Development and Validation of Stability Indicating RP-LC Modus Operandi for Estimation of Palanosetron in Bulk and Formulations


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Volume :

10

Issue :

1

Abstract :

An isocratic reverse phase liquid chromatography (RP-LC) modus operandi has been stride and subsequently validated for the tenacity of Palonosetron in Bulk and its pharmaceutical formulation. Severance was clinch with a Symmetry RP-8 (Make: Waters Corporation; 75 mmx4.6 mm I.D; particle size 5 µm) Column and Prim.- Potassium phosphate monohydrate buffer (pH regulated to 3.0 with lessend orthophosphoric acid): acetonitrile (75:25) v/v as eluent at a flow rate of 0.8 mL/min. UV perception was execute at 210nm. The modus operandi is simple, rapid, and selective. The elucidate modus operandi of Palonosetron is linear over a range of 2.2 µg/mL to 13.6 µg/mL. The modus operandi precision for the tenacity of assay was below 1.0% RSD. The percentage restoration of active pharmaceutical ingredient (API) from dosage forms generation from 99.0 to 100.9%. The results proclaimed that the postulated modus operandi is suitable for the precise, accurate and rapid tenacity of Palonosetron in bulk and its dosage forms.

Keyword :

Palonosetron, RP-LC, Validation, Dosage form.
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