Stability studies HPLC analysis

Tan X, Meltzer N, Lindenbaum S. Solid-state stability studies of 13-cA-retinoic acid and all-trans-retinoic acid using microcalorimetry and HPLC analysis. Pharm Res 1992 9(9) 1203-1208. 

Castro et al. [64] reported a comparison between derivative spectro-photometric and liquid chromatographic methods for the determination of omeprazole in aqueous solutions during stability studies. The first derivative procedure was based on the linear relationship between the omeprazole concentration and the first derivative amplitude at 313 nm. The first derivative spectra were developed between 200 and 400 nm (A/ = 8). This method was validated and compared with the official HPLC method of the USP. It showed good linearity in the range of concentration studied (10—30 /ig/ ml), precision (repeatability and interday reproducibility), recovery, and specificity in stability studies. It also seemed to be 2.59 times more sensitive than the HPLC method. These results allowed to consider this procedure as useful for rapid analysis of omeprazole in stability studies since there was no interference with its decomposition products. 

S. Wanwimolruk, Rapid HPLC analysis and stability study of hydrocortisone-17-butyrate in cream preparations, Pharm. Res., 8 547 (1991). 

In order to identify any excipient- and packaging-related impurities in the formulation, placebo cores and hlm-coated placebos, were prepared using the same excipients as in the active tablets. The placebo cores and film-coated placebos, as well as active cores and hlm-coated active tablets were set up on a stability study in high density polyethylene (HDPE) bottles with and without desiccant and in foil-foil blisters. At the designated time intervals, the tablets were tested for purity by gradient HPLC analysis. 

Prior to the incorporation of protected Cys residue into polymers, the stability of the Npys group was studied in the presence of pentafluorophenol. This was caused by the formation of this compound as byproduct during the reaction between Boc-Cys(Npys)-OPfp and the a-amino groups of the N-terminal amino acids of branched polypeptides. In a model experiment, Boc-Cys(Npys)-OH was kept in DMF-water (9 1, v/v) mixture in the absence or presence of pentafluorophenol. Based on HPLC analysis we found that the Npys group is stable under these conditions. 

Zhang et al. [43] developed and validated a stability indicating HPLC method for the determination of lornoxicam in pharmaceutical formulation. The isocratic procedure was performed in Shimadzu ODS (4.6 mm x 15 cm, 5 pm) column maintained at 25 °C. The mobile phase was degassed mixture of sodium acetate (0.05 mol/L, pH 5.8) and methanol (55 45). The flow rate was 1 ml/min and detection at 290 nm. Selectivity, specificity, linearity, precision, accuracy, and robustness were evaluated to validate the analytical method. Forced degradation studies were performed to provide an indication of the stability-indicating capacity. The stability indicating method for lornoxicam in the injectable dosage was developed and validated. The method can be considered for routine analysis and quality control of lornoxicam in injectable formulation. 

The results of the serum stability study are depicted in Fig. 13.4. During the 6 h incubation in human serum, the radiochemical analysis showed high labelling yield (>98%) for Y-DO IATATF . as assessed by HPLC, TLC and SepPak column. The Lu-DOTATATE preparation was also very stable (>98% radiochemical purity) when incubated in human serum up to 24 h. The... 

Example 7.3 In product stability studies, it is known that certain products are highly sensitive to ultraviolet radiation. In a full-spectrum light study, a clear-glass configuration of product packaging was subjected to constant light for seven months to determine the effects. At the end of each month, HPLC analysis was conducted oti two samples to detect any degradation of the product, in terms of percent potency. 

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