Research & Reviews:

A Journal of Drug Formulation,

Development & Production

RRJoDFDP Jan - April 2014

STM JOURNALSScientific Technical Medical

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Research & Reviews: A Journal of Drug Formulation, Development and

Production

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Drug Development

Novel drug delivery systems

International Drug regulatory Affair

Pharmacodynamics & pharmacokinetics

Medicinal Chemistry

Topical Formulations

Galenic formulations

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Chemistry Division CSIR-CDRI,

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Dr. Bhavin P. Marolia

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Analysis, Maliba Pharmacy College

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Dr. Chiau Long

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eknologi MARA, Puncak Alam, Selangor,

Malaysia.

Dr. Bharat Bhusan Subudhi

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Siksha O Anusandhan University,

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Dr. Atla Srinivasa Rao

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Analysis & QA Shri Vishnu College

of Pharmacy , A.P., India.

Mrs. Divya Suares

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University, India.

Dr. George D Geromichalos

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Design, Symeonidion

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Dr. Kashmira Gohil

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Pharmacy College (SDPC), Surat,

Gujarat, India.

Dr. Koteshwara K.B

Professor, Department of Pharmaceutics,

Manipal College of Pharmaceutical Sciences,

Manipal University,India.

Editorial Board

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Pharmaceutics Manipal College of

Pharmaceutical

Sciences, Manipal, India.

Dr. Mohamed Salama

Professor,Faculty of Pharmacy,

UiTM , Malaysia.

Dr. Poonam Singh

Scientist CSIR-Central Drug Research

Institute, Lucknow.

Dr. Pranav Shah

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Dr. Neeraj Kumar Fuloria

Faculty of Pharmacy, AIMST University,

Malysia, Malaysia.

Dr. Mohd Shihabuddin B. A. Noorden

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Universiti Teknologi MARA, 42300

Puncak Alam, Selangor, Malaysia.

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Dr. Rabi Bhatta

Scientist Lab no: PCN-108 Pharmacokinetic

and Metabolism Division CSIR-Central Drug

Research Institute, Lucknow, India.

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CSIR-Indian Institute of Integrative

Medicine,

Jammu, India.

Prof. Dr. Sapna Shrikumar

Principal, Moulana College of Pharmacy,

Angadtppuram (P.O),

Perinthalmanna, Malappuram, Kerala,

India.

Editorial Board

Dr. Shashank K Singh

Senior Scientist,CSIR-Indian institute of

Integrative Medicine ,Canal Road

Jammu, India.

Mr. Soh Yee Chang

Faculty of Pharmacy

UiTM Puncak Alam Campus

Malaysia.

Dr. V. Ravichandran

Faculty of Pharmacy,AIMST University,

Semeling - 08100,Kedah, Malaysia.

Mr. Viral Dineshchandra Jagiwala

Assistant Professor,SHREE Dhanvantary

Pharmacy College, Surat, Gujarat, India.

Dr. Suneel .I.Majagi

Associate Professor Department of

Pharmacology J.N.Medical College

Belgaum-590010.

Karnataka.

Dr. Sridevi Chigurupati

Senior Lecturer Faculty of Pharmacy,

AIMST University, Malaysia.

Dr. Vivek Bhosale

Scientist, Division of Clinical and

Experimental Medicine CSIR-Central

Drug Research Institute, Lucknow, India.

Dr. Waseem Rizvi

Associate Professor

Department of Pharmacology, J. N. Medical

College, A. M. U, Aligarh, India.

J.N. Medical College

A.M.U, Aligarh, India.

Dr. Yahaya Bin Hassan

Head, Faculty of Pharmacy, Universiti

Teknologi MARA(UiTM) , Selangor ,

Malaysia.

I take the privilege to present the print version for the Volume 1 Issue (1) of Journal of Drug

Formulation, Development and Production. The intension of JoDFDP is to create an atmosphere that

stimulates creativeness, research and growth in the area of Drug Formulation, Development and

Production.

The development and growth of the mankind is the consequence of brilliant Research done by

eminent Scientists and Engineers in every field. JoDFDP provides an outlet for Research findings

and reviews in areas of Drug Formulation, Development and Production found to be relevant for

National and International recent developments & research initiative.

The aim and scope of the Journal is to provide an academic medium and an important reference for

the advancement and dissemination of Research results that support high level learning, teaching and

research in the domain of Drug Formulation, Development and Production .

Finally, I express my sincere gratitude and thanks to our Editorial/ Reviewer board and Authors for

their continued support and invaluable contributions and suggestions in the form of authoring write

ups/ reviewing and providing constructive comments for the advancement of the journals. With

regards to their due continuous support and co-operation, we have been able to publish quality

Research/Reviews findings for our customers base.

I hope you will enjoy reading this issue and we welcome your feedback on any aspect of the Journal.

Dr. Archana Mehrotra

Director

STM Journals

Director's Desk

STM JOURNALS

1. Development and Validation of a Gradient RP-HPLC Method for Quantitative Determination of Potential

Manufacturing Impurities in New Drug Apronalide and Pharmaceutical Formulations

Ritesh Mishra, Hitesh Malvia, M. Asif Khan 1

2. In-house Preparation and Quality Control of a Unani Formulation

Mohd. Tariq, Shahid Shah Chaudhary, Ubaidul Hai, Abdullah Tauheed, Peerzada Mohd Younis,

Syeda Anjum Farah 11

3. Isolation, Identification and Molecular Cloning of Chitinase Gene in Bacteria Isolated from

Crustacean Wastes

J.Senthil Kumar, Swathy Variar, K.S. Rishad 17

ContentsResearch & Reviews: A Journal of Drug Formulation, Development and Production

RRJoDFDP (2014) STM Journals 2014. All Rights Reserved

Research & Reviews: A Journal of Drug Formulation, Development and Production

Volume 1, Issue 1

www.stmjournals.com

Development and Validation of a Gradient RP-HPLC

Method for Quantitative Determination of Potential

Manufacturing Impurities in New Drug Apronalide and

Pharmaceutical Formulations

Ritesh Mishra*, Hitesh Malvia, M. Asif Khan API Analytical Research & Development Department, Medilux Laboratories Pvt. Ltd. Pithampur,

Dist. Dhar. (M.P.), India

Abstract Three impurities in apronalide drug substance were detected and quantified using a simple isocratic reverse phase HPLC method. The chromatographic separation was

achieved on a Thermo Hypersil gold-CN, 100 A0 5 m, and 250X4.6 mm using a mobile

phase consisting of phosphate buffer (pH-4.6) - Methanol with UV detection at 210 nm and flow rate of 0.8 ml/min. The column temperature was maintained at 25

0C throughout

the analysis. This method was rapid, simple for separation of apronalide and potential

manufacturing impurities from each other in a 30 min run time. To the best of our knowledge, none of the method has been reported in the any pharmacopeia and literature

for separation of apronalide from the given set of related substances. The proposed method has been validated as per international guidelines on method validation and can

be used for the routine quality control analysis of apronalide as active pharmaceutical

ingredient (API) and pharmaceutical formulations. Also the method was determined to be robust with regards to the following parameters: mobile phase apparent pH; mobile

phase organic content; detection wavelength and time dependence of sample and standard stability.

Keywords: Apronalide, related Substances, HPLC, pharmaceutical formulation, drug

RRJoDFDP (2014) STM Journals 2014. All Rights Reserved

Research & Reviews: A Journal of Drug Formulation, Development and Production

Volume 1, Issue 1

www.stmjournals.com

In-house Preparation and Quality Control of a

Unani Formulation

Mohd. Tariq*, Shahid Shah Chaudhary, Ubaidul Hai, Abdullah Tauheed, Peerzada Mohd Younis, Syeda Anjum Farah

Department of Ilmul Saidla (Pharmacy), National Institute of Unani Medicine, Kottigepalya,

Bangalore-91, Karnataka, India

Abstract Shangraf (Cinnabar) is used in traditional systems like Unani and Chinese system of

medicine for the successful management of different diseases since time immemorial. In Unani system it is used in the form of kushta (Calcined product). This type of dosage

forms are easily absorbed in the human body and are highly efficacious in action hence,

are more popular and superior over other dosage forms. Kushta shangraf is highly

reputed as an effective aphrodisiac, nervine tonic and digestive. Till date no scientific

work has been carried out regarding establishment of quality control of kushta shangraf. The tests and observations used to monitor quality of kushta described in the Unani text

are highly subjective. So, this research work was aimed to physico-chemically evaluate kushta shangraf on classical as well as modern scientific procedures to establish its

quality control parameters. The results obtained were taken as standard for kushta

shangraf which will definitely help in ensuring batch to batch uniformity for further formulation in routine analysis.

Keywords: Kushta, shangraf, Unani

RRJoDFDP (2014) STM Journals 2014. All Rights Reserved

Research & Reviews: A Journal of Drug Formulation, Development and Production

Volume 1, Issue 1

www.stmjournals.com

Isolation, Identification and Molecular Cloning

of Chitinase Gene in Bacteria Isolated from

Crustacean Wastes

J.Senthil Kumar1*, Swathy Variar

1, K.S. Rishad

2

1Department of Biotechnology, Sri Krishna Arts and Science College, Coimbatore, India

2Unibiosys Biotech Research Lab, Cochin

Abstract This research envisaged cloning of genes encoding chitinases in bacteria isolated from

crustacean wastes and its transformation in E.coli by TOPO cloning method for complete

sequencing of partial gene. Chitin and chitinolytic enzymes are gaining importance for their biotechnological applications. Particularly, chitinases are used in both agricultural,

industrial applications and also in human health care. The chitinases are present in

chitin-containing microorganisms, bacteria and plants with a diversity of roles, such as chitin metabolism in growing hyphae, defence mechanisms in response to pathogens and

abiotic stress, in nutrition and parasitism. Apart from the application of chitinases as inhibitors and bio pesticides, the chitinases have been used for production of single cell

protein for animal and aquaculture feed, for the isolation of fungal protoplasts,

preparation of bioactive chito-oligosaccharides and for phytopathogen inhibition, reinforcement of plant defence. The success in employing chitinases for different aspects

depends on the supply of highly active preparations at reasonable cost. Therefore, the understanding of biochemistry and genetics of chitinolytic enzymes, their phylogenetic

relationships and methods of estimation will make them more useful in a variety of

processes in near future.

Keywords: Chitin, bacterial chitinase, chitinase Gene, TOPO, TA cloning,

sequence analysis

Research & Reviews A Journal of Drug FormulationDevelopment and validation of a gradient RP-HPLC -454-1269-1-RV-1FINALIn-house preparation and Quality control of a Unani Formulation-412-1166-1-SM (1)ISOLATION, IDENTIFICATION AND MOLECULAR CLONING -438-1221-1-RV