October 2012

About Authors:
Krunal Parikh^1*, Maheshkumar Kataria^2
1 M.Pharm, Quality Assurance,
²Assistant professor, Department of pharmaceutics,
Seth G.L. Bihani S.D. College of Technical Education,
Institute of Pharmaceutical Sciences and Drug Research,
Sri Ganganagar, Rajasthan, INDIA
*Krunal_2922@yahoo.in

ABSTRACT
The Quality System regulation requires that “when computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol.” This has been a regulatory requirement for GMP since 1978. In addition to the above validation requirement, computer systems that implement part of a regulated manufacturer’s production processes or quality system (or that are used to create and maintain records required by any other FDA regulation) are subject to the Electronic Records, Electronic Signatures regulation. This regulation establishes additional security, data integrity, and validation requirements when records are created or maintained electronically. These additional Part 11 requirements should be carefully considered and included in system requirements and software requirements for any automated record keeping systems.

About Authors:
Nirav D.Langhneja^1*, Tushar  Vaja¹, Dr. Vijay K. Parmar^2
1M.Pharm, Department of Pharmaceutical Sciences,
²Associate Professor, Department of Pharmaceutical Sciences,
Sardar Patel University,
Vallabh Vidyanagar-388120, Gujarat.
*laghnejanirav@gmail.com

INTRODUCTION
Sildenafil citrate 1-[[3-(6,7-Dihydro -1-methyl- 7-oxo-3-propyl -1H-pyrazolo [4,3-d] pyrimidin-5-yl) -4-ethoxyphenyl]sulphonyl]-4-methyl piperazine citrate and it is a popularly known as Viagra .It is a compound of the pyrazolo-pyrimidinyl-methyl piperazine class, and is used to treat male erectile dysfunction (Boolell.M et.al 1996, Morales. A, et.al 1998). It is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5  inhibitor. The structural formulae is C22H30N6O4S. It is an ampholyte with pKa value 4 (pirydinium ion) and 8.8 (benzimidazole). Sildenafil citrate is twice as soluble in methanol than in water. Its solubility decreases with pH up to 9 when it starts to increase again. Sildenafil citrate could be determined by several analytical techniques, Densitometry, spectrophotometry, colorimetry, HPLC, GC-MS, MEKC and capillary electrophoresis.

The National Institute of Pharmaceutical Education & Research (NIPER) is an Institute of national importance established by an Act of Parliament under the aegis of Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India. The main thrust areas of the institute are Tuberculosis, Malaria, Leishmaniasis and Diabetes.

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About Authors:
Sanober Parveen*, Maju Vyas Singh
Delhi institute of Pharmaceutical Sciences & research University (DIPSAR), Delhi.
*sanober.parveen@gmail.com

Abstract
The present study was aimed Pharmacognostic and preliminary phytochemical study of the fresh fruits of Alstonia scholaris, belonging to family Apocynaceae.The pharmacognostic investigation were carried out in terms of macroscopic, microscopic and physical parameters. The extract obtained after successive Soxhlet extraction of dried fruit using n-hexane, chloroform, methanol and water were subjected to a preliminary phytochemical screening which revealed the presence of alkaloids, carbohydrate, glycoside, terpenoids and flavanoids.