Combining baclofen with ibuprofen offers synergistic pain relief by targeting both muscle spasms
and inflammation, enhancing efficacy in managing musculoskeletal conditions. This study aims to
develop and validate an analytical method for the separation and simultaneous determination of
ibuprofen and baclofen in combination using high-performance liquid chromatography (HPLC) in
pharmaceutical dosage forms. An HPLC analytical method was developed to simultaneously
quantify ibuprofen and baclofen. The optimized method was validated in accordance with the
International Conference on Harmonization (ICH) guidelines. The method was tested for
validation parameters, including specificity, accuracy, precision, linear range, limit of detection,
lower limit of quantification, and robustness. A simple HPLC method was developed to separate
two active ingredients using a C18 stationary phase column (25 cm × 0.46 cm, 5 μm). The mobile
phase consisted of methanol: buffer (pH 3 ± 0.05), and acetonitrile in a ratio of 5:30:65 (%v/v).
The analysis was performed at 25 °C with a 1.5 mL/min flow rate. A 20 μL sample volume was
injected and detected at 265 nm. The validation method was specific, precise, and accurate. The
average recovery of the two ingredients was 100.5% [99.1-102.0]. The repeated tests of the two
compounds at different concentrations showed a percentage relative standard deviation (%RSD) of
less than 1%. The method demonstrated linearity for both ibuprofen and baclofen, with an R²
value of 0.99. The linearity range was 12.5-150 μg/mL for baclofen, and was 100-1800 μg/mL for
ibuprofen. The lower limit of quantification (LLOQ) was 7 and 6 μg/mL for ibuprofen and
baclofen, respectively. The limit of detection (LOD) was 2 μg/mL for both ingredients. The
developed method is simple, rapid, precise, and accurate. It can be used for routine analysis of a
combination of ibuprofen and baclofen in pharmaceutical dosage forms.
Keywords: HPLC, Ibuprofen, Baclofen, Validation, ICH, Pharmaceutical dosage form
Introduction
Ibuprofen, also known as [-methyl-4-(2-
methylpropyl)-benzene acetic acid], is a
nonsteroidal anti-inflammatory medication
(NSAID). It is commonly used as an analgesic
in treating mild to moderate pain and
rheumatoid arthritis [1]. Ibuprofen is a
crystalline substance with a melting point of
77–78 °C and typically appears in a needle-
shaped crystal form. It is a slightly polar,
lipophilic compound with a LogP value of

العنوان

Pakistan Journal of Analytical and Environmental Chemistry

الناشر

UNIV SINDH, NATL CENTRE EXCELLENCE ANALYTICAL CHEMISTRY

بلد الناشر

باكستان

Indexing

Thomson Reuters

معامل التأثير

0,4

نوع المنشور

إلكتروني فقط

المجلد

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السنة

2025

الصفحات

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