Research & Reviews:
A Journal of Drug Formulation, Development & Production RRJoDFDP
Jan - April 2014
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Research & Reviews: A Journal of Drug Formulation, Development and Production Focus and Scope Covers † Drug Development † Novel drug delivery systems † International Drug regulatory Affair † Pharmacodynamics & pharmacokinetics † Medicinal Chemistry †
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Dr. Abhay Dharamsi Professor and Head Department of Pharmaceutics, Maliba Pharmacy College, Surat, Gujarat, India.
Dr. Atla Srinivasa Rao Professor & HOD Dept. of Pharmaceutical Analysis & QA Shri Vishnu College of Pharmacy , A.P., India.
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Dr. Bharat Bhusan Subudhi Associate Professor, School of Pharmaceutical Sciences, Siksha O Anusandhan University, Bhubaneswar, India.
Dr. Bhavin P. Marolia Assistant Professor, Dept. of Quality Assurance & Pharmaceutical Analysis, Maliba Pharmacy College UKA Tarsadia University, Tarsadi.
Dr. Chiau Long Lecturer, Faculty of Pharmacy, Universiti T eknologi MARA, Puncak Alam, Selangor, Malaysia.
Mrs. Divya Suares Assistant professor, NMIMS University, India.
Dr. George D Geromichalos Head, Molecular Modeling & Drug Design, Symeonidion Research Center Theagenion Cancer Hospital, Greece.
Dr. Jayarajakumar Kalaimani Faculty of Pharmacy, AIMST University, Bedong,Malaysia.
Dr. K.R. Arya Principal Scientist, Botany Division, CDRI, Lucknow, India.
Dr. Kashmira Gohil Professor and HOD, Shree Dhanvantari Pharmacy College (SDPC), Surat, Gujarat, India.
Dr. Koteshwara K.B Professor, Department of Pharmaceutics, Manipal College of Pharmaceutical Sciences, Manipal University,India.
Editorial Board
Dr. Mahalaxmi Rathnanand Associate Professor ,Dept of Pharmaceutics Manipal College of Pharmaceutical Sciences, Manipal, India.
Dr. Mohd Shihabuddin B. A. Noorden Senior Lecturer Faculty of Pharmacy, Universiti Teknologi MARA, 42300 Puncak Alam, Selangor, Malaysia.
Dr. Mohamed Salama Professor,Faculty of Pharmacy, UiTM , Malaysia.
Dr. Neeraj Kumar Fuloria Faculty of Pharmacy, AIMST University, Malysia, Malaysia.
Dr. Poonam Singh Scientist CSIR-Central Drug Research Institute, Lucknow.
Dr. Pranav Shah Associate Professor, Maliba Pharmacy College, Maliba Campus, Surat, Gujarat, India.
Dr. R.K Singh Senior Principal Scientist, CDRI, Lucknow, India.
Dr. Rabi Bhatta Scientist Lab no: PCN-108 Pharmacokinetic and Metabolism Division CSIR-Central Drug Research Institute, Lucknow, India.
Dr. Rama Pati Tripathi Professor AcSIR, Cheif Scientist CSIR-Central Drug Rsearch Institute Medicinal and process chemistry Division CSIR Lucknow India.
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Dr. Sanghapal D. Sawant 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.
Dr. Sridevi Chigurupati Senior Lecturer Faculty of Pharmacy, AIMST University, Malaysia.
Mr. Soh Yee Chang Faculty of Pharmacy UiTM Puncak Alam Campus Malaysia.
Dr. Suneel .I.Majagi Associate Professor Department of Pharmacology J.N.Medical College Belgaum-590010. Karnataka.
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. 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.
Director's Desk
STM JOURNALS
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
Research & Reviews: A Journal of Drug Formulation, Development and Production
Contents
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
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 Âľm, 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 250C 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) Š 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) Š 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 Variar1, K.S. Rishad2 1
Department of Biotechnology, Sri Krishna Arts and Science College, Coimbatore, India 2 Unibiosys 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
RRJoDFDP (2014) Š STM Journals 2014. All Rights Reserved