Submitted to
FACULTY OF PHARMACY
OSMANIA UNIVERSITY,
HYDERABAD 500007
[Link] – 1704-21-881-003
[Link]-1704-21-881-040
[Link] 1704-21-881-041
[Link]-IVth YEAR
Under the guidance of
[Link] Sagar
Department of Analysis
HOD
Sarojini Naidu Vanita Pharmacy Maha Vidyalaya
Tarnaka , Secunderabad-2025
NOVEL UV SPECTROPHOTOMETRIC METHOD DEVELOPMENT AND VALIDATION
FOR ESTIMATION
OF VONOPRAZAN IN TABLET DOSAGE FOR: EVALUATION OF GREENNESS OF
THE ANALYSIS
INTRODUCTION :
A technique used to measure how much UV (200–400 nm) and visible light (400–800 nm) is
absorbed by a substance.
Principle:
Based on Beer-Lambert Law – absorbance is directly proportional to concentration.
Working:
Light passes through a sample → some light is absorbed → detector measures the absorbance.
It Measures the Absorbance (A)Wavelength (λ in nm)
Applications:
• Pharma: Drug analysis
• Biology: DNA/protein study
• Food: Additive detection
• Chemistry: Compound identification
Advantages:Fast,Accurate, Non-destructive, Both qualitative & quantitative
LITERATURE REVIEW
MECHANISM OF ACTION
DRUG PROFILE
VONOPRAZAN
Synonym:
•1-[5-(2-fluorophenyl)-1-pyridin-3-ylsulfonylpyrrol-3-yl]-N-methylmethanamine
INDICATION:
•Vonoprazan, is a potassium-competitive acid blocker (P-CAB) approved by the
U.S. Food and Drug Administration (FDA)
STORAGE
vonoprazan, a potassium-competitive acid blocker (P-CAB), is used to
treat conditions like erosive esophagitis, gastroesophageal reflux disease
(GERD), and peptic ulcers. Its storage conditions vary depending on its
form—oral tablets or as a raw powder.
SIDE EFFECTS
Diarrhea
Stomach bloating or pain
Indigestion (dyspepsia)
PHARMACODYNAMICS:
🔹 Increases intragastric pH by inhibiting
gastric acid secretion.
🔹 Inhibitory effect improves with repeated
daily dosing.
🔹 After stopping the drug, pH remains
elevated for 24–48 hours.
🔹 No significant effect on QT interval (safe
cardiac profile).
🔹 High pKa (9.06) gives vonoprazan a
stronger positive charge.
🔹 This enables better accumulation in
gastric parietal cells.
🔹 Binds to H⁺,K⁺-ATPase enzyme
reversibly and competitively with K⁺.
🔹 More potent inhibitor than other PCABs
(like SCH28080) and PPIs (like
lansoprazole).
AIM AND OBJECTIVE
AIM:
To develop and validate a novel, eco-friendly UV spectrophotometric method for the estimation of Vonoprazan in tablet dosage
form, while evaluating the greenness of the analytical methodology.
OBJECTIVE:
1. Method Development: Develop a simple, sensitive, and specific UV spectrophotometric method for the estimation of
Vonoprazan in tablet dosage form.
2. Method Validation: Validate the developed method according to ICH guidelines, evaluating parameters such as accuracy,
precision, linearity, specificity, and robustness.
3. Greenness Evaluation: Assess the environmental impact and greenness of the developed method using suitable metrics (e.g.,
Analytical GREEnness (AGREE) or other relevant tools).
4. Comparison with Existing Methods: Compare the developed method with existing methods in terms of sensitivity,
specificity, and environmental sustainability.
5. Application to Pharmaceutical Analysis: Apply the developed method to estimate Vonoprazan in commercial tablet dosage
forms, demonstrating its suitability for routine pharmaceutical analysis.
MATERIALS & METHODS
Instruments used :
• SHIMADZU-1800 Double Beam UV-Visible Spectrophotometer
• LAB INDIA UV-Visible Spectrophotometer
• Digital LCD Ultrasonicator
• Digital balance
Reagents Used :
• Distilled Water
• Methanol
Drug Used:
Vonoprazan Tablet
Apparatus used :
• Quartz Square Cuvette
• Volumetric Flask
• whatman filter paper
• Pipettes
• Measuring Cyclinder
• Beakers
• mortar and pestle
Preparation of Standard Solution and Dilutions of
Vonoprazan
1. Preparation of Stock Solution:
• The powdered tablet equivalent to 20 mg of Vonoprazan was accurately weighed and
transferred into a 100 mL volumetric flask.
• To this, 50 mL of methanol was [Link] solution was shaken for 10 minutes to ensure
complete [Link] was then sonicated to improve solubility and extraction [Link]
solution was made up to 100 mL with methanol.
• The resulting solution was filtered to obtain a clear stock [Link] gave a concentration of
200 µg/mL (since 20 mg in 100 mL = 200 µg/mL)
2. Preparation of Primary stock Solution:
• 25 mL of the above stock solution was pipetted into a 50 mL volumetric flask.
• It was diluted up to the mark with methanol to get a solution of 100 µg/mL.
3. Preparation of secondary stock solution:
• From the 100 µg/mL solution, various concentrations were prepared as follows by pipetting the
required volume and making up to 10 mL with distilled water
• Pipetted out 0.5ml , 1ml , 2ml , 4ml , 6ml , 8ml , 10ml of Primary stock Solution and makeup the
volume with distilled water to obtain 5μg/ml, 10μg/ml, 20μg/ml, 40μg/ml. 60μg/ml, 80μg/ml and
METHOD VALIDATION:
Linearity : Concentration Absorbance
(µg/ml) at 206nm
5μg/ml 0.295
10μg/ml 0.3652
20μg/ml 0.398
40μg/ml 0.462
60μg/ml 0.5427
80μg/ml 0.6231
100μg/ml 0.7261