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- Title
DEVELOPMENT AND VALIDATION OF HPLC METHOD FOR ESTIMATION OF TEMSIROLIMUS IN PARENTERAL DOSAGE FORM.
- Authors
Vasani, M. P.; Doshi, D. B.; Rana, P. J.; Patel, D. V.
- Abstract
Temsirolimus is a derivative and prodrug of sirolimus,used in treatment of renal cell carcinoma. A simple, precise, rapid and accurate reverse phase high performance liquid chromatography method was successfully developed and validated for estimation of temsirolimus in parenteral dosage form. Chromatographic separation was achieved on a phenomenexSynergi™ 4μm Fusion- RP 80Å (250 × 4.6 mm, 4μm)using mobile phase containing component A and component B (25:75), where component A is 0.1%v/v formic acid : THF (90:10) and component B is methanol at the flow rate 1.0 mL/min with UV detection at 277 nm. The column was kept at 50°C. A linear response was observed in the range of 50-120 μg/mL with correlation co-efficient of 0.9998. The mean percent recoveries of temsirolimusin parenteral dosage form were found to be in the range of 98.61-99.35 %. The intraday and inter-day precision were found to be within limits. The proposed method has adequate specificity, sensitivity and reproducibility for quality control assay of temsirolimusin parenteral dosage form without any interference from excipients.
- Subjects
HIGH performance liquid chromatography; DOSAGE forms of drugs; CANCER treatment; RENAL cell carcinoma; FORMIC acid; RAPAMYCIN
- Publication
Pharma Science Monitor, 2017, Vol 8, Issue 2, p165
- ISSN
0976-9242
- Publication type
Article