Novel Stability Indicating RP-HPLC Method for The Estimation of Pinaverium Bromide in Tablet Formulation: Assay Development and Validation

Abstract

A selective RP-HPLC method has been developed for the estimation of pinaverium bromide
(PB) in tablet dosage form. A Phenomenox C18 (250 x 4.6 mm i.d., particle size 5 µm) column
with ammonium acetate buffer (pH 3.0) and acetonitrile (20:80) was employed as the mobile
phase. The flow rate of 1 mL/min was utilized employing 214 nm as detector range where
the drug eluted at 5.067 min. The method was validated further for linearity, accuracy,
precision, and robustness according to the ICH guidelines. Forced degradation studies were
performed under neutral, acidic, alkaline conditions along with thermal, photolysis and
oxidative stress conditions, where the drug exhibited degradation and various peaks were
monitored. The method was found to be linear over the range concentration range of 12.5-
75.0 μg/mL (r2 values of 0.999), accurate (recovery of about 100.22% with % RSD of < 2%),
highly precise (% RSD of < 2% in both intra-day and inter-day study), and robust enough
to deliver accurate results when the chromatographic conditions were altered deliberately.
No interference of additives/excipients was encountered while developing this method.
Highest degradation was observed under oxidative stress condition. This method will help
in the quantitative determination of PB and its degraded products.