“STUDIES ON QUANITITATIVE EVALUATION OF

β–LACTAM ANTIBIOTIC DRUGS”

SYNOPSIS FOR

M.PHARM DISSERTATION

SUBMITTED TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

4TH ‘ T’ BLOCK, JAYANAGAR, BANGALORE –560 041

BY

G.DHARMA MOORTHY

1 M.PHARM.

DEPARTMENT OF PHARMACEUTICAL ANALYSIS,

BHARATHI COLLEGE OF PHARMACY,

BHARATHI NAGARA

MANDYA (DIST)-571422

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

KARNATAKA.

annexure – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERTATION

1 / Name of the candidate & Address(in block letters) / G.DHARMA MOORTHY
I M.PHARM,.
DEPARTMENT OF PHARMACEUTICAL ANALYSIS,
BHARATHI COLLEGE OF PHARMACY,
BHARATHI NAGARA,
MANDYA(DIST)-571422
PERMANENT ADDRESS:
G.DHARMA MOORTHY
S/O G.MUNIRATHNAIAH
D.NO.11-115
YOGI MALLAVARAM
TIRUCHANUR ROAD
TIRUPATI-517503
2 / Name of the institution / BHARATHI COLLEGE OF PHARMACY,
BHARATHI NAGARA,
MANDYA(DIST)
KARNATAKA-571422.
3 / Course of the study and subject / MASTER OF PHARMACY
(Pharmaceutical Analysis)
4 / Date of admission / 31.5.2007
5 / Title of the topic / “STUDIES ON QUANTITATIVE EVALUATION OF β-LACTAM ANTIBIOTIC DRUGS”
6 / BRIEF RESUME OF THE INTENDED WORK
6.1 NEED FOR THE STUDY
Combination formulation of Ampicillin & cloxacillin sodium is ß-lactam
antibiotic. They are aminopencillin–isoxazylpencillin combination drugs. They are
extensively used in the therapy of penicillin resistant to infections, and also used
for veterinary purposes.
Ampicillin& cloxacillin sodium are official in I.P, B.P, U.S.P.
Structure Of Ampicillin:

Molecular formula: C16H19N3O4SMol. Wt. 349.40
Chemical Name: (6R)-6-(œ-phenyl-d-glycylamino) penicillanic acid.
Analytically useful functional groups : Amino, Carboxylic, Ketone and Unsaturation
groups.
Structure of cloxacillin sodium:

Molecular formula;C19H17ClN3NaO5S,H2OMol.wt.475.88
Chemical name; (6R)-6-(3-(2-chlorophenyl)-5-methylisoxazole-4-carmaxamido)pencillanate monohydrate.
Analytically useful functional groups :Halo, Ketone and Unsaturation groups.
7 / The literature review reveals that the spectrophotometric methods for the analysis
of the drugs are individually carried out on the basis of total penicillin. But there is no spectrophotometric method for the non-separative simultaneous analysis of these ß-lactam antibiotic combination drugs1-4.
Due to similarity of structures of the Ampicillin and
cloxacillin sodium, the U.V-Visible spectra and simple absorption
Spectrophotometry cannot be performed. Hence in the present study the utility of
derivative Spectrophotometry5 will be explored for the specific analysis of
Ampicillin & Cloxacillin sodium combination in synthetic drug mixtures, stability
Samples and in both fresh and aged marketed formulations.
6.2 REVIEW OF LITERATURE
1) Qureshi.S.Z et al1 have reported the simultaneous spectrophotometric and volumetric determination of amoxicillin , ampicillin and cloxacilln in drug
formulations to reaction mechanism is based on the base catalysed hydrolysis
followed by oxidation with iodate in dilute acidic solution.
2) Mohammed .G et al2 have reported the spectrophotometric determination of ampicillin, dicloxacilllin, flucloxacillin and amoxicillin antibiotic drugs based on ion-pair formation with molybdenum and thio cyanate.
3) Straub R. F., et al3 have reported the determination of penicillin-G, ampicillin, amoxicillin and cephapirin by high performance liquid chromatography – electro spray mass spectrometry.
4) Jehl F Birckelp et al 4 have reported the hospital routine analysis of penicillins, third generation cephalosporins and aztreonam by conventional and high-speed high performance liquid chromatography.
5) Ojeda.CB et al5 have reported the recent developments in derivative ultra Violet/ visible Spectrophotometry of antibiotic drugs.
6) Takeba K Fujinuma K. et al6 have reported the Simultaneous determination of β-lactam antibiotics inmilk by ion-pair liquid chromatography.
6.3 OBJECTIVE OF THE STUDY:
1) To establish sensitive and accurate derivative spectroscopic method for the Quantitative estimation of Ampicillin& Cloxacillin Sodium combination drugs in various pharmaceutical fresh and aged marketed products like capsules, injections and syrups etc.
2) These derivative spectroscopic results will be evaluated with chromatographic
methods( HPLC/HPTLC)
3) To validate the obtained results in accordance with the analytical validation parameters mentioned in the I.P and I.C.H guidelines.
MATERIALS AND METHODS
In the present investigation of the β-lactam antibiotic combination drugs (ampicillin and cloxacillin sodium) are analysed by using derivative spectrophotometric method, for this per pose 2201 systronics double beam spectro photometer after (using uv-range is 250-360nm) and coppersulphate solution or phosphate buffer chemicals are used.
These obtaining derivative spectrophotometric results will be evaluated with chromatographic methods [HPLC/HPTLC].
The pure samples of Ampicillin and Cloxacillin sodium will be procured from Medrich pharmaceuticals Bangalore. The combination of ampicillin and cloxacillin sodium will be purchased from standard companies ( Marketed Products) . The methods will be standardized on 2201 systronics double beam spectro photometer and other chromatographic instruments, using calibrated volumetric glass apparatus.
7.1 SOURCE OF DATA
1.Library IISC, Bangalore.
2.Bharathi college of pharmacy library, Bharathi nagara.
3.e-library from Bharathi college of pharmacy library, Bharathi nagara.
4.RGUHS library ,Bangalore.
Data collected from:
Analytical and chemical abstracts , Indian institute of sciences , Bangalore.

Journals

Indian journal of analytical chemistry
American association of pharmaceutical sciences
Journal of chromatography.A
Talanta
Journal of Pharmaceutical biomedical applications.
Indian journal of Pharmaceutical sciences.
Related links




Drug bank
7.2 METHODS OF COLLECTION OF DATA
Considering of similar chemical structures of Ampicillin and cloxacillin sodium, derivative spectrophotometric method will be explored for the specific analysis, for the development of derivative spectrophotometric method copper sulphate solution or phosphate are used. These obtained derivative spectrophotometric results will be evaluated with chromatographic methods are planned.
7.3 Does the study require any investigation or investigations to be conducted on patients or other humans or animals?
-NOT APPLICABLE-

7.4 Has ethical clearance been obtained from your institution in case of 7.3?
-NOT APPLICABLE-
8 / LIST OF REFERENCES
1.Qureshi.S.Z. Qayoom.T and Helalet.M.I. simultaneous spectrophotometric and volumetric determination of amoxicillin , ampicillin and cloxacilln in drug formulations , reaction mechanism is the based on the base catalysed hydrolysis followed by oxidation with iodate in dilute acidic solution. J.pharm. Biomedical.Anal. 1999,21,473-482.
2.Mohammed .G. spectrophotometric determination of ampicillin, dicluxacilllin flucloxacillin and amoxicillin antibiotic drugs; ion-pair formation with molybdenum and thio cyanate .J.pharm.Biomed-anal, 2001,24,561-567
3.Straub R. F and Voyksner R.D. Determination of penicillinG, ampicillin, amoxicillin, and cephapirin by high performance liquid chromatography- electro spray mass spectrometry. J.Chromatography.A 1993, 647-181
  1. Jehl F Birckelp and Monteil .H Hospital routine analysis of penicillins, third generation cephalosporins and aztreonam by conventional and high-speed high performance liquid chromatography. J.chromatography. Biomed. Appl,1987,413. 109-119.
  1. Ojeda.CB Rojas F.S and pavan J.M.C Recent developments in derivative
ultra Violet/ visible Spectrophotometryto antibiotic drugs
Talanta.1995,42/1195-1214
  1. Takeba K Fujinuma K., Miyazaki T. and Nakazawa H. Simultaneous determination of β-lactam antibiotics inmilk by ion-pair liquid chromatography. J.chromatogr.A 1998,812 , 205-211.
7.Dinc.E kokdl.G and onure.F Derivaive ratio spectra zero crossing Spectrophotometry and LC method applied to the quantitative determination of paracetamol , propy phenazole and caffine in ternery mixtures . J.pharm .Biomed .anal 2001,26,769-778
9 / Signature of the candidate / G.Dharmamoorthy
10 / Remarks of the guide / RECOMMENDED
11 / Name and designation of
11.1 Guide / Dr.G.VIJAYA KUMAR
Professor and HOD
Department of Pharmaceutical Analysis,
Bharathi College of Pharmacy,
Bharathi Nagara,
Mandya(Dist)
Karnataka -571422
11.2 signature
11.3 co-guide
11.4 signature / NOT APPILICABLE
11.5 Head of the Department
11.6 signature / Dr.G.VIJAYA KUMAR
Professor and HOD
Department of Pharmaceutical Analysis,
Bharathi College of Pharmacy,
Bharathi Nagara,
Mandya(Dist)
Karnataka -571422
12 / 12.1 Remarks of the chairman and principal:
FORWARDED FOR APPROVAL Dr. T. TAMIZH MANI,
Principal
Bharathi college of pharmacy,
Bharathi Nagara,Mandya(Dist)
Karnataka -571422
12.2signature of the principal: