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prasad presentation

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prasadkushare7
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Dattakala Shikshan Sansta’s

Dattakala College Of
Pharmacy
Topic
“UV Spectrophotometric
estimation and validation of
Metformin”
Presented by,
Under the guidance Of,
Mr.Sumit Rajendra Lokare
ROLL NO: 51 Prof.Priti.R.Kale
Final Year, Sem VII (Quality Assurance Techniques)
Content
• Abbreviations
• List of tablets and
figures
• Abstract
• Introduction to UV
spectroscopy
• Estimation and
validation
• Introduction to
Abbrevation
• UV - Ultraviolent
• API- Active Pharmaceutical Ingredient
• ICH- The International Council for
• Harmonization Of Technical Requirements
• for Pharmaceuticals for Human Use.
• LOD -Limit of Detection
• LOQ -Limit of Qualification
• US FDA -United States Food and Drug
Administration
• HTZ -Hertz
• IR -Infrared
• NMR- Nuclear magnetic resonance
• TLC- Thin layer chromatography
• HPTLC -High performance thin
layer chromatographyUV
Abstrac
t Beers
•
ml
law was obeyed in the range of 2-16 μg/

,with molar
• absorptivity of 1.28x104 L.mol-1.cm-1 ,relative
standard deviation of the method was less
than 1.8%,
• and accuracy (average recovery %) was 100 ±
1.0
.The method was successfully applied to the
• estimation of metformin hydrochloride
in pharmaceutical
Introduction to UVSpectroscopy

• UV visisble spectroscopy is widely


used analytical technique also
known as Ultraviolent visible
spectroscopy.
• This is a technique that measures the amount of
discrete wavelengts of UV or visible light that
are absorbed by or transmitted
through a sample in comparision to reference
Types of UV-Vis
Spectrophotometer
: There are 3 classifications of UV-Vis
•
spectrophotometer. They are as follows:
• 1. Double beam spectrophotometer
• 2. Split beam spectrophotometer
• 3. Single Beam Spectrophotometer
Light
Source:
• Tungsten filament lamps and Hydrogen -
Deutorium lamps are most widely used
and suitable light
• sources as they cover the whole UV
region.
Monochromator
: Monochromators are generally composed of
•
prisms and slits.
• The most of the spectrophotometers are
double beam spectrophotometers.
Detector
: There are mainly 3 types of detector which
•
are
widely used in UV spectrophotometers
1. Barrier Layer Cell
2. Photo Cell
3. Photomultiplier Tube
• Recording system
• The signal from the photomultiplier tube is
received by the recording system.
Cuvette
s
• The container for the sample and reference solution must
transparent
be to radiation which will pass them
through .
• Quartz or fused silica cuvettes are required for
spectroscopy in UV region.
Analytical Method Development
SOLVENT WAVELENGTH
Water 205nm
Methanol 210 nm

Ethanol 210 nm
Method of
Ether 210 nm developmen
Chloroform 245 nm t
Carbon tetrachloride 265 nm

Cyclohexane 210 nm
Estimation and
validation
• Uv spectrophotometric estimation is a term that refers to
analytical analysis of spectra to comparerelative
absorption or emission of different wavelengths of light.
• Parameters of
validation are :

• 1. Linearity
• 2. Limit of detection
• 3. Limit of quantitation
• 4. Trueness
• 5. Accuracy
• 6. Robustness
• 7. Ruggedness
• Accuracy :
Accuracy is expressed as the nearness of
agreement between the values found and values
that are already available.
• Precision :
The exactness of analytical procedure
expresses the nearness of agreement between group
of measurement obtained from different sampling of
uniform sample under neath the prescribed
• Range :
It can be characterized as interval
amongst upper and lower quantity of analyte
in the sample.
• Ruggedness :
Is the degree of reproducibility under
different situations such as different
laboratories, analyst, environmental
conditions.
Introduction of
Metformin
• Metformin hydrochloride is an oral anti
hyperglycemic agent used to lower blood
glucose in patients suffering from diabetes of
non-insulin dependent. Metformin
hydrochloride
chemically is known as 1,1-Dimethyl
biguanide hydrochloride with a molecular formula
of C4H12Cl N5
Pharmacology of
• metformin
Metformin is an agent of antihyperlyacemic which
in people withtype 2 diabetis increseases
glucose resistance,reducing both prospandal
plasma and glucose.
Mechanism of metformin
Pharmacokinetic
• s
Absorption :Absorbed over 6hrs.peak
action occurs 3hrs after oral administration
• Distribution : Steady state plasma
concentration
• of metformin is reached within 24-28 hrs.
• Metabolism : Metformin is not metabolised.
• Protein binding : Metformin is negligibly bund
to plasma proteins
•
ADR’s of Metformin
Conclusion

• The proposed methods are simple, sensitive, and costeffective. Validated


in terms of precision, linearity andaccuracy.
• The results are reproducible, and can be usedsuccessfully for the
estimation
of Metformin in bulk and its pharmaceutical formulations
• Analytical method development mainly involves method which is precise,
simple, accurate and having advantages over existing methods
References
1.ICH-Guidelines Q2 (R1), Validation of Analytical Procedures: Text and
Methodology. 2005
[Google Scholar]1. Nief Rahman Ahmed (2012) Facial
visible spectrophotometric
2.Rajia SN, Dewan TA, Yeakuty MJ: Development and validation of
UV spectrophotometric method
for quantitative estimation
3. Parekh RR, Patel PH, Patel CD, Patel KS, Patel HN: Development
and
Validation of UV
Spectrophotometric method for estimation
4.Lafutidine in bulk and Pharmaceutical dosage form.
International
Journal of Drug Development &
Research 2012, 4 (1): 329
5. Jamakhandi C M, Javali C, Disouza J I, Chougule U S and Mullani
A K, Int
JP

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