Standard Operating Procedure for UV-Vis Spectroscopy for Dissolution Analysis

Department	Quality Control
SOP No.	SOP/TAB/107/2025
Supersedes	SOP/TAB/107/2022
Page No.	Page 1 of 7
Issue Date	01/03/2026
Effective Date	06/03/2026
Review Date	01/03/2027

1. Purpose

To define the procedure for using UV-Vis spectroscopy for dissolution analysis of tablets, ensuring that the dissolution rate and release profile of the active pharmaceutical ingredient (API) is accurately quantified.

2. Scope

This SOP applies to the use of UV-Vis spectroscopy in the quality control laboratory for the analysis of dissolution samples from tablet formulations to evaluate API release.

3. Responsibilities

• Quality Control (QC): Responsible for performing UV-Vis spectroscopy analysis on dissolution samples, ensuring the results meet the required specifications for drug release.
• Quality Assurance (QA): Ensures that the UV-Vis dissolution analysis procedure is followed correctly and reviews the results for regulatory compliance.
• Laboratory Personnel: Responsible for preparing the dissolution samples, operating the UV-Vis spectrophotometer, and recording results accurately.

4. Accountability

The QC Manager is accountable for ensuring that UV-Vis spectroscopy analysis is performed accurately, and the results are interpreted according to established guidelines. The QA Manager is responsible for reviewing and approving the final results.

5. Procedure

5.1 Sample Preparation

1. Prepare the dissolution medium as per the dissolution test method for the specific tablet formulation (e.g., pH 1.2, 4.5, or 6.8 buffer solution).
2. After the dissolution test is completed, collect samples at the predefined time points (e.g., 15 min, 30 min, 1 hr, 2 hr, 4 hr, and 8 hr), ensuring that the samples are filtered to remove any undissolved material.
3. Ensure that the sample is diluted, if necessary, to bring the API concentration within the absorbance range of the UV-Vis spectrophotometer.

5.2 Calibration and Instrument Setup

1. Calibrate the UV-Vis spectrophotometer using a standard solution of known concentration of the API or an appropriate calibration standard.
2. Set the wavelength to the absorbance maximum (λmax) of the API, typically between 200–300 nm, based on the API’s UV absorption profile.
3. Check the instrument’s baseline by running a blank sample of the dissolution medium and ensuring the absorbance is zero at the selected wavelength.

5.3 Performing UV-Vis Spectroscopy

1. Measure the absorbance of each dissolution sample at the chosen wavelength.
2. Record the absorbance readings for each sample, ensuring that the instrument settings remain consistent for all measurements.
3. If the sample absorbance exceeds the linear range of the instrument, dilute the sample and re-test to ensure accurate measurements.

5.4 Data Analysis and Calculation

1. Use the Beer-Lambert law to calculate the concentration of the API in the dissolution sample:
   • Concentration (C) = Absorbance (A) / (ε × l)
   • Where ε is the molar absorptivity (extinction coefficient) of the API, and l is the path length of the cuvette (usually 1 cm).
   • Calculate the cumulative percentage of the API released at each time point based on the concentration obtained from the UV absorbance readings.
   • Plot the dissolution profile (API released versus time) and compare the results to the established dissolution criteria for the formulation.

5.5 Acceptance Criteria

1. Ensure that the dissolution profile meets the predefined release criteria, such as the percentage of API released at each time point (e.g., 80% release within 30 minutes for immediate release tablets).
2. If the dissolution profile does not meet the acceptance criteria, investigate the cause and document the findings in the deviation report (Annexure-1).
3. If necessary, repeat the dissolution analysis or take corrective actions based on the investigation.

5.6 Documentation and Record-Keeping

1. Document the UV-Vis spectroscopy results, including the absorbance readings, concentrations, and dissolution profiles, in the batch record (Annexure-2).
2. Ensure that all records are signed, dated, and stored according to the company’s record retention policy for future audits and inspections.
3. Maintain raw data, including spectra and calibration data, for regulatory compliance and future reference.

5.7 Post-Test Actions

1. Clean the UV-Vis spectrophotometer and sample holders after each use, ensuring that no contamination remains from previous samples.
2. Dispose of any used samples or reagents according to the company’s waste disposal procedures.
3. Ensure that the UV-Vis instrument is maintained and calibrated regularly according to the instrument’s SOP.

6. Abbreviations

• SOP: Standard Operating Procedure
• GMP: Good Manufacturing Practice
• QC: Quality Control
• QA: Quality Assurance
• UV-Vis: Ultraviolet-Visible
• API: Active Pharmaceutical Ingredient

7. Documents

1. Batch Record (Annexure-2)
2. Deviation Report (Annexure-1)

8. References

• USP <711> – Dissolution Testing of Tablets
• 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
• European Pharmacopoeia (EP) – UV-Vis Spectroscopy Specifications

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Deviation Report

Deviation Date	Batch Number	Deviation Description	Corrective Action	Responsible Person
15/12/2025	Batch 001	Dissolution profile did not meet target release	Investigated and adjusted formulation	John Doe

Annexure-2: Batch Record

Batch Number	Time (min)	Absorbance	API Released (%)	Result
Batch 001	30	0.350	75%	Pass

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/01/2024	1.0	Initial Version	New SOP Creation	QA Head
01/02/2025	2.0	Updated Data Analysis Process	Improved dissolution profile analysis	QA Head