Rp-Hplc Method for Estimation of Boswellic Acids from Marketed Formulations

“RP-HPLC METHOD FOR ESTIMATION OF BOSWELLIC ACIDS FROM MARKETED FORMULATIONS”

DISSERTATION PROTOCOL

SUBMITTED TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

BANGALORE, KARNATAKA.

SENJALIYA VIKASKUMAR BALUBHAI

B.PHARM

UNDER THE GUIDANCE OF,

Mrs.NEETHA SHETTY H.

ASSISTANT PROFESSOR,

DEPARTMENT OF QUALITY ASSURANCE

SHREE DEVI COLLEGE OF PHARMACY

MANGALORE-574 142

(2011-2013)

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. / NAME OF THE CANDIDATE
AND ADDRESS (IN BLOCK LETTERS) / SENJALIYA VIKASKUMAR BALUBHAI
B-51,MAHADEVNAGAR SOCI.,
NEAR CHOPATI,
NANA VARACHHA,
SURAT- 395006
GUJARAT.
2. /

NAME OF THE INSTITUTION

/ SHREE DEVI COLLEGE OF PHARMACY,
AIRPORT ROAD, KENJAR VILLAGE, MALAVOOR PANCHAYAT,
MANGALORE-574 142,
KARNATAKA.
3. /

COURSE OF STUDY AND SUBJECT

/ MASTER OF PHARMACY IN
QUALITY ASSURANCE
4. / DATE OF ADMISSION OF COURSE / JULY-2011
5.
6.
6.1
6.2
6.3
7.
7.1
7.2
7.3
7.4
8. /

TITLE OF TOPIC:-

“RP-HPLC METHOD FOR ESTIMATION OF BOSWELLIC ACIDS FROM MARKETED FORMULATIONS”
BRIEF RESUME OF THE INTENDED WORK:
NEED FOR THE STUDY:
Arthritis
Rheumatic diseases are characterized by inflammation(signs are redness and/or heat, swelling, and pain) and loss of function of one or more connecting or supporting structures of the body. They especially affect joints, tendons, ligaments, bones, and muscles. Common symptoms are pain, swelling, and stiffness.[12]
Boswellic acids:Boswelliaserrataextract (BSE) is reported to contain monoterpenes, diterpenes and triterpenes.The anti-inflammatory activity of BSE is attributed to the presence of four-pentacyclictriterpene acids.(viz., β-boswellic acid, 3-acetyl β-boswellic acid, 11-keto β-boswellic acid, 3-acetyl 11-keto β-boswellic acid). 11-KBA and A-11-KBA have more pronounced anti-inflammatory activity. Boswellic acid derivative A-11-KBA, is selective, non-competitive, non-redox and potent inhibitors of 5-lipoxygenase, which is the key enzyme of leukotriene biosynthesis from arachidonic acid. It reduces the activity of human leukocyte elastase(HLE). It was reported that acetyl boswellic acids are effective cytotoxic agents, inhibit human topoisomerases I and IIa activity.[12]
The review of literature showed no evidence of RP-HPLC method for estimation of BA in marketed formulations, hence there is scope for the development of the same.
REVIEW OF LITERATURE :
Chemical structure:
[β-boswellic acid (12)]
Chemical name:
3-acetylketo β-boswellic acid
Empirical formula: C30H48O3
Molecular weight : 456 gm/mol
Shah S,et al., developed method forsimultaneous estimation of boswellic acids from the marketed formulations of boswelliaserrata extract and 11-KBA in human plasma by HPTLC method usingaluminium backed precoated with 0.2mm layers of silica gel 60F254 as Stationary phase andhexan-chloroforrm-methanol 5:5:0.5 (v/v) as mobile phase wasdetected by 260 nm at temperature27±2[1]
Goel A, et al., developed method for Simultaneous determination of 3-acetyl-11-keto-β-boswellic acid in a herbal extract and a nanoparticles formulation by HPTLC method usingAluminium foil plates coated with 200 μm silica gel 60F254 as Stationary phase andToluene-ethyl acetate 7:3 ( v/v ) as mobile phasedetected by 250 nm at temperature 25 ± 2°C, Corelation coefficient was0.9989 ± 0.0002, Rf value0.52 ± 0.02 % and recovery 99.35–100.21%.[2]
Ganzera M, et al., developed a Capillary electrochromatographicmethodfor estimation ofboswellic acids in Boswelliaserrata usingStationary Phase was 100 μm ID fused silica filled with 3 μmhypersil ODS materialand mobile Phase wasAcetonitrile:ammoniumformatesolution9:1( v/v) adjusted to pH 6.5 was detected by 254 nm.[3]
Olga N, et al., developed method for Separation and quantification of terpenoids of BoswelliaserrataRoxb. extract by planar chromatography techniques (TLC and AMD) 11-KBA and 3-A-11-KBA were detected by densitometry at 254 nm. BA and 3-ABA were quantified after derivatization with anisaldehydesulphuric acid reagent at 560 nm.[4]
Karen R, et al.,developed method for Simultaneous estimation ofBoswellic Acids in
brain and plasma byHigh-Performance Liquid Chromatography at a
Calibration range of5 to 1500 ng/mlof KBA and AKBA in plasma and 5 to
1000 ng/ml KBA and AKBA in brain.Concentrationof KBA and AKBA detected in
brainwas found to be 99and 95 ng/g respectively. [5]
Berthold B, et al.,developed method for determination of acetyl-11-keto-α-boswellic acid, a novel pentacyclictriterpenoid, in plasma by HPLC using Stationary Phase fluorinated silica gel60Fdetected by PDA detector in which extraction yield was 82%, Linearity range was 0.98 nmol/l to 196 nmol/l.[6]
Lee Y, et al.,developeda High Speed Countercurrent Chromatographic or Thermospray Mass Spectrometric methodfor the analysis of Bio-active Triterpenoic Acids from BoswelliaCarterh using high resolving power of countercurrent chromatography with a newly developed analytical high speed planet centrifuge system (HSCCC).[7]
Girja R, et al.,developed method for determination of Hydrotropic Solubilization of Boswellic Acids from Boswelliaserrataresin. The solubility of boswellic acids was increased by 2 orders of magnitude in the presence of hydrotropes in aqueous solutions. The effect of hydrotrope concentration on the solubility was investigated in detail along with the kinetics of solubilization. The selectivity toward boswellic acids over other terpene compounds was investigated by molecular modeling using the AMBER94 force field.[8]
Karlina M, et al., developed method for simultaneous determination of Bioavailability of boswellic acidsin vitro/in vivo correlation. Release of four individual boswellic acids from BS extract were studied in vitro using a nonconventional two-phase system simulating conditions in the gastrointestinal tract. Based on these data, the dissolution rate constants of boswellic acids were calculated. In addition, the parameters of pharmacokinetics of ketoacidsin vivo were determined and a correlation between these parameters and the rate of release in vitro were studied.[9]
Volmer D, et al., developed the analytical method for identification, characterization and structural elucidation of Boswelliaserrata using Advancedmass spectrometry techniques. The Specific active anti-inflammatory ingredients in this herb were identified as boswellic acids. In animal studies, these acids showed significant reduction in inflammation.[10]
OBJECTIVES OF THE STUDY:
To develop and validate RP-HPLC method for the estimation of Boswellic acid.
To perform analysis of marketed formulations containing Boswellic acid by RP-HPLC method.
To check the quality of marketed products.
MATERIALS AND METHODS:
Materials
Marketed formulation of Boswellic acid,standard drug,Hexane,chloroform,methanol,
Water,Acetonitrile (HPLC grade)
Source of data:
Data will be obtained from Science Direct, Pubmed.gov and other internet facilities, literature search and related articles from library of Shree Devi College of Pharmacy, Mangalore, Digital Library of RGUHS, Bangalore, etc.
Journals
Asian Journal of Research in Chemistry
International Journal of ChemTech Research
Journal of Young Pharmacists
Indian Journal of Pharmaceutical Science
International Journal of Pharmacy and Pharmaceutical Science
Journal of Pharmacy Research
The Indian Pharmacist
Pharma Times
IDR Drug Compendium
Text Books and Pharmacopoeia

Beckett H and Stenlake J, Practical Pharmaceutical Chemistry. 4th ed.

Delhi: CBS Publisher and Distributors, 1997.

Sethi P, Quantitative Analysis of Drugs in Pharmaceutical Formulation,

3rded. Delhi: CBS Publisher and Distributors.

Sethi P, High Performance Liquid Chromatography, Delhi: CBS Publisher and Distributors.

Higuchi T and Brochman E, Hanseen H, Pharmaceutical Analysis, Delhi: CBS Publisher and Distributors, 2005.
Mendham J, Denney C, Barnes D, KthomasJ and Vogel’s text Book of Quantitative Chemical Analysis, 6thed. Pearson education Pvt Ltd, 2002.
The Indian Pharmacopoeia, Government of India, Ministry of Health and Family Welfare, Published by The Indian Pharmacopoeia commission Ghaziabad, Volume 3, 2007.

Internet Browsing
MethodofCollectionofData (IncludingSampling Procedures, IfAny)
Procurement of drug samples and marketed formulations.
Development of RP-HPLC method for estimation of Boswellic acid
Validation of all developed analytical methods as per ICH guidelines.
Does the study require any investigation or intervention to be conducted on patients or other humans or animals? If so, please mention briefly.
- NOT APPLICABLE -
Has ethical clearance been obtained from your institution in case of 7.3?
- NOT APPLICABLE-
LIST OF REFERENCES:

Shah S, Rathod S, SuhagiaN, Patel A, Parmar K, Shah K and Vaishnavi M.Estimation of boswellic acids from market formulations of Boswelliaserrataextract and 11- ketoboswellic acid in human plasma by HPTLC. JChromatogra B. 2007; 232-8.

Goel A, Goel R, Jain K, Singh M and Singh N.Development and Validation of a stability indicating HPTLC method for analysis of 3-A-11-KBA in herbal extract and nanoparticle.ActaChromatographica. 2008;20: 497-511.

Ganzera M, WalfgangS, Gunther B, Khan A and Hermann S.Capillaryelectrochromatography of boswellic acids in Boswelliaserrata.J Sep Sci. 2003;26:1383-8.

Olga P, Svetlana I, AlexandarS and Valery M.Separation and quantification of terpenoids of Boswelliaserrataby planner chromatography.J Sep Sci.2006; 29(14): 2245-50.
Karen R, Juergen M, Baerbal B, Gunter E, Warten M, Manfred Z and Mona T.Determination of boswellic acid in brain and plasma by HPLC/TMS.Analytical chemistry. 2005;77(20): 6640-5.
Berthold B, Waaltraud Z, Felicitas G and Thomas S.High-performance liquid chromatographic determination of acetyl-11-keto-α-boswellic acid, a novel pentacyclictriterpenoid, in plasma using a fluorinated stationary phase and photodiode array detection,J Chromatogra B. 2005;829:144-8.
Lee Y, Pack T, VoyksherD, Fang C, and Ito Y.Application of High Speed Countercurrent Chromatography/Thermospray Mass Spectrometry for the Analysis of Bio-Active Triterpenoic Acids from BoswelliaCarterh.J liq.Chromatogr Relat Technol.1990;13: 2389-98.

Girija R and Vilas G.HydrotropicSolubilization of Boswellic Acids from BoswelliaserrataResin.Langmuir.2003; 19: 8026-32.
Karlina M, Pozharitskaya N, Kosman M and Ivanova A.Bioavaibility of boswellic acid in vitro/ in vivo co-relation. J pharma Chem. 41:569-72.

VolmerD,Advanced mass spectrometry techniques for identification, characterization and structural elucidation of natural products.Planta Med.74.
SkoogA,West M, Holler F and Crouch R.Fundamentals of Analytical Chemistry.Thomson Asia pvt Ltd. 8th edi; 2004;973-4.
Rang H, Dale M, Ritter J and Moore K. Pharmacology. 5th edition, New York: Churchill Livingstone.2003;270-1, 298-9, 306-13.

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9. / Signature of the candidate / (SenjaliyaVikaskumarBalubhai)
10. / Remarks of the Guide:
“RP-HPLC METHOD FOR ESTIMATION OF BOSWELLIC ACIDS FROM MARKETED FORMULATIONS”to be carried out by Mr.SenjaliyaVikaskumar B. of M.Pharm has been discussed and worked out under my direction and supervision as an official guide. The project work envisaged is of great importance in the field of analytical research. The work can be carried out in Quality Assurance Laboratory of Shree Devi College Of Pharmacy for which facilities are available. Hence the project is viable and is recommended for clearance and approval.
11. / Name & Designation of
(in block letters)
11.1Guide / Mrs. NEETA SHETTY H.
Department of Quality Assurance.
Shree Devi College Of Pharmacy,
Airport Road, Kenjar Village,
MalavoorPanchayat,
Mangalore, 574 142
Karnataka.
11.2 Signature
11.3 Head of the department / Dr. SURESH D.
Department of Quality Assurance.
Shree Devi College Of Pharmacy,
Airport Road, Kenjar Village,
MalavoorPanchayat,
Mangalore, 574 142
Karnataka.
11.4 Signature
12. / 12.1 Remarks of Principal:
The Programme and the Research that is undertaken by Mr. SenjaliyaVikaskumar B. has the potential implication in the field of Quality Assurance. The work can be carried in the Research Laboratories of Quality Assurance Department at Shree Devi College Of Pharmacy. Hence the project is recommended and requested for clearance and approval.
12.2 Signature