World Journal of
Pharmaceutical and Life Sciences

RP-HPLC ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR QUAN TITATIVE ESTIMATION OF ITOPRIDE HYDROCHLORIDE IN SOLID ORAL FOR MULATIONS

Dhanush Ram Turkane*

ABSTRACT

The present study was aimed at the development and validation of a simple, rapid, precise, and stability-indicating
reverse-phase high-performance liquid chromatographic (RP-HPLC) method for the quantitative estimation of Ito
pride Hydrochloride in tablet dosage forms. Chromatographic separation was achieved using a C18 column (250
mm × 4.6 mm, 5 µm) with a mobile phase consisting of potassium dihydrogen phosphate buffer and methanol
(60:40, v/v) at a flow rate of 1.0 mL/min. Detection was carried out at 220 nm using a UV detector. The retention
time of Itopride Hydrochloride was found to be approximately 5.84 minutes, enabling rapid analysis. The method
was validated according to ICH Q2(R1) guidelines for specificity, linearity, accuracy, precision, robustness, sensi
tivity, and system suitability. The method exhibited excellent linearity over the concentration range of 50–150%,
with a correlation coefficient (R²) of 0.9998. Accuracy studies showed mean recovery of 100.24%, while precision
studies demonstrated low %RSD values below 0.5%, indicating excellent repeatability and reproducibility. The
limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.32 µg/mL and 1.08 µg/mL, respec
tively, confirming the sensitivity of the method. Robustness studies revealed that minor deliberate changes in
chromatographic conditions did not significantly affect analytical performance. Forced degradation studies under
acidic, alkaline, oxidative, and thermal stress conditions demonstrated that the method could effectively separate
degradation products from the main drug peak, confirming its stability-indicating nature. The developed RP-HPLC
method was found to be accurate, precise, robust, sensitive, and suitable for routine quality control analysis and
stability studies of Itopride Hydrochloride in pharmaceutical dosage forms.

[Full Text Article]   [Download Certificate]