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  • Nalytical Ethod Evelopment ND Ethod Alidation F PH Ndependent Torvastatin Alcium Y - Isible Pectroscopic Ethod

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    dasubhai
    5 просмотров8 страниц
    An analytical method was developed and validated for the quantification of atorvastatin calcium using UV-visible spectroscopy. The method utilized a wavelength of 246.4 nm to measure atorvastatin calcium in ethyl alcohol. Standard solutions of atorvastatin calcium ranging from 20-50 μg/ml were prepared and used to validate the method. The method demonstrated good precision, linearity, ruggedness and robustness making it suitable for the quantification of atorvastatin calcium.

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    Оригинальное название

    analytical method

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    An analytical method was developed and validated for the quantification of atorvastatin calcium using UV-visible spectroscopy. The method utilized a wavelength of 246.4 nm to measure atorvastatin calcium in ethyl alcohol. Standard solutions of atorvastatin calcium ranging from 20-50 μg/ml were prepared and used to validate the method. The method demonstrated good precision, linearity, ruggedness and robustness making it suitable for the quantification of atorvastatin calcium.

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    © All Rights Reserved
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    5 просмотров8 страниц

    Nalytical Ethod Evelopment ND Ethod Alidation F PH Ndependent Torvastatin Alcium Y - Isible Pectroscopic Ethod

    Загружено:

    dasubhai
    An analytical method was developed and validated for the quantification of atorvastatin calcium using UV-visible spectroscopy. The method utilized a wavelength of 246.4 nm to measure atorvastatin calcium in ethyl alcohol. Standard solutions of atorvastatin calcium ranging from 20-50 μg/ml were prepared and used to validate the method. The method demonstrated good precision, linearity, ruggedness and robustness making it suitable for the quantification of atorvastatin calcium.

    Авторское право:

    © All Rights Reserved
    Скачайте в формате PPTX, PDF, TXT или читайте онлайн в Scribd
    Отметить как неприемлемый контент
    из 8

    ANALYTICAL METHOD

    DEVELOPMENT AND
    METHOD VALIDATION OF
    pH INDEPENDENT
    ATORVASTATIN CALCIUM BY
    UV-VISIBLE
    SPECTROSCOPIC METHOD

    DRUG PROFILE
    Molecular formula: (C33H34FN2O5)2Ca.3H2O
    Molecular weight: 1209.42
    Nature of the drug and pharmaceutical
    action:
    Synthetic
    cholesterol-lowering
    agent and also called HMG-CoA(3-hydroxy3-methylglutaryl-coenzyme-coenzyme A)

    ANALYTICAL METHOD DEVELOPMENT


    Wavelength of the drug sample: 246.4nm
    Selection of liquid diluent: ethyl alcohol of
    AR-grade
    which
    is
    cent
    percent
    satisfactory to be used as diluent
    Instrument utilised: SHEMADZU-1700 UV
    Vis spectrophotometer

    100mg drug in 100ml


    C2H5OH(1000g/ml consent)

    10% dilution of drug solution to get the


    concentration of 100g/ml solution.

    Preparation of individual concentrations


    i.e. 20,30,40 & 50g/ml solution.

    ANALYTICAL METHOD VALIDATION OF


    PURE DRUG
    Validation
    protocol
    to
    perform
    following analytical method validation
    through USP:

    RESULTS
    %RSD is 0.565% (in case of system
    precision): satisfactory result.
    In method precision %RSD is 0.17%
    which is passed.
    Linearity shows correlation
    coefficient= 1
    Ruggedness.

    SUMMARY & CONCLUSION


    This method which is developed
    is well precise, well rugged, well
    robust, simple as well as very
    precise
    one
    which
    obeys
    satisfactory linear results.

    REFERENCES
    U.S. FDA Guidance for Industry
    (draft) Analytical
    Procedures

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