Charak College of Pharmacy and Research

SPECTROPHOTOMETRIC DETERMINATION OF ROSUVASTATIN CALCIUM IN MARKETED FORMULATION

About Authors
Narsinh N. Potdar*, Pranita P. Kore, Rishikesh V. Antre
Department of Pharmaceutical Chemistry,
JSPM’s Charak College of Pharmacy and Research, Wagholi,
Pune-Nagar Road, Pune-412 207 (India)

*narsinh_potdar@rediffmail.com

Abstract
Three new simple, economic spectrophotometric methods were developed for quantitative estimation of Rosuvastatin Calcium in bulk formulation. First method includes determination of Rosuvastatin Calcium at absorption maxima 252 nm, second method applied was area under curve for analysis of Rosuvastatin Calcium in the wavelength range of 247-257 nm and third method was first order derivative. Beer law obeyed in the concentration range of 5-35 μg/ml for all three methods. The correlation coefficients were found to be 0.974, 0.982 and 0.982by absorption maxima, area under curve and first order derivative spectra. Results of analysis were validated statistically and by performing recovery studies. The mean percent recoveries were found satisfactory for all three methods. The percentage label claim was found in the range of 100.28% to 101.01% .The proposed method was validated statistically and recovery studies.

INTERNAL AUDIT: A CRUCIAL OBJECTIVE TO ACHIEVE cGMP

ABOUT AUTHORS:
MR. Gunjegaonkar S.M., MR. Shelke T.T.
Assistance Professor.
Dept. of Pharmacology JSPM’s Charak College of Pharmacy and research,
Wagholi, Pune. Maharashtra.
*gunjeshiv@gmail.com

Internal audit is designed programme to seek any short comings in quality assurance systems and to suggest corrective action. It also monitors implementation and compliance with current good manufacturing practices.

A.OBJECTIVES:
1. Ensure  that  companies  operations  remain  compliance  with  and  implements  cGMP.
2. Assist in ensuring continuous quality improvement.
3. Cover all corrective aspects in production and quality control.

SOP PREPARATION AND FORMAT DESIGNING

ABOUT AUTHOR:
MR. Gunjegaonkar S.M.
Assistance Professor.
Dept. of Pharmacology JSPM’s Charak College of Pharmacy and Research, Wagholi, Pune, Maharashtra.
gunjeshiv@gmail.com

INTRODUCTION:
Standard operating procedures are integral part of all the pharmaceutical companies. To obtain the standard quality product intended for human and animal use, manufactured product must have gone through CGMP rules and regulations. Standard operating procedure is an also part of CGMP and GDP (Good documentation practices). Any process, procedure, activity being carried out at any time, at any step that has to perform according to SOP. Standard operating procedure must be written by a subject expert considering the GMP, working feasibility, accountability and authorized by authorized persons. In the face of a challenging regulatory environment, some leading Pharmaceutical companies have found ways to improve quality and costs significantly. To drive this kind of beneficial change, companies must first create a culture where quality objectives are transparent, well understood, and undoubtedly these goals can be achieved by following certain sets of procedures called as “Standard Operating Procedures” (SOP). Procedures are essential for any plant’s effectiveness and efficiency, and they are regulatory requirement in the Pharmaceutical Industry. A typical Pharmaceutical Industry has an average of 1200- 1300 SOPs. A Parenteral Drug Association (PDA) survey found that a typical pharmaceutical company must manage an average of 1250 CGMP-required SOPs and that the average maintenance burden is 15,000 h per firm.


REVIEW ON HEPATO-TOXICITY, HEPATOTOXICANTS AND LIVER PROTECTIVE PLANTS

ABOUT AUTHORS:
Mr. Gunjegaonkar shivshankar M., Mr. T.T. shelke
Dept. of Pharmacology, JSPMs Charak College of pharmacy and research,
Wagholi, Pune, Maharashtra
*gunjeshiv@gmail.com

1.  ABSTRACT
The 21st century has a paradigm shift from allopathic medicinal system to homeopathic and Ayurvedic medicinal system as it is been proved that the adverse effects or unwanted effects associated with the modern synthetic medicines are more than the herbal medicines. Worldwide acceptance of herbal medicine is increasing day by day and its beneficial effects are focused by scientific researches. The herbs play important role in management of diverse group of diseases ranging from acute fever to cardiac complications. The current review is taken with interest to gather the scientific information of plant which shows the hepatoprotective activity. Various scientific research reveals that these medicinal plant did not shows any acute toxicity even in high doses. The preliminary phytochemical studies show the presence of important secondary metabolites like flavonoids, alkaloids, tannins, rutin and rotenoids. Triterpenoid etc.