RP-HPLC ESTIMATION OF METHOTREXATE AND TRETINOIN IN BULK AND PHARMACEUTICAL DOSAGE FORMS.
Abstract
A simple, sensitive and selective RP-HPLC method with for the estimation of Methotrexate and tretinoin in pharmaceutical formulation and in spiked plasma developed and validate in present work. Chromatographic separation of drug is performed with a 250X4.6 mm, 5µm diameter particles RP C-18 column and the mobile phase consisted of a mixture of ACN: Buffer (85:15, v/v). Isocratic elution at a flow rate of 1 ml/min with UV detection at 340 nm at ambient temperature is used in this method. The proposed RP-HPLC method is successfully applied for the determination of MTX and tretinoin in pharmaceutical preparation and spiked plasma samples. The validation studies are carried out and it’s fulfilling ICH requirements. The method is found to be specific, linear, precise (including both intra- and inter- day precision), accurate and robust. This proposed method may represent a valuable aid in the laboratory monitoring of the toxicity of anticancer chemotherapy.
KEYWORDS: RP-HPLC, Leukemia, Methotrexate (MTX) and Tretinoin, Linearity and Calibration curve, malignant disorder