A multipurpose eco-friendly separation-based approach for appraisal of a single-pill triple-action cramp relief combination; impurity separation, dissolution study and greenness/whiteness assessment

• Published in: Microchemical journal Vol. 198; p. 110062
• Main Authors: Ibrahim, Engy A., Saad, Samah S., Hegazy, Maha A., Fattah, Laila E. Abdel, Marzouk, Hoda M.
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 01.03.2024
• Subjects: Dissolution profiling; Greenness assessment; HPLC-UV; HPTLC-densitometry; Impurity profiling; Multi-component pharmaceutical formulation; Whiteness assessment; Impurity profiling; Greenness assessment; Multi-component pharmaceutical formulation; HPTLC-densitometry; Dissolution profiling; HPLC-UV; Whiteness assessment
• ISSN: 0026-265X; 1095-9149
• DOI: 10.1016/j.microc.2024.110062

[Display omitted] •A triple-action cramp relief over-the-counter pharmaceutical formulation of paracetamol, caffeine and pyrilamine maleate.•Novel eco-friendly HPTLC-densitometry and HPLC-UV methods for mixture analysis and purity assessment.•Successful applicability in assaying and quality control of the market tablets.•Dissolution profiling of Midol® Complete caplets as an in-vivo efficiency indicator.•Affirming methods sustainability via implementing various greenness and whiteness assessment tools. Over the years, several single-pill combinations have been produced and utilized as an alternative option for treatment of the signs and symptoms ofPrimary dysmenorrhea. The presence of multiple drugs together poses a challenge for analysts regarding analysis, making it a significant hurdle to overcome. A combination of paracetamol (PAR), caffeine (CAF), and pyrilamine maleate (PYR) is commonly recommended as an over-the-counter triple-action treatment to alleviate mild to moderate premenstrual syndrome symptoms. This study presented two liquid chromatographic methods that simultaneously determine PAR, CAF, and PYR in Midol® Complete caplets along with three officially recognized impurities, namely, p-aminophenol, theophylline, andp-anisaldehyde. The initial approach employed high-performance thin-layer chromatography alongside a densitometric scanning technique. The experimental setup utilized silica gel HPTLC plates as the stationary phase, and ethyl acetate: aqueous ammonium hydroxide (10.0:0.1, v/v) mixture as the developing system. The densitometric scanning was conducted at a wavelength of 210.0 nm. The second approach, developing high-performance liquid chromatographic method coupled with ultraviolet detection. Inertsil ODS-3 C18 column (250 × 4.6 mm, 5 μm) was used to separate the six compounds effectively. For the experimental procedure, an isocratic elution method was chosen with a mobile phase consisting of a mixture of 0.02 M potassium dihydrogen phosphate buffer acidified with o-phosphoric acid (pH 3.0), and methanol (80:20, v/v) at a flow rate of 1.0 mL/min. UV detection was carried out at a wavelength of 210.0 nm. The two proposed methods have been validated in accordance with ICH recommendations. In addition, the suggested HPLC-UV technique was used to track the release profile of the cited drugs during the in-vitro study. The developed methods were assessed and compared for their environmental impact using various greenness evaluation tools. Additionally, the recently introduced RGB12 model was used to study the whiteness features of the suggested methods. The proposed methods yielded desirable outcomes and are sustainable, simple, affordable, and low-cost, which highly recommends their use in quality control labs.