DEVELOPMENT OF NEW ANALYTICAL METHODS FORQUANTITATIVE ESTIMATION OF TRIFLUOPERAZINE HYDROCHLORIDE IN BULK DRUG AND PHARMACEUTICAL FORMULATIONS
SYNOPSIS FOR
M.PHARM DISSERTATION
SUBMITTED TO
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES
BY
HARESHKUMAR .R. CHAUDHARY
B. PHARM
UNDER THE GUIDANCE OF
Dr B. RAMESH
M.Pharm Ph.D
DEPARTMENT OF PHARMACEUTICAL CHEMISTRY
SAC COLLEGE OF PHARMACY
B.G.NAGARA
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
ANNEXURE-II
PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERATION
1 / Name of the candidate & Address / HARESHKUMAR. R. CHAUDHARYSAC COLLEGE OF PHARMACY
B.G.NAGARA-571448
KARNATAKA
PERMANENT ADDRESS:
82, AYODHYANAGAR SOCIETY,
NR. KAKOSHI PHATAK,
SIDDHPUR
PIN NUMBER-384151
PATAN(DIST)
STATE-GUJRAT
2 / Name of the institute / SAC COLLEGE OF PHARMACY
B.G.NAGARA
KARNATAKA -571448
3 / Course of the study / MASTER OF PHARMACY
(Pharmaceutical chemistry)
4 / Date of admission / 26-05-2008
5 / Title of the topic / DEVELOPMENT OF NEW ANALYTICAL
METHODS FOR QUANTITATIVE ESTIMATION
OF TRIFLUOPERAZINE HYDROCHLORIDE IN
BULK DRUG AND PHARMACEUTICAL
FORMULATIONS
6. / BRIEF RESUME OF THE INTENDED WORK
GENERAL DISCUSSION:
Trifluoperazine is a typical anti-psychotic drug of the phenothiazine group. It has a central anti-adrenergic, anti-dopaminergic, and minimal anti-cholinergic activity.
It mainly act on dopamine recepter.The primary indication of trifluoperazine is schizophrenia.Trifluoperazine HCl is effective for the short-term treatment of generalized non-psychotic anxiety.
STRUCTURAL FORMULA:
.2HCL
NOMENCLATURE: 10-[3-(4-methylpiperazin-1-yl)propyl]-
2-(trifluoromethyl)-10H-phenothiazine
MOLECULAR FORMULA:C21H24F3N3S
MOLECULAR WEIGHT: 407.497 g/mole
DESCRIPTION: white to pale yellow, crystalline powder, is prectically odourless and
has a bitter taste.
SOLUBILITY: freely soluble in water,soluble in alcohol, sparingly soluble in
Chloroform, insoluble in ether and benzene.
ANALYTICAL FUCTIONAL GROUPS: Phenothiazine group
Pipridine ring
Methyl groug
Trifloromethane group
6.1 NEED FOR THE STUDY:
Trifluoperazine hydrochloride is anti psychotic drug. The literature survey reveals that various methods has been reported for estimation of some anti psychotic drug by Spectrophotometric 1-3, RP-HPLC 4-6 RP-HPTLC 7and LC, 8-9. In the view of the need in the industry for routine analysis of trifluoperazine, attempts are being made to develop simple and accurate instrumental methods for quantitative estimation of trifluoperazine. Thus there is need for the development of new, simple, sensitive and accurate analytical method for the quantitative estimation of trifluoperazine as an active pharmaceutical ingredient.
6.2 REVIEW OF LITERATURE:
1. Basavaiah K et al.,have developed Spectrophotometric Analysis of some
Phenothiazine Neuroleptics using Chloramine-T.
2. Saudagar RB et al., have developed Spectrophotometric determination
of chlordiazepoxide and trifluoperazine hydrochloride from combined
dosage form.
3. Sachan A et al., have developed a method for simultaneous Spectrophotometric
estimation of benzhexol hydrochloride and trifluoperazine hydrochloride in
Formulations.
4. Julia Sachseet al., have repoted automated analysis of quetiapine and other
anti psychotic drug in human blood by high performance liquid chromatography with
column-switching and spectrophotometric detection.
5.Tanaka et al.,have developed simple and simultaneous determination of few
phenothiazines on human serum by RP-HPLC.
6. EL-Gindu A et al., have developed and repoted spectrophotometric, thin layer
chromatographic-densitometric and high performance liquid chromatographic
determination of trifluoperazine hydrochloride.
7. Maslanka A et al., have developed Densitometric high performance thin-layer
chromatography identification and quantitative analysis of psychotropic drugs.
8. Hasselstrøm J et al., have developed and repoted Fully automated on-line
quantification of quetiapine in human serum by solid phase extraction and liquid
chromatography.
9. Marumo A et al., have developed and repoted analysis of trifluoperazine in human
body fluids using disk solid-phase extraction and liquid chromatography.
7. / 6.3 OBJECTIVES OF THE STUDY:
- To establish sensitive and accurate method/s for the quantitative estimation of trifluoperazine hydrochloride in pure and dosage form.
- To apply the newly developed, validated analytical methods for quantitative estimation of trifluoperazine hydrochloride in bulk and pharmaceutical dosage forms.
MATERIALS:
- All the chemical and reagents for the development of new analytical method to estimate trifluoperazine hydrochloride will be procured from standard companies.
- The method will be standardized on double beam UV-Visible spectrophotometer and/or other chromatographic technique.
- The pure sample of trifluoperazine hydrochloride for the research work will be procured from Sun Pharma, ahmedabad.
The selectivity and accuracy of spectrophotomeric analysis of samples containing absorbing interferents may be markedly emproved by the technique of difference spectrophotometry. The essential feature of a difference spectrophotometry assay is that the measured value is the difference absorbance (∆A) between two equimolar solutions of the trifluoperazine hydrochloride in different chemical forms which exhibit different spectral characteristics
The simplest and most commonly employed technique for altering the spectral properties of the trifluoperazine hydrochloride is the adjustment of the pH by means of aqueous solution of acid , alkali or buffers. The ultraviolet-visible absorption spectra of many substances containng ionsiable functional groups.e.g. phenol, aromatic carboxylic acids and amines, are dependent on the state of ionization of the functional and consequently on the pH of the solution.
Other New method will be planed based on spectrophotometer and chromatographic instruments.
7.2 SOURCE OF DATA:
- IISC library, Bangalore.
- SAC College of pharmacy library, B.G.NAGARA
- E-library, SAC College of pharmacy.
DATA COLLECTED FROM
JOURNALS:
- Journal of Pharmaceutical Research.
- India Journal of Pharmaceutical Sciences.
- Indian Journal of Pharmaceutical Education and Research.
- Journal of Chromatography.
- Asian Journal of Chemistry.
- Journal of Pharmaceutical and Biomedical Analysis.
DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS OR OTHER HUMANS OR ANIMALS?
NOT APPLICABLLE.
7.5 HAS ETHICAL CLEARENCE BEEN OBTAINED FROM YOUR INSTITUTION IN CASE OF 7.4?
NOT APPLICABLE
8. / REFERANCES:
1. Basavaiah K,Manjunatha Swamy J, and Krishnamurthy.G, Analytical Letters.,
41(13), 2354,(2008).
2. Saudagar RB, Swarnlata Saraf, and Saraf S, Indian J of Pharmaceutical Sci.,
69(1),149, (2007).
3. Sachan A and Trivedi P, Eastern pharmacist., 142, 117, (1999).
4. Julia Sachse, Johannes Köller, Sebastian Härtter and Christoph Hiemke,
J. Chromatogr B., 830(2), 342, (2006 ).
5. Tanaka, Einosuke, Nakamura T, Terada M, Shinozuka T, Hashimoto C, Kurihara
and K Honda, J. of chromatography B, Analyt Technol Biomed Life Sci.,
854(1-2), 116, (2007).
6. EL-Gindu A, EL-Zeany B, Awad T,and Shabana MM, J. of pharm. and
Biomed. analysis.,27, 9, (2002).
7. Maslanka A and Krzek J, J. of AOAC International, 88, 70, (2005).
8. Hasselstrøm J and Linnet K,J. of chromatography. B., 798, 9, (2003).
9. Marumo A, Kumazawa T, LeeXP, Fujimaki K, Kuriki A, Hasegawa C, Sato K,
and Seno H,Suzuki O, J. of AOAC International.,89(4), 966, (2006).
9 / Signature of the candidate / HAREHSKUMAR. R. CHAUDHARY.
10 / Remarks of the guide / The proposed research work is original and designed on rational basis. It would be a good contribution.
11 / Name and Designation of 11.1 Guide
11.2 Signature / Dr.B.RAMESH
M.Pharm, Ph.D
Professor
Department of Pharmaceutical chemistry
S.A.C. college of pharmacy
B.G.Nagara 571448
Karnataka
11.3 Co-Guide
11.4 Signature / NOT APPLICABLE
11.5 Head of the Department
11.6 Signature / Dr.B.RAMESH
M.Pharm, Ph.D
Professor
Department of Pharmaceutical chemistry
S.A.C. college of pharmacy
B.G.Nagara 571448
Karnataka
12 / 12.1 Remarks of the Chairman and Principal
12.2 Signature
1