Abstract
Different signal-transforming algorithms were applied for UV spectrophotometric analysis of paracetamol, ibuprofen, and caffeine in ternary mixtures. Phosphate buffer pH 7.2 was used as the spectrophotometric solvent. Severe overlapping spectra could be resolved into individual bands in the range of wavelengths 200–300 nm by using Savitzky–Golay smoothing and differentiation, trigonometric Fourier series, and mother wavelet functions (i.e., sym6, haar, coif3, and mexh). To optimize spectral recoveries, the concentration of various types of divisors (single, double, and successive) was tested. The developed spectrophotometric methods showed linearity over the ranges 20–40 mg/L for paracetamol, 12–32 mg/L for ibuprofen, and 1–3.5 mg/L for caffeine (R2 > 0.990). They could be successfully applied to the assay and dissolution test of paracetamol, ibuprofen, and caffeine in their combined tablets and capsules, with accuracy (99.1–101.5% recovery) and precision (RSD < 2%). For comparison, an isocratic RP-HPLC analysis was also developed and validated on an Agilent ZORBAX Eclipse XDB–C18 (150 × 4.6 mm, 5 µm) at an ambient temperature. A mixture of methanol : phosphate buffer 0.01 M pH 3 (30 : 70 v/v) was used as the mobile phase delivered at 2 mL/min, and the effluent was monitored at 225 nm. It was shown that spectrophotometric data were statistically comparable to HPLC (p > 0.05), suggesting possible interchange between UV spectrophotometric and HPLC methods for routine analysis of paracetamol, ibuprofen, and caffeine in their solid pharmaceutical dosage forms.
Highlights
Combined pharmaceutical dosage forms have been more and more manufactured and used for better treatment outcome. ere was considerable clinical evidence that a multicomponent therapy is more efficient than monocomponent therapies because it can expand the array of therapeutic options, facilitate the completeness of therapeutic effect, and permit the doctors (and, in self-medication with over-the-counter (OTC) medications, the patients themselves) to personalize any treatment based on the patient’s specific needs [1].Paracetamol (a.k.a. acetaminophen, Figure 1(a)) was popularly used to combat fever in the 1950s and becomes the antipyretic and analgesic of first choice in most countries [2]
Signal transforms demonstrated to be an encouraging means to deconvolve UV overlapping spectra of ternary and quaternary mixtures [30,31,32,33]. Based on this signal-processing approach, the present study aims at developing analytical methods based on signal-transforming UV ratio spectra for the simultaneous determination of paracetamol, ibuprofen, and caffeine in coformulated ternary mixtures, using RP-HPLC as a reference method
Validation and Application. e validity of all the developed methods was assessed in terms of precision, accuracy, and linearity according to ICH guidelines [49]. e repeatability was evaluated by RSD for six replicate determinations of the same sample. e accuracy was evaluated by % recovery using the standard addition technique
Summary
Combined pharmaceutical dosage forms have been more and more manufactured and used for better treatment outcome. ere was considerable clinical evidence that a multicomponent therapy (like combined analgesics) is more efficient than monocomponent therapies because it can expand the array of therapeutic options, facilitate the completeness of therapeutic effect, and permit the doctors (and, in self-medication with over-the-counter (OTC) medications, the patients themselves) to personalize any treatment based on the patient’s specific needs [1]. Signal transforms (derivative, Fourier, and wavelet) demonstrated to be an encouraging means to deconvolve UV overlapping spectra of ternary and quaternary mixtures [30,31,32,33] Based on this signal-processing approach, the present study aims at developing analytical methods based on signal-transforming UV ratio spectra for the simultaneous determination of paracetamol, ibuprofen, and caffeine in coformulated ternary mixtures, using RP-HPLC as a reference method. It assesses the applicability of developed UV spectrophotometric methods for both assay and dissolution test of paracetamol, ibuprofen, and caffeine in their combined solid pharmaceutical dosage forms
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