STUDIES ON SOME NEW ANALYTICAL METHODS FOR THE ESTIMATION OF PARACETAMOL, ACECLOFENAC SODIUM AND TRAMADOL

IN BULK AND DRUG FORMULATION

SYNOPSIS FOR

M.PHARM DISSERTATION

SUBMITTED TO

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA

4TH ‘T’ BLOCK

JAYA NAGAR,

BANGALORE.

BY

TIPPABATHINA.VENUBABU

I M. PHARM

DEPARTMENT OF PHARMACEUTICAL ANALYSIS

BHARATHI COLLEGE OF PHARMACY

BHARATHI NAGARA

KARNATAKA -571422.

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES

KARNATAKA, BANGALORE.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 / Name of the candidate and address / T.VENUBABU
S\O T.SREENIVASARAO,
H.NO: 9-586,
KANIGIRI,
PRAKASAM (DIST),
ANDHRA PRADESH..
PIN-523230
2 / Name of the institution / BHARATHI COLLEGE OF PHARMACY
BHARATHI NAGARA.
MANDYA(DIST)
KARANATAKA-571422
3 / Course of study and subject / MASTER OF PHARMACY
(PHARMACEUTICAL ANALYSIS)
4 / Date of admission / June 2007
5 / Title / Studies On Some New analytical Methods For The Estimation Of Paracetamol,Aceclofenac Sodium And Tramadol In Bulk And Drug Formulation
6 /

Brief resume of the intended work:

6.1 Need for the study:
Multi-ingredients formulations are useful in the management of various ailments where the intake of large number of dosage is avoided.
Paracetamol (Acetaminophen) is an analgesic and antipyretic drug. Which acts by inhibiting the cyclooxygenase enzyme with it s structure?

Aceclofenac sodium is a nonsteroidal anti-inflammatory and antirhematoid drug.it acts by has been shown to exert effects on many mediators of i inhibits synthesis of the inflammatory cytokines interleukin-1b and tumour necrosis factor,and it production of prostaglandin E2.Aceclofenac is having its structure.

Tramadol is an opioid analgesic acts as a weak agonist at all types opoid receptors with
some selectivity for the .µ -receptors

ANALYTICAL FUNCTIONAL GROUPS:
-  amino group
-  carbonyl group(ketone)
-  carboxylic group
-  methoxy group
-  hydroxyl group.
-  Methyl group.
On the literature survey shows that Paracetamol,Aceclofenac sodium and Tramadol were
analysed by HPLC and Spectrometric methods. But there is no methods were found for
simultaneous estimation of Paracetamol ,aceclofenac sodium & tramadol even though this
multi ingredients formulation/s isin therapeutic use.In the view of the need in the industry for
routine analysis of Paracetamol,Aceclofenac sodium and Tramadol in formulations,an attempts
will be made to develop a simple and accurate instrumental methods for simultaneous estimation
of Paracetamol,Aceclofenac sodium and Tramadol in bulk and drug formulation.
6.2 Review of the literature
1.  M.Y.Momin, et al have developed a RP-HPLC method for determination of Aceclofenac and Paracetamol in Tablet dosage form.
2.  G.Subramanian, et al have developed a RP-HPLC method for estimation of Tizanidine,Diclofenac potassium and Paracetamol in tablets.
3.  Srinivasan KK,et al have developed a method for Simultaneous derivative spectrophotometric estimation of aceclofenac and tramadol with paracetamol in combination solid dosage forms.
4.  Mahaparale PR, et al have developed a method for Simultaneous spectrophotometric estimation of aceclofenac and paracetamol in tablet dosage form.
5.  I singhvi and anju goyal visible spectrophotometric estimation of aceclofenac and indapamide in tablets using folin-ciocalteu reagent
6.  Vaishali.Nagulwar, et al have developed a method for UV spectrophotometric Simultaneous estimation of Valdecoxib and Paracetamol in combined tablet dosage form.
7.  A.S Bhavsar, et al have been developed method for RP-HPLC estimation of Paracetamol and Valdecoxib in combined dosage form.
8.  A.Karthik, et al have developed a method for simultaneous estimation of Paracetamol and Domperidone in tablets by RP-HPLC method.
9.  N.Aditya, et al have been developed a method for Simultaneous spectrophotometric estimation of Valdecoxib and Paracetamol in combined tablet formulations.
10.  M.GandhiMathi, et al have been developed a HPTLC method for Simultaneous estimation of Paracetamol and Valdecoxib in tablet dosage form.
6.3 Objectives of the study
  1. To Establish sensitive and accurate method for the quantitative estimation of Paracetamol, Aceclofenac sodium andTramadol in bulk drug formulation by various chromatographic/spectrophotometric methods.
  2. Validate the newly developed methods in accordance with the analytical validation parameters mentioned in the USP and ICH guidelines.
  3. Newly developed validated analytical method will applied for quantitative estimation of Paracetamol, Aceclofenac sodium and tramadol and bulk drug in the formulations.

7.1 Materials and methods
In the present investigation of newer analytical method development of Paracetamol, Aceclofenac sodium and Tramadol in bulk drug formulation, chemicals and other reagents require will be purchased from standard companies; thiss methods will be standadized on chromatographic instruments using calibrated volumetric glass apparatus.
The pure sample of Paracetamol,Aceclofenac sodium and Tramadol and bulk drug formulation for the research work will be procured from IPCA LABORATORIES PVT.LTD.
7.2 Source of data
1 library of BHARATHI college of pharmacy,
2 .e-library of Bharathi college of pharmacy,
3 Helinet , Internet
4. RGUHS library, Bangalore
5. I Isc library,Bangalore.
7.3 Method of collection of data
For selection and standardization of mobile phases to be used in HPLC, different combination and ratio of solvent will be tried to obtain good optimum resolution. By using Retention Time and Chromatogram of Paracetamol,Aceclofenac sodium&Tramadol a typical analytical parameters such as linearity, range, precision, specificity, accuracy, ruggedness and robustness will be determined.
Simultaneous estimation of Paracetamol,Aceclofenac sodium&Tramadol can be carried out through spectroscopy using equation developed by Cramer’s rule and matrices. The equation will be designed using the absorptivity values of the drugs at the λ max .
7.4. Does the study require any investigation or interventions to be conducted
On patients or other humans or animals?
--NOT APPLICABLE-
7.5 Has ethical clearance been obtained from your institution in case of 7.4?
-NOT APPLICABLE-
8.References:-
  1. M.Y.Momin,P.G.Yeole,M.P.Puranik and .S.J .Wadher has developed a RP-HPLC method for determination of Aceclofenac and Paracetamol in Tablet dosage form.IJPS-Jan-Feb2007;69(1)137-139.
  2. G.Subramanian,P.Musmade,S.Agarwal and N.Udupa has developed a RP-HPLC estimation of Tizanidine,Diclofenac potassium and Paracetamol in tablets.IJPS-Sep-Oct2004;pg 694-696.
  1. Srinivasan KK1, Alex J1, Shirwaikar AA1, Jacob S2, Sunil Kumar MR2, Prabu SL3
    has developed a method for Simultaneous derivative spectrophotometric estimation of aceclofenac and tramadol with paracetamol in combination solid dosage forms. Year : 2007 | Volume : 69 | Issue : 4 | Page : 540-545
  1. Mahaparale PR1, Sangshetti JN1, Kuchekar BS and Dr. D. Y. Patil has developed a method for Simultaneous spectrophotometric estimation of aceclofenac and paracetamol in tablet dosage form. Year : 2007 | Volume : 69 | Issue : 2 | Page : 289-292
  1. I singhvi and anju goyal visible spectrophotometric estimation of aceclofenac and indapamide from tablets using folin-ciocalteu reagent.IJPS-jan-feb 2007;vol no 6;page no 164-165
  1. Vaishali.Nagulwar,Y.R.Dhurvey,Shilpa Deshpande,and Kanchan Upadhye has developed a method for UV spectrophotometric Simultaneous estimation of Valdecoxib and Paracetamol in combined tablet dosage form.IJPS –Sep-Oct 2006;page no:639-640
  1. A.S Bhavsar,G.S Talele ,R.A Fursule and S.J Surana has been developed method for RP-HPLC estimation of Paracetamol and Valdecoxib in combined dosage form. IJPS –Sep-Oct 2006;page no:675-677.
  1. A.Karthik,G.Subramanian,A.Ranjith kumar and N.Udupa has developed a method for simultaneous estimation of Paracetamol and Domperidone in tablets by RP-HPLC method. IJPS-Jan-Feb2007;69(1)142-144.
  1. N.Aditya, R.K.Arora,and Meena Tiwari has been developed a method for Simultaneous spectrophotometric estimation of Valdecoxib and Paracetamol in comb tablet formulations IJPS May-June 2006;vol no 68; p.g370-373
  1. M.GandhiMathi,T.K.Ravi,Nilima Shukla and G.Sowmiya HPTLC method for Simultaneous estimation of Paracetamol and Valdecoxib in tablet dosage form. IJPS-jan-feb 2007;vol no 6;page no 145-147.

9. / Signature of the candidate / ( T.VENUBABU)
10. / Remarks of the guide
11. / 11.1 Name and Designation of
Guide / Mr. C. Jose Gnana Babu,
Asst. Professor
Department of Pharmaceutical Analysis
Bharathi College of Pharmacy
Karnataka-571422
11.2Signature
. / 11.3 Co-Guide
11.4 Signature / NOT APPLICABLE
11.5 Head of the department
11.6 Signature:- / Dr. G.VIJAYA KUMAR
Department of pharmaceutical analysis
Bharathi college of pharmacy
Karnataka-571422
12 / Remarks Of The Principal
And Signature / Dr. T. Tamizh Mani,
Principal,
Bharathi College Of Pharmacy,
Bharathi Nagara.