Green gradient RP-HPLC with variable flow rate for simultaneous analysis of paracetamol and ascorbic acid in pharmaceuticals
Year: 2026
Type: article
Abstract: Paracetamol and ascorbic acid are widely incorporated into combination pharmaceutical formulations for the symptomatic treatment of cold and influenza. The present study reports the development and validation of a green, stability-indicating RP-HPLC method for the simultaneous quantification of these active pharmaceutical ingredients in bulk drug materials, intravenous infusion preparations, and effervescent tablet formulations using a microscale sample preparation strategy. Method validation was conducted in accordance with the ICH Q2(R2) guideline. Separation was achieved on a C18 chromatographic column using gradient elution with 0.015 M potassium dihydrogen phosphate buffer (pH 3.0) and methanol as the mobile phase components. A variable flow program ranging from 1.0 to 1.2 mL/min was applied, and analytes were monitored at 245 nm using a diode array detector maintained at 25 ± 2 °C. The method showed excellent linearity within concentration ranges of 3.2–29.3 µg/mL for ascorbic acid and 5.5–48.5 µg/mL for paracetamol. Forced degradation studies demonstrated effective separation of both analytes from degradation products, confirming the stability-indicating nature of the method. Green analytical assessment using AES, AGREE, MoGAPI, BAGI, and RGB12 yielded scores of 78, 0.60, 74, 80, and 96.7%, respectively.
Source: Scientific Reports
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: gold
Estimated APC paid: $2,690
OpenAlex ID: W7225794666
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