Development and validation of a RP-HPLC method for quality control of oxantel pamoate, pyrantel pamoat and praziquantel in tablets

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In the present study, simple, rapid and precise HPLC methods
were developed which would be useful for quality control of
pharmaceutical dosage forms containing praziquantel (PRZ),
pyrantel pamoate (PPA) and oxantel pamoate (OPA). The first
method (M1) was developed for the analysis of PRZ; separation
was achieved using a reversed–phase column (4.6 x 150 mm,
5 μm) C18, a mobile phase comprising ACN:MeOH:20 mM
phosphate buffer (0.2 % TEA, pH 4.5) (50:10:40, v/v/v) and
UV detection at 210 nm. PPA and OPA were analysed
simultaneously using a separate method (M2) by employing
the same column and flow rate. In accordance with the second
method (M2), detection wavelength was set at 295 nm and a
mobile phase of ACN:MeOH:20 mM phosphate buffer (0.2 %
TEA, pH 4.5) (12:3:85, v/v/v) was used. Benazepril
hydrochloride (BZP) and paracetamol (PAR) were used as
internal standards (IS) of the methods M1 and M2, respectively.
Both methods were validated based on the parameters such as
specifity, linearity, precision, accuracy, limit of detection
(LOD) and limit of quantitation (LOQ) besides system
suitability tests. Forced degradation studies were performed to
indicate specifity of the proposed methods. The methods were
found linear over the concentration ranges of 0.5–7.5 μg/mL,
1–15 μg/mL and 2–40 μg/mL for PRZ, PPA and OPA,
respectively. Correlation coefficients (r) of the regression
equations were greater than 0.999 in all cases. The precision of
the methods was demonstrated using intra- and inter-day assay
RSD values which were less than 1% in all instances. Accuracy
of the proposed methods was tested on placebo tablets spiked
with known amounts of actives. Resulting recoveries of assays
were in the range of 99.9–101.1 % whereas, those from
commercial tablets were 99.4–100.8 %.
Keywords: Oxantel pamoate, Pyrantel pamoate, Praziquantel,
HPLC, analytical method validation.


Oxantel pamoate, Pyrantel pamoate, Praziquantel, HPLC, analytical method validation

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