Analysis of Chlorobutanol in Ophthalmie Ointments and Aqueous Solutions by Reverse-Phase High-Performance Liquid Chromatography

Assay of Desmopressin Acetate in Nasal Spray: Development of Validated Pre Column HPLC-Fluorescence Method

“…In the method reported in literature, 9 the DDAPV and chlorobutanol was eluted within 10min, but it had taken more than 30min for elution of BKC, when employed in the laboratory conditions. When, the HPLC conditions employed as mentioned in literature, 18 the elution of Chlorobutanol, DDAPV and BKC, the Chlorobutanol was eluted in column void and DDAPV was eluted at 1.86 min whereas, BKC was eluted within 10min. Therefore, in the next trial 0.1 %TFA with ACN in the ratio of 65:35 was used as mobile phase on a C18 stationary phase.…”

Analytical and Preformulation Characterization Studies of Human Papillomavirus Virus-Like Particles to Enable Quadrivalent Multi-Dose Vaccine Formulation Development

“…The competitive enzyme-linked immunosorbent assay (ELISA) method for AH-adsorbed VLPs was developed in-house, while the competitive ELISA for HPV16 VLPs in solution was adapted from Zhao et al, 38 as described in the Supplementary Methods. The reversed-phase ultra-high-performance liquid chromatography (RP-UHPLC) assay for monitoring preservative concentration and stability was adapted from Ng et al and Dunn et al 39,40 and is described in the Supplementary Methods. The experimental details for the microbial inhibition assay and the modified version of the EP assay are provided in the Supplementary Methods.…”

“…To evaluate the concentration and physical stability of the non-TH preservatives in the presence of vaccine components (e.g., AH-bound HPV VLPs), we implemented an RP-UHPLC method based on Ng et al and Dunn et al 39,40 A representative chromatogram shows almost baseline resolution for a mixture of the seven preservatives in a single run (Figure 5a). A short-term stability study was performed using preservative-containing placebo samples (see methods) to evaluate the stability-indicating nature of the method.…”

“…79 RP-HPLC has been commonly employed to monitor the stability of preservatives in various multi-dose formulations, including vaccines. 39,[80][81][82] We also utilized an RP-UHPLC method that could separate seven preservatives of interest, including BA, PH, 2-PE, MP, MC, CB, and PP, in a single run due to differences in the hydrophobicity of these preservatives. The method was suitable for AH-containing formulations since these preservatives did not interact with the AH (data not shown).…”

A critical review on the use of modern sophisticated hyphenated tools in the characterization of impurities and degradation products

“…Preference here shall also be given to stress testing of drug under solid state, which can unravel newer DPs, as reported for cefaclor [72] and clopidogrel bisulfate [120]. It has been observed that some researchers employ extreme stress conditions for the generation of DPs [130,131], which is justified and reasoned only in few cases. For example, in the report on structure elucidation of IMPs and DPs of fentanyl, Garg et al [131] conducted thermal heating at 350 • C, taking clue from a previously published paper on inhaling of the drug in a vaporization apparatus to produce a thermally generated aerosol that showed significant enhancement in bioavailability [132,133].…”