Pharmaceutical Analysis: Assay of Active Ingredients in Tablets
A validated HPLC method for quantitative analysis of active pharmaceutical ingredients in tablet formulations.
Pharmaceutical Analysis: Assay of Active Ingredients in Tablets Article ID: AN-001 Category: Application Notes Subcategory: Pharmaceutical Analysis Author: Manus AI Published Date: 2026-02-03 --- Introduction The accurate quantification of Active Pharmaceutical Ingredients (APIs) in tablet formulations is a critical quality control step in the pharmaceutical industry. It ensures that each tablet contains the correct dosage, which is essential for drug safety and efficacy. High-Performance Liquid Chromatography (HPLC) with UV detection is the most widely used technique for this purpose due to its high specificity, accuracy, and precision. This application note describes a robust and reliable reversed-phase HPLC (RP-HPLC) method for the assay of a common API, Acetaminophen, in a commercial tablet formulation. This method is suitable for quality control laboratories in regions such as Pakistan, the Middle East, and Russia, where pharmaceutical manufacturing and quality assurance are of high importance. Experimental Conditions | Parameter | Condition | | :--- | :--- | | Instrument | Standard HPLC system with UV Detector | | Column | C18, 5 µm, 4.6 x 150 mm | | Mobile Phase | Methanol : Water (60:40, v/v) | | Flow Rate | 1.0 mL/min | | Column Temperature | 30 °C | | Detection Wavelength | 243 nm | | Injection Volume | 10 µL | Sample Preparation Standard Solution Preparation 1. Accurately weigh about 100 mg of Acetaminophen reference standard and transfer it to a 100 mL volumetric flask. 2. Add about 70 mL of mobile phase and sonicate for 10 minutes to dissolve. 3. Dilute to volume with the mobile phase to obtain a standard solution of 1000 µg/mL. 4. Further dilute this solution to obtain a working standard of 100 µg/mL. Sample Solution Preparation 1. Weigh and finely powder