New Validated RP-HPLC Method for Cisplatin and Topotecan in API and Vaccine Form and its Stress Studies
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HPLC, Cisplatin, Topotecan, Development, Validation
Abstract
We have developed a completely unique and reliable HPLC technique for simultaneous quantification of Cisplatin and Topotecan. A chromatographic detachment was attained on a XDB C18 column (150x4.6mm, 3.5 µ) using isocratic elution with a buffer containing buffer and acetonitrile with the proportion of 60:40 as a movable phase with a flow of 1 mL/min at room temperature and UV detection was carried out at 262 nm. Dissolve 1mL of triethylamine in 1 lt of HPLC grade water and filter through 0.45 µ filter paper. This solution was used as a buffer. 10 min run time was used to separate Cisplatin and Topotecan. The analysis was achieved within 15 min over honest linearity within the concentration range from 5-75 µg/mL of Cisplatin and 2-30 µg/mL of Topotecan. By injecting the standard six times, system suitability parameters were studied and the outcomes were under the acceptable limit. Precision and recovery study results were found to be within a suitable limit. By using the above technique, the assay of the marketed formulation was performed and found to be within the limit. Degradation studies were carried out on Cisplatin and Topotecan, with a purity threshold greater than the purity angle in all conditions and within the acceptable range. The above-mentioned technique was validated according to ICH guidelines.
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