Synthesis and Anticonvulsant Activity Of

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL AND ETORICOXIB IN PHARMACEUTICAL DOSAGE FORM

M. Pharm Dissertation Protocol Submitted to

Rajiv Gandhi University of Health Sciences, Karnataka Bangalore – 560041

By Mr. PATEL KELVINKUMAR A, B.Pharm Department of Quality Assurance

Under the Guidance of Dr. CHANDRASHEKHAR NARAJJI, M.Pharma, Ph.D Asst. Professor Department of Quality Assurance

Department of Quality Assurance, Acharya & B.M. Reddy College of Pharmacy, Soladevanahalli, Chikkabanavara Post, Bangalore -90.

2009-2011

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, 1 KARNATAKA, BANGALORE.

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

PATEL KELVINKUMAR ARVINDBHAI 1 Name of the Candidate and Address S/O Patel Arvindbhai Govindbhai, ‘Vrundavan’ vijaynagar, Near narsang temple, Ravapar road, Morbi – 363641 Gujarat. 2 Name of the Institution ACHARYA & B.M REDDY COLLEGE OF PHARMACY, Soldevanahalli, Bangalore. Pin-560090. M. PHARM 3 Course of Study and Subject QUALITY ASSURANCE

4 Date of the Admission 04/05/2009

5 Title of the Topic:

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PARACETAMOL AND ETORICOXIB IN PHARMACEUTICAL DOSAGE FORM

2 6.0 BRIEF RESUME OF THE INTENDED WORK: 6.1 NEED FOR THE STUDY

Extensive literature survey reveals that several analytical spectrophotometric methods have been reported for the estimation of paracetamol and for etoricoxib. Development of simple method for the estimation of such drug combinations in single dosage forms is inevitable and challenging. One such drug combination of paracetamol and etoricoxib in tablet form is used for analgesic, antipyretic and COX-2 selective inhibitor.1

The present study is to make an attempt to establish sensitive and accurate methods for the estimation of paracetamol and etoricoxib in pure and tablet dosage form. The proposed to be validated as per ICH guidelines. Based on the objective the plane of the work as follows:

1. Development of new analytical methods 2. Assay of paracetamol and etoricoxib tablet 3. Accuracy studies 4. Precision studies 5. Stability studies 6. Recovery studies 7. Ruggedness and robustness 8. Statistical evaluation 9. Limit of detection and limit of quantization

6.2 GENERAL DISCUSSION:-

PARACETAMOL1,2,3 Paracetamol is an analgesic, antipyretic derivative of acetanilide. It has weak 3 anti-inflammatory properties and is used as a common analgesic.4 Paracetamol is official in all pharmacopoeias and assay is carried out by aqueous titration or spectrophotometry.3 9.0. SIGNATURE OF THE CANDIDATE

10. REMARKS OF THE GUIDE 0 11. NAME AND DESIGNATION OF: 0 11.1 GUIDE Dr. CHANDRASHEKHAR NARAJJI, Asst. Professor, Department of Quality Assurance, Acharya & B.M. Reddy College of Pharmacy, Soldevanahalli, Bangalore-90.

11.2 SIGNATURE

11.3 CO-GUIDE NIL

11.4 SIGNATURE NIL

11.5 HEAD OF THE Mr. A. Cendilkumar, DEPARTMENT Asst. Professor, Department of Quality Assurance, Acharya & B.M. Reddy College of Pharmacy, Soldevanahalli, Bangalore-90.

11.6 SIGNATURE

12. 12.1 REMARKS OF THE 0 PRINCIPAL

12.2 NAME OF THE PRINCIPAL Dr. Divakar Goli, Principal, Acharya & B.M. Reddy College of Pharmacy, Soldevanahalli, Bangalore-90.

12.3 SIGNATURE