HPLC METHOD DEVELOPMENT AND VALIDATION FOR TESTOSTERONE CIPIONATE IN BULK DRUG AND OIL-BASED INJECTABLES
Rakesh Kumar Gupta* and Anurag
Isocratic liquid chromatographic method for the determination of testosterone cipionate (TC) in bulk drug and oil-based injectables has been developed and validated. Mobile phase methanol: water (90:10) was used for Testosterone Cipionate. For this method, a bonded-silica Luna 5μ C8 (2)100A (250 mm × 4.6 mm, C 8, 5 micron.) (250C) column, a flow-rate of 1.2 ml min−1 and UV absorbance detection at 240 nm were used and separations up to base line were achieved. Prior to HPLC analysis, different dilution of bulk drug and sample preparation was required from oil-based injectables using the surfactant sodium dodecyl sulphate.
Keywords: HPLC; Validation; Testosterone cipionate; Oil-based injectables.
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