Analytical Method Development And Method Validation Of

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Analytical Method Development And Method Validation Of

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ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION OF ARTEMETHER AND LUMEFANTRINE IN POWDER FOR ORAL SUSPENSION DOSAGE FORM BY RP-
HPLC
A Dissertation Submitted to THE TAMILNADU Dr. M.G.R MEDICAL UNIVERSITY
CHENNAI - 600 032. In Partial fulfillment for the award of the degree of
MASTER OF PHARMACY IN
PHARMACEUTICAL ANALYSIS
Submitted By NAME: EZHILVANI. A
Reg.No: 261530204
Under the guidance of Dr. I. CAROLIN NIMILA, M.Pharm., Ph.D.,
Assistant Professor, DEPARTMENT OF PHARMACEUTICAL ANALYSIS.
J.K.K.NATTRAJA COLLEGE OF PHARMACY, KUMARAPALAYAM-638183, TAMILNADU. MAY-2017

EVALUATION CERTIFICATE
This is to certify that the dissertation work entitled “ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION OF ARTEMETHER AND LUMEFANTRINE IN POWDER FOR ORAL SUSPENSION DOSAGE FORM BY RP-HPLC ”, submitted by the student bearing Reg. No: 261530204 to “The Tamil Nadu Dr.M.G.R.Medical University – Chennai” , in partial fulfillment for the award of Degree of Master of Pharmacy in Pharmaceutical Analysis was evaluated by us during the examination held on……………..……….

Internal Examiner

External Examiner

CERTIFICATE
This is to certify that the work embodied in this dissertation “ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION OF ARTEMETHER AND LUMEFANTRINE IN POWDER FOR ORAL SUSPENSION DOSAGE FORM BY RP-HPLC”, submitted to “The Tamil Nadu Dr.M.G.R.Medical University”, Chennai, was carried out by Mrs. A. EZHILVANI [Reg.No: 261530204], for the Partial fulfillment of degree of MASTER OF PHARMACY in PHARMACEUTICAL ANALYSIS under my guidance and supervision during the academic year 2016-2017

Dr. I. CAROLIN NIMILA, M.Pharm., Ph.D., Guide and Assistant Professor.

Dr.V.SEKAR, M.Pharm., Ph.D., Professor and HOD.

Dr. R. SAMBATH KUMAR, M.Pharm., Ph.D., Principal.

.
CERTIFICATE
This is to certify that the work embodied in this dissertation entitled “ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION OF ARTEMETHER AND LUMEFANTRINE IN POWDER FOR ORAL SUSPENSION DOSAGE FORM BY RP-HPLC ”, submitted to “The Tamil Nadu Dr. M.G.R. Medical University- Chennai”, in partial fulfillment to the requirement for the award of Degree of MASTER OF PHARMACY in PHARMACEUTICAL ANALYSIS, is a bonafide work carried out by Mrs. A.EZHILVANI, [Reg.No.261530204] during the academic year 2016-2017, under the guidance and supervision of Dr . I . CA RO LI N NI MI L A, M.Pharm., Ph.D., Assistant Professor of pharmaceutical Analysis, J.K.K. Nattraja College of Pharmacy, Kumarapalayam.

Place: Kumarapalayam Date:

Dr. R. SAMBATHKUMAR, M.Pharm, Ph.D., Professor & Principal, J.K.K.Nattraja College of Pharmacy. Kumarapalayam-638 183, Tamil Nadu.

CERTIFICATE
This is to certify that the work embodied in this dissertation “ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION OF ARTEMETHER AND LUMEFANTRINE IN POWDER FOR ORAL SUSPENSION DOSAGE FORM BY RP-HPLC” submitted in partial fulfillment to “The Tamil Nadu Dr.M.G.R. Medical University, Chennai”, in the requirement for the award of degree of MASTER OF PHARMACY in PHARMACEUTICAL ANALYSIS, is a bonafide work carried out by Mrs. A. EZHILVANI, [Reg. No. 261530204] during the academic year 2016-2017, under my guidance and direct supervision in the department of Pharmaceutical analysis, J.K.K.Nataraja College of Pharmacy, Kumarapalayam.

PLACE: Kumarapalayam DATE :

Dr. I. CAROLIN NIMILA M.Pharm., Ph.D., Assistant Professor, Department of Pharmaceutical Analysis, J.K.K.Nataraja college of Pharmacy, Kumarapalayam - 638183, Tamil Nadu.

DECLARATION
The work presented in this dissertation entitled “ANALYTICAL METHOD DEVELOPMENT AND METHOD VALIDATION OF ARTEMETHER AND LUMEFANTRINE IN POWDER FOR ORAL SUSPENSION DOSAGE FORM BY RP-HPLC” was carried out by me, under the direct supervision of Dr.I.CAROLIN NIMILA, M.Pharm., Ph.D., Assistant Professer of Pharmaceutical Analysis, J.K.K.Nattaraja College of Pharmacy, Kumarapalayam.
I further declare that this work is original and this dissertation has not been submitted previously for the award of any other degree, diploma, associate ship and fellowship or any other similar title. The information furnished in this dissertation is genuine to the best of my knowledge.

PLACE: Kumarapalayam DATE :

A. EZHILVANI, Reg.No:261530204,

ACKNOWLEDGEMENT
Firstly, I am many more thankful to the God for blessing me to have a great strength and courage to complete my dissertation. Behind every success there are lots of efforts, but efforts are fruitful due to hands making the passage smoother. So, I am thankful to all those hands and people who made my work grand success.
I am proud to dedicate my humblest regards and deep sense of gratitude and heartfelt thanks to late Thiru. J.K.K. NATARAJAH CHETTIAR, founder of our college. I wish to express my sincere thanks to our most respectful correspondent Tmt. N. SENDAMARAI and our beloved Managing Director Mr. S. OMM SHARRAVANA, B.Com., LLB., for enabling us to do the project work.
I take this opportunity with pride and immense pleasure expressing my deep sense of gratitude to our respectable and beloved guide Dr. I. CAROLIN NIMILA, M.Pharm., Ph.D., Assistant Professer, Department of Pharmaceutical Analysis J.K.K.Nattaraja College of Pharmacy, whose active guidance, innovative ideas, constant inspiration, untiring efforts help encouragement and continuous supervision has made the presentation of dissertation a grand and glaring success to complete this research work successfully.
I express my heartful thanks to our beloved Dr. R. SAMBATH KUMAR, M.Pharm., Ph.D., Principal, J.K.K. Nattaraja College of Pharmacy, Kumarapalayam. For his indispensable support which enable us to complete this task vast success.
My sincere thanks to Dr.V.SEKAR, M.Pharm.,Ph.D., HOD.Professor, Mr.Balasubramni M.Pharm., for their valuable suggestions.

I would like to extend my thanks, gratitude and most respectful regards to Dr. HARIHARA SUBRAMANIAN, M.Pharm, Ph.D., General Manager, Caplin Point Laboratories limited, Chennai for his encouragement , invaluable assistance, observation, suggestion and cooperation in dealing and bringing out this project work successfully.
I am very thankful to Mr.Saravanan, Mr.Anandraj, Mr.Karuna and Mr.Vigneshwaran all the employees for giving their support, kind cooperation and valuable suggestions to complete this project work.
My glorious acknowledgement to Dr. K.SENGODAN, M.B.B.S., administrative officer for encouraging us in a kind and generous manner to complete this work.
A. EZHILVANI (Reg.No.261530204)

Dedicated to Almighty
My Beloved Parents, Husband, &
My Family Members

API CGLP CGMP CV °c FTIR ICH K LOD LOQ mg mcg mL mg/mL N NLT NMT nm PDA RI RP-HPLC RS RSD RT SD

LIST OF ABBRAVATIONS
Active pharmaceutical Ingredient Current Good Laboratories Practices Current Good Manufactures Practices Co-efficient of Variation Degree centigrade Fourier Transmission Infra Red International Conference on Harmonization of Capacity factor Limit of detection Limit of Quantitation Milligram microgram Milliliter Milligram per milliliter Plate number Not less than Not more than Nanometer Photo Diode Array Refractive Index Reverse phase High Performance Liquid Chromatography Resolution Relative Standard Deviation Retention time Standard Deviation
PharmacyAnalysisMethod DevelopmentMethod ValidationDissertation