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

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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dasubhai
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18 views

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

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.

Uploaded by

dasubhai
Copyright
© © All Rights Reserved
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd
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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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