AU2021101439A4 - A novel hplc method of estimation of aceclofenac from multiparticulate dosage and uses thereof - Google Patents

A novel hplc method of estimation of aceclofenac from multiparticulate dosage and uses thereof Download PDF

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AU2021101439A4
AU2021101439A4 AU2021101439A AU2021101439A AU2021101439A4 AU 2021101439 A4 AU2021101439 A4 AU 2021101439A4 AU 2021101439 A AU2021101439 A AU 2021101439A AU 2021101439 A AU2021101439 A AU 2021101439A AU 2021101439 A4 AU2021101439 A4 AU 2021101439A4
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aceclofenac
estimation
water
solution mixture
chromatograph
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AU2021101439A
Inventor
Esra Tariq Anwer
Sumeet Gupta
Duran Kala
Niladri Maiti
Omji Porwal
Adesh K. Saini
Reena Saini
Vipin Saini
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Saini Adesh K Dr
Anwer Esra Tariq Dr
Maiti Niladri Dr
Porwal Dr Omji Prof
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Saini Adesh K Dr
Saini Vipin Prof
Anwer Esra Tariq Dr
Kala Duran Dr
Maiti Niladri Dr
Porwal Dr Omji Prof
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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/15—Medicinal preparations ; Physical properties thereof, e.g. dissolubility
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/216—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acids having aromatic rings, e.g. benactizyne, clofibrate
    • 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
    • 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
    • G01N1/286—Preparing specimens for investigation including physical details of (bio-)chemical methods covered elsewhere, e.g. G01N33/50, C12Q involving mechanical work, e.g. chopping, disintegrating, compacting, homogenising
    • G01N2001/2866—Grinding or homogeneising
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N2030/022—Column chromatography characterised by the kind of separation mechanism
    • G01N2030/027—Liquid chromatography
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N30/00—Investigating or analysing materials by separation into components using adsorption, absorption or similar phenomena or using ion-exchange, e.g. chromatography or field flow fractionation
    • G01N30/02—Column chromatography
    • G01N30/04—Preparation or injection of sample to be analysed
    • G01N30/06—Preparation
    • G01N30/14—Preparation by elimination of some components
    • G01N2030/146—Preparation by elimination of some components using membranes

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  • Life Sciences & Earth Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Analytical Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Pathology (AREA)
  • Immunology (AREA)
  • General Physics & Mathematics (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
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  • Biophysics (AREA)
  • Medicinal Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Molecular Biology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Treatment Of Liquids With Adsorbents In General (AREA)

Abstract

A NOVEL HPLCMETHOD OF SIMATION OF ACECLOFENAC FROM MUTPARTIULA OAGE AND USESTHEREF A simple, sensitive, accurate, economical and reproducible HPLC method has been developed for estimation of aeclofenac from ntuldparticulate dosage form. An octa decyl silan (ODS) Cit column from shimadzu in gdient mode, with mobile phase HPLC grade acetonitrile and water in the ratios of 50:50 was used. The following method obeyed the Beer's law in the concentration range 5-25 pg /mi. The result of analysis wre validated both for statiskally nd by recovery studies. The statistical analysis of data indicated a high level of accuracy for the proposed method as evidenced by low standard deviation (SD) values.

Description

Field of Invention and use of invention: This invention relates to HPLC method of estimation of aceclofenac from multiparticulate dosage. Liquid chromatography is a separation of great importance to the chemical, pharmaceutical and biotechnological industry. The principle is that a sample of a solution of the substances is injected into a column of an porous material (stationary phase) and a liquid (mobile phase) is pumped through the column. The separation of substances is based on differences in rates of migration through the column arising from different partition of the substances between the stationary phase and mobile phase. Depending on the partition behaviors different types of substances, these will elute at different times from the column outlet. Since there are enormous development of this technique. The new technique became rapidly a powerful separation technique and is today called high performance liquid chromatography (HPLC).
Background of Invention Aceclofenac is a new generation non-steroidal anti-inflammatory drug that is effective in the treatment of painful inflammatory diseases and has been used to treat more than 75 million patients worldwide. It has shown good results as compared to diclofenac, naproxen and piroxicam in patients with osteoarthritis and alkylosing spondylitis. It also provides effective analgesia in other indications, such as dental or gynecological pain, lower back pain, ear, nose and throat indications. Aceclofenac appears to be particularly well tolerated amongst the NSAIDs with a lower incidence of gastrointestinal adverse effects. This good tolerance profile results in a reduced withdrawal rate and hence greater compliance with treatment. Aceclofenac is partially soluble in water and soluble in ethanol. Aceclofenac is completely absorbed from the gastrointestinal tract after oral administration with no presystemic metabolism. It has a shorterplasma half-life of 4 to 4.5 hours following oral administration and thus, in the normal course of therapy requires drug administration every 6-8 hours. Aceclofenac is usually administered in a dose of 100 mg given 2-3 times to maintain effective blood concentration throughout the day. Chemically acelofenac is 2-(2-(2-(2, 6-dichlorophenylamino) phenyl) acetoxy) acetic acid. It is phenyl acetic acid derivatives.
Summery of invention: Various dosage forms of aceclofenac are available in Indian and international market. A search of literature reveals that a few methods have been reported for the assay of aceclofenac drug. The aim of present research work was to develop simple, validated and economical method for estimation of aceclofenac from multiple unit controlled release tablet. The procedure was also applied successfully for the analysis of the commercial available aceclofenac multiparticulate dosage form tablets purchased from the local market. 1. A method of estimation of aceclofenac from multiparticulate dosage comprising the steps of; a) weighing and powdering a multiple-unit tablets of aceclofenac ;b) transferring to a volumetric flask and making a solution mixture of HPLC grade acetonitrile and water; c) diluting the with acetonitrile and water, so as to obtained concentration of 5 pg /ml to 25 pg /ml of aceclofenac; d) filtering the solution mixture with a filter paper so as to obtain filtered portion; e) injecting the filtered portion into a chromatograph; f) recoding chromatogram from the chromatograph to estimation of aceclofenac. 2. The method as claimed in claim 1, wherein twenty multiple-unit tablets of aceclofenac are weighed accurately and powdered.3. The method as claimed in claim 1, wherein said aceclofenac is transferred to 100 ml volumetric flask. 4. The method as claimed in claim 1, wherein the solution mixture is made of HPLC grade acetonitrile and water in 50:50 ratios. 5. The method as claimed in claim 1, wherein the solution mixture is filtered through whatman filter paper number one. 6. The method as claimed in claim 1, wherein the filtered portion of samples is separately injected into the chromatograph is 10 pl.
Detailed description of Invention: Various steps involved in the aforementioned process are: Twenty multiple-unit tablets were weighed accurately and powdered .Powder equivalent to 100 mg of aceclofenac was transferred to 100 ml volumetric flask and volume was made up with solution mixtures of HPLC grade acetonitrile and water in :50 ratios. The solutions were filtered through whatman filter paper number one.
'2
This solution was further diluted with acetonitrile and water, to give concentration of pg /ml to 25 pg /m of aceclofenac respectively. The solution was again filtered through what man filter paper number one. The filter portion of samples (about 10pI) was separately injected into the chromatograph and the chromatogram was recorded. Results of the analysis of the multiple-unit tablet formulation are shown in table-i. Liquid chromatography is a separation of great importance to the chemical, pharmaceutical and biotechnological industry. The principle is that a sample of a solution of the substances is injected into a column of an porous material (stationary phase) and a liquid (mobile phase) is pumped through the column. The separation of substances is based on differences in rates of migration through the column arising from different partition of the substances between the stationary phase and mobile phase. Depending on the partition behaviors different types of substances, these will elute at different times from the column outlet. Since there are enormous development of this technique. The new technique became rapidly a powerful separation technique and is today called high performance liquid chromatography (HPLC).
Recovery studies To study the accuracy, reproducibility and the precision of the proposed methods, recovery experiments were carried out. The results of recovery studies were found to be adequate and indicate non interference from the excipient used in the formulation. The results of recovery studies are shown in table-I.
Table -1 Result of the analysis of the multiple-unit tablet formulation
% label Label claim Coefficient Standard Formulations claim estimated* of Error (mg/tab) (Mean Variation S.D)
Aceclofenac multiple-unit 100 mg 94.15±0.43 0.978 0.175 tablet
Marketed Zerodol 100mg 96.20±1.012 1.034 0,413 tablet
*Average of three trials
Table -Il Result of the recovery study for spiked concentration of aceclofenac (Added to pre-analyzed tablet powder)
Amount of drug Aceclofe
% in nac drug % label claim Coeffic Stand Formulatio preanaly sample estimated* lent of ard ns zed added (Mean Variati Error tablet (spiked)i S.D.) on powder( n mg mg) Aceclofena 100 mg 20 101.1810.214 0.621 0.087 c multiple unit tablet 100 mg 40 97.15±0.631 0.703 0.780
Marketed 100 mg 20 95.65±0.492 0.688 0.200 Zerodol tablet 100 mg 40 101.23±2.11 1.203 0.861
Best method of working:
The applicability of the proposed method for estimation of aceclofenac multiple-unit controlled release tablet dosage forms was examined. The results of recovery studies performed at three different levels showed high degree of reproducibility and precision of the methods. The standard deviation calculated was low, indicating the suitability of the proposed method for the estimation of aceclofenac from multiple unit controlled release tablet dosage forms. From the new invention, the above new method give reliable ,accurate and economical result and hence, developed validated method can be adopted in routine analysis of aceclofenac drug in marketed multiple-unit controlled release tablet dosage forms.A simple, sensitive, accurate, economical and reproducible HPLC method has been developed for estimation of aceclofenac from multiparticulate dosage form. An octa decyl silane (ODS) Ce column from shimadzu in gradient mode, with mobile phase HPLC grade acetonitrie and water in the ratios of 50:50 was used. The following method obeyed the Beer's law in the concentration range 5-25 pg /mlt. The result of analysis were validated both for statistically and by recovery studies. The statistical analysis of data indicated a high level of accuracy for the proposed method as evidenced by low standard deviation (SD) values.
EDITORIAL NOTE 2021101439
There is 1 page of claims only.

Claims (7)

  1. We Claim: 1. A method of estimation of acecofeno from mutipartlculate dosage comprising the steps of: a) weighing and powdering a muIple-uit tablets of acecofenac; b) transferring to a volumetric fask and making a solution mixture of HPLC grade acetonitrile and water; c) diluting the with acetonitrile and water, so as to obtained concentration of5 pg /mI to pg iml of acecloenac: d) filtering the solution mixture with a filter paper so as to obtain filtered portion: e) Injecting the filtered portion Into a chromatograph; f) recoding chromatogram from the chromatograph to estimation of acecofenac.
  2. 2. The method as claimedIn claim 1, whereintwenty multiple-unit tablets of acelofenac are weighed accurtely and powdered.
  3. 3. The method as claimed In calm 1, wherein said acedofenac is transferred to 100 m volumetric flask.
  4. 4. The method as claimed in cim 1, wherein the solution mixture is made of HPLC grade acetonitile and water in 50:50 ratis.
  5. 5. The method as claimed in claim 1, wherein the solution mixture isfiltered through whatman filter paper number one.
  6. 6. The method asclaimed in cim 1, wherein thefiltered portion of samples Is separately Injected Into the chromatograph is 10 p.
  7. 7. The method as claimed In claim 1, wherein said method is used in preparation of aceciofenac from multipsrtculate dosage.
AU2021101439A 2021-03-20 2021-03-20 A novel hplc method of estimation of aceclofenac from multiparticulate dosage and uses thereof Ceased AU2021101439A4 (en)

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