get compound Ketoprofen omeprazole sustained-release capsule (lot number FFTA01, FFTA02, FFTA03) 10, get content and insert 500ml measuring bottle, add phosphate buffer (pH11.0) 50ml, 1mol/L sodium hydroxide solution 10ml and ethanol 100ml, jolting makes piller dissolve, add phosphate buffer (pH11.0) and be diluted to scale, shake up, the centrifugal 15min of 9000r/min, precision measures supernatant 5ml and inserts 100ml measuring bottle, be diluted with water to scale, shake up, use high-performance liquid chromatogram determination.
A. be the chromatographic column of filler with octadecylsilane chemically bonded silica, with acetonitrile-phosphate buffer (0.02mol/L potassium dihydrogen phosphate, with phosphoric acid adjust pH 4.0) (45:55, v/v) be mobile phase, column temperature 30 DEG C, flow velocity l.0ml/min, determined wavelength 279nm.
B. respectively accurately draw each 10 μ l of need testing solution under reference substance solution and assay item, injection liquid chromatography, measures, calculates the content of Ketoprofen and Omeprazole, the results are shown in Table 3.
The assay result of Ketoprofen and Omeprazole in table 3 compound Ketoprofen omeprazole sustained-release capsule
The drug release determination of 9 compound Ketoprofen omeprazole sustained-release capsules
Get the release solution during 6h of compound Ketoprofen omeprazole sustained-release capsule (lot number FFTA01, FFTA02, FFTA03), filter, get subsequent filtrate, with high-performance liquid chromatogram determination:
A. be the chromatographic column of filler with octadecylsilane chemically bonded silica, with acetonitrile-phosphate buffer (0.02mol/L potassium dihydrogen phosphate, with phosphoric acid adjust pH 4.0) (45:55, v/v) be mobile phase, column temperature 30 DEG C, flow velocity l.0ml/min, determined wavelength 279nm.
B. respectively accurately draw each 10 μ l of need testing solution under reference substance solution and release item, injection liquid chromatography, measures, calculates the burst size of Ketoprofen and Omeprazole, the results are shown in Table 4.
The 6h drug release determination result of table 4 compound Ketoprofen omeprazole sustained-release capsule

Claims (5)

1. a content assaying method for compound Ketoprofen omeprazole sustained-release capsule, is characterized in that: adopt high performance liquid chromatography (HPLC) to detect, testing conditions is as follows:
Stationary liquid: select octadecylsilane chemically bonded silica to be the chromatographic column of filler;
Mobile phase: be that the mixed solvent that forms of the component A of 35:65 ~ 55:45 and B component is as mobile phase with volume ratio; Described component A is acetonitrile, and B component is concentration is 0.01 ~ 0.05 mol/L potassium dihydrogen phosphate, sodium dihydrogen phosphate or ammonium dihydrogen phosphate, with phosphoric acid solution adjust ph to 2.5 ~ 4.5;
Determined wavelength: 210 ~ 240 nm and 275 ~ 285 nm;
Column temperature: 25 ~ 35 DEG C;
Flow velocity: flow velocity 0.8 ~ 1.2 ml/min;
Experiment material:
A. the preparation of reference substance solution: precision takes Ketoprofen reference substance about 200 mg, inserts the brown measuring bottle of 100 ml, adds 50 % acetonitrile solutions and dissolves and be diluted to scale, shake up, as Ketoprofen stock solution; Precision takes Omeprazole reference substance about 20 mg, and add ethanol 20 ml and phosphate buffer (pH11.0) about 60 ml, jolting makes dissolving, is diluted to scale, shakes up, as Omeprazole stock solution with phosphate buffer (pH11.0); Precision measures Ketoprofen stock solution 10,15 respectively, and 20 ml and Omeprazole stock solution 10 ml, insert 100 ml measuring bottles, be diluted with water to scale, respectively as the reference substance solution of 100 mg/20 mg, 150 mg/20 mg and 200 mg/20 mg specifications;
B. the preparation of need testing solution: get compound Ketoprofen omeprazole sustained-release capsule 10, get content and insert 500 ml measuring bottles, add phosphate buffer (pH11.0) 50 ml, 1 mol/L sodium hydroxide solution 10 ml and ethanol 100 ml, jolting makes piller dissolve, add phosphate buffer (pH11.0) and be diluted to scale, shake up, centrifugal treating, precision measures supernatant 5 ml and inserts 100 ml measuring bottles, be diluted with water to scale, shake up;
C. the preparation of phosphate buffer (pH11.0): get 0.25 mol/L sodium radio-phosphate,P-32 solution 110 ml and 0.5 mol/L disodium phosphate soln 220 ml, be diluted with water to 1000 ml, shake up and get final product;
Accurate absorption reference substance solution and each 10 ~ 20 μ l of need testing solution respectively, injection liquid chromatography, measures, calculates the content of Ketoprofen and Omeprazole.
2. the detection method of content of a kind of compound Ketoprofen omeprazole sustained-release capsule according to claim 1, it is characterized in that: the component A described in HPLC testing conditions is acetonitrile, B component is concentration 0.02 mol/L potassium dihydrogen phosphate, by phosphoric acid solution adjust ph to 4.0, volume ratio is 45:55.
3. the detection method of content of a kind of compound Ketoprofen omeprazole sustained-release capsule according to claim 1, it is characterized in that: the flow velocity described in HPLC testing conditions is 1.0 ml/min, determined wavelength is 279 nm, and column temperature is 30 DEG C.
4. the detection method of content of a kind of compound Ketoprofen omeprazole sustained-release capsule according to claim 1, is characterized in that: the sample size described in HPLC testing conditions is 10 μ l.
5. the detection method of content of a kind of compound Ketoprofen omeprazole sustained-release capsule according to claim 1, it is characterized in that: this method is detecting the content of compound Ketoprofen omeprazole sustained-release capsule, and the application that the release solution of other solution as compound Ketoprofen omeprazole sustained-release capsule simultaneously containing Ketoprofen and Omeprazole detects.
CN201510341915.3A 2015-06-18 2015-06-18 Content measuring method for compound ketoprofen and omeprazole sustained-release capsules Active CN104965031B (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201510341915.3A CN104965031B (en) 2015-06-18 2015-06-18 Content measuring method for compound ketoprofen and omeprazole sustained-release capsules

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201510341915.3A CN104965031B (en) 2015-06-18 2015-06-18 Content measuring method for compound ketoprofen and omeprazole sustained-release capsules

Publications (2)

Publication Number Publication Date
CN104965031A true CN104965031A (en) 2015-10-07
CN104965031B CN104965031B (en) 2017-01-18

Family

ID=54219078

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201510341915.3A Active CN104965031B (en) 2015-06-18 2015-06-18 Content measuring method for compound ketoprofen and omeprazole sustained-release capsules

Country Status (1)

Country Link
CN (1) CN104965031B (en)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108828094A (en) * 2018-06-29 2018-11-16 佛山市南海东方澳龙制药有限公司 Utilize the method and application of Ketoprofen in high performance liquid chromatography-tandem mass method detection blood plasma
CN116165306A (en) * 2023-04-25 2023-05-26 湖南九典制药股份有限公司 Analysis and determination method and application of related substances in ketoprofen gel plaster

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103877085A (en) * 2013-10-16 2014-06-25 山西兰花药业有限公司 Ketoprofen omeprazole sustained-release pellets and preparation method thereof

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103877085A (en) * 2013-10-16 2014-06-25 山西兰花药业有限公司 Ketoprofen omeprazole sustained-release pellets and preparation method thereof

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
VRUSHALI TAMBE,ET AL: "Development and Validation of an HPTLC Method for Simultaneous Estimation of Omeprazole and Ketoprofen in a Developed Tablet Formulation", 《INTERNATIONAL JOURNAL OF PHARMTECH RESEARCH》 *
宫丽等: "复方奥美拉唑胶囊的质量标准", 《解放军药学学报》 *
杨红娟等: "高效液相色谱法测定奥美拉唑肠溶胶囊中奥美拉唑的含量", 《海峡药学》 *
王东青: "HPLC法测定酮洛芬注射液中酮洛芬含量", 《山西农业大学学报(自然科学版)》 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108828094A (en) * 2018-06-29 2018-11-16 佛山市南海东方澳龙制药有限公司 Utilize the method and application of Ketoprofen in high performance liquid chromatography-tandem mass method detection blood plasma
CN116165306A (en) * 2023-04-25 2023-05-26 湖南九典制药股份有限公司 Analysis and determination method and application of related substances in ketoprofen gel plaster
CN116165306B (en) * 2023-04-25 2023-11-17 湖南九典制药股份有限公司 Analysis and determination method and application of related substances in ketoprofen gel plaster

Also Published As

Publication number Publication date
CN104965031B (en) 2017-01-18

Similar Documents

Publication Publication Date Title
CN102798678B (en) Detection method and content determining method of sodium calcium edetate in pantoprazole sodium for injecting
CN103344733A (en) High performance liquid chromatographic separation detection method for bortezomib enantiomers
CN104678031B (en) High performance liquid chromatography detects the method for atractyloside and/or earboxyatractylosida
CN104597171A (en) High performance liquid chromatography analysis method of acarbose and its preparation
CN104965031A (en) Content measuring method for compound ketoprofen and omeprazole sustained-release capsules
CN106124684A (en) A kind of qualitative and quantitative detection method of Pericarpium Granati ZHIXIE SAN
Redasani et al. Stability indicating RP-HPLC method for simultaneous estimation of rupatadine fumarate and montelukast sodium in bulk and tablet dosage form
Rambla-Alegre et al. Analysis of omeprazole and its main metabolites by liquid chromatography using hybrid micellar mobile phases
CN104950047A (en) Method for detecting content, dissolution rate and releasing rate of memantine hydrochloride or analogues thereof in medicinal agent
Patel et al. Simultaneous estimation of pantoprazole and domperidone in pure powder and a pharmaceutical formulation by high-perfomance liquid chromatography and high-performance thin-layer chromatography methods
CN103543222A (en) Reduning injection saccharide content detection method
CN108398497B (en) High performance liquid chromatography detection method of tris (nonylphenol) phosphite ester
CN108169362B (en) Method for separating carbamazepine and related substances by liquid chromatography
CN103163228A (en) Efficient liquid phase analysis method for hydroxyfasudil and preparation thereof
CN102636582B (en) Method for determining content of diminazene and antipyrine in diminazene particle
CN102579961B (en) Detection method for aristolochic acid A in swelling-reducing and pain-alleviating tincture
Bhandage et al. Extractive spectrophotometric determination of omeprazole in pharmaceutical preparations
CN104374861B (en) The method of the related substance of the western croak bulk drug of a kind of HPLC separation determination Leo
CN103063765A (en) Detecting method for ligustrazine hydrochloride in salvia miltiorrhiza and ligustrazine glucose injection
CN108872406A (en) HPLC analyzing detecting method in relation to substance in a kind of L-aminobutanedioic acid bulk pharmaceutical chemicals
CN104181240B (en) A kind of method measuring ethyl hydroxy benzoate content in soft capsule material
Dighe et al. Method development and validation of Rupatadine fumarate and Montelukast sodium by RP-HPLC
Agrawal et al. Method development and validation for the simultaneous determination of Azelnidipine and Telmisartan in tablet dosage form by RP-HPLC
CN102109501B (en) Method for detecting related substances in quinapril hydrochloride and hydrochlorothiazide composition
CN114660213B (en) Component content determination method of compound reserpine hydrochlorothiazide tablet

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C14 Grant of patent or utility model
GR01 Patent grant