Enoxaparin sodium
is an anticoagulant medication that
is used as
a blood thinning agent. It is mostly used for the treatment and prevention
of deep vein thrombosis (DVT) and pulmonary embolism (PE). It is also
used in certain surgeries and during pregnancy. For the treatment
of acute coronary syndrome (ACS) and heart attacks, it may be used.
Enoxaparin sodium was validated by the RP-HPLC method. A simple RP-HPLC
method was developed in a single HPLC run in a dry powder injection
formulation. All injections of HPLC sample were 20 μL volume.
The chromatographic separation was completed in the isocratic mode.
The used column was USP-L8 (250 mm × 4.6 mm) of BDS type of 10
μm meters in the same mobile phase throughout the analysis by
using methanol and ultrapure water with a ratio of 7:93, respectively.
The flow rate was 1.0 mL/min. The mobile phase was filtered through
0.45 μm filter paper, and isocratic elution was performed. The
refractive index (RI) detector was used to analyze this sample. The
specific peak of enoxaparin sodium was observed at 5:56 min. The calculated
detection limit (LOD) was 0.351 ppm, and the calculated quantitation
limit was 1.063 ppm. In repeatability of precision, the average calculated
assay (%) was 100.85%, and the calculated RSD (%) was 0.01. In the
accuracy test, the RSD (%) was 0.50, and the mean recovery (%) was
100.35. The system’s suitability was within the limit. This
newly developed method is proposed according to ICH guidelines, and
rules and can be applied effectively for the exact estimation of enoxaparin
sodium in injection formulation. This newly developed methodology
is affordable in cost as long as less time is taken and the consumption
of samples is in smaller quantities for every investigation. In medicinal
chemistry, the USP (United States Pharmacopeia) and BP (British Pharmacopeia)
are directly involved in production as well as in quality testing.