Validated RP-HPLC analysis of irinotecan HCl in the bulk material and in pharmaceutical formulations

• Autorzy: Shende, P. , Gaud, R.
• Języki publikacji: EN

Abstrakty

EN

An isocratic reversed-phase high-performance liquid chromatographic (RPHPLC) method for analysis of irinotecan HCl has been developed and validated. Separation was achieved on a C 18 column with potassium dihydrogen phosphate buffer (pH adjusted to 3.5 with orthophosphoric acid)-acetonitrile-methanol 55:25:20 ( v/v ) as mobile phase at a flow rate of 1.0 mL min ^-1. UV detection was performed at 254 nm. The method is simple, sensitive, rapid, and selective, and linear over the range 30-70 µg mL ^-1 for assay of irinotecan HCl. The precision of the assay method was below 1.0% RSD. Mean recovery was in the range 98.0-102.0%. Recovery of the active pharmaceutical ingredient from dosage forms ranged from 99.0 to 101.0. The method is useful for quality control in bulk manufacture and of the pharmaceutical formulation.

Słowa kluczowe

EN

irinotecan HCl; RP-HPLC analysis; method validation

• Czasopismo: Acta Chromatographica
• Rocznik: 2009
• Tom: Vol. 21, no. 1
• Strony: 71-82
• Opis fizyczny: Bibliogr. 11 poz., rys., tab.

Twórcy

autor

Shende, P.

autor

Gaud, R.

• NMIMS University School of Pharmacy and Technology Management V.L. Mehta Road, Vile Parle (W) Mumbai 400056 India,

Bibliografia

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