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Charak College of Pharmacy and Research

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Clinical research courses

  • 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.

  • HANDLING OF MARKET COMPLAINTS, COMPLAINT INFORMATION FORM AND MARKET COMPLAINT INVESTIGATION REPORT

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

     

     

  • 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.

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