Geetha Bhavani Koduri
1,2, Hari Babu Bollikolla
3, Ramachandran Dittakavi
3*, Srinivasu Navuluri
2*1 JMJ College for Womens, Tenali, Andhra Pradesh, India.
2 Department of Science and Humanities, Vignan University, Vadlamudi, A.P., India
3 Department of Chemistry, Acharya Nagarjuna University, Nagarjuna Nagar, Guntur. A.P., India.
Abstract
Background: Pimavanserin, an antipsychotic agent, is used to treat
patients suffering with Parkinson's disease. Till now no stability indicating
reverse phase HPLC method was reported for the quantification of pimavanserin
in bulk and tablet dosage form. Hence in the present study, a new sensitive,
precise and accurate stability indicating reverse phase HPLC method with
photodiode array detector has been developed for the quantification of
pimavanserin in bulk and tablet dosage form.
Methods: Separation
and analysis of pimavanserin was achieved on Kromasil C18 (5 µm, 250 mm × 4.6
mm) column using 0.1M NaH2PO4, methanol and acetonitrile
in ratio of 55:30:15 (v/v/v) as mobile phase at 25°C. The flow rate was 1.0
ml/min. The effluents were monitored with detector set at 239 nm. The method
validation was done with regard to the guidelines by the International Conference on Harmonization.
Pimavanserin was subjected to acid, alkali and neutral hydrolysis, hydrogen
peroxide oxidation, thermal degradation, and photo (sunlight) degradation.
Results: Linear
relationship was obtained between the concentration of drug and peak area
response in the range of 4.25-34.0 µg/ml. The limits of detection and
quantitation were found to be 0.027 µg/ml and 0.089 µg/ml, respectively. All
the validation characteristics were within the acceptance criteria. The peaks
of degradation products were well resolved from the pimavanserin peak.
Conclusion: The
developed and validated method is able to quantify the pimavanserin in the
presence of degradation products.