For the proposed procedure, linearity (r(2) = 0.9956 +/- 0.0015), limit of quantification (28.35 ng spot(-1)), limit of detection (9.41 ng spot(-1)), recovery (97.06-99.56%), and precision (< or = 1.86) were found to be satisfactory. Compact spots appeared at R(f) = 0.34 +/- 0.02. The densitometric analysis was carried out at 366 nm wavelength. The separation was achieved on TLC aluminum plates precoated with silica gel 60F-254 using chloroform-methanol (9.0:1.0 v/v) as mobile phase. These inferences seemed appropriate regarding the number of preparations to be assayed.Ī stability-indicating high-performance thin-layer chromatographic (HPTLC) method has been developed for the determination of terbutaline sulfate (TBS) as a bulk drug and in pharmaceutical formulations (submicronized dry powder inhalers). ![]() ![]() Considering their values and the concentration ranges (from 100 to 500 mg/L for HPTLC and from 0.1 to 1 mg/L for HPLC), it was decided to perform analysis using HPTLC for irinotecan preparations and HPLC for topotecan preparations. Coefficients of variation of repeatability (CVr) and intermediate precision (CVi) were determined for both methods. A calibration curve was plotted for each molecule and validated by three quality controls (high, medium and low). The chromatographic conditions that were chosen allowed identification of each drug through their rate of flow (Rf), 0.10 and 0.35, or their retention time (tR), 2 and 7 min for topotecan and irinotecan, respectively. Those two techniques made identity, purity and quantitation assays possible. ![]() Due to the difference of concentration between batches containing irinotecan or topotecan, HPLC and HPTLC both combined with fluorescence detection were investigated. irinotecan (CPT-11) and topotecan (TPT)) as part of protocols in Institut Gustave Roussy (IGR) has led to develop an efficient analytical method that could assess an increasing number of samples with high throughput, good specificity and practicality. The common use of camptothecin derivatives (i.e. In order to achieve the analytical assessment of the manufactured batches of chemotherapy preparations, post-production quality control has been developed.
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