A combined qualitative and quantitative method development and validation of vancomycin hydrochloride injection formulation by HPLC and UV involving quality by design

Abstract

A selective, specific, precise, linear, accurate and robust analytical method was developed and validated for the assay of vancomycin HCl in vancomycin hydrochloride injection. Comparative UV spectrophotometric and reverse‐phase HPLC were used to develop the quantitative determination. Acetonitrile and pH 2.2 phosphate buffer in the ratio 20:80 v/v were used as the mobile phase, and a flow rate of 1.0 ml/min with a 20 min run time. The detection was carried out at 235 nm with a Nucleosil C18 (250 × 4.6 mm) 10 μm column, and the ambient column temperature was maintained. The method uses a 20 μl injection volume and diluent as a blank solution in this connection. The method was validated as per the current regulatory guidelines. The linearity of this method was found to be linear in the range of 50–150% of the working concentration, and the correlation coefficient was >0.999. The method’s accuracy was within the acceptable range, which was 98.1–101.5%. The method’s precision was within an acceptable range of about 0.32% RSD. The analytical solution was stable for up to 48 h at room temperature. The method’s robustness was proved by utilizing quality design tools. Stress studies demonstrated the method’s stability‐indicating nature.

Stability‐indicating method development and validation for quantitative estimation of organic impurities of the antidiabetic drug glipizide in drug substance and pharmaceutical dosage form using HPLC

“…The acid and alkali stress samples were neutralized with 5 m NaOH solution, and 5 m HCl solution, respectively. The oxidation sample solution was exposed to heat at 60°C for 3 min in a water bath to stop the chemical reaction (Gulshan et al, 2008; Jythesh, Koteswara Rao, et al, 2023; Mahesh et al, 2022; Narasimha et al, 2019; Nikita & Charmy, 2013; Sasikala et al, 2022).…”

Stability‐indicating method for quantification of potential genotoxic impurity and other organic impurities of chlorzoxazone using hyphenated techniques

“…Considering the sensitivity and toxicity of this impurity (its consumption of high levels will cause cancer), we have selected the RP-HPLC-MS/MS technique for the estimation of 2-amino-4-chlorophenol in ppm level (Figure 1) [19][20][21][22][23]. Both methods were developed and validated considering the International Council for Harmonization (ICH) requirements, which met its acceptance criteria and were found to be specific, linear, accurate, precise, and robust [24][25][26][27][28]. The results of the forced degradation study confirmed that the developed RP-HPLC-UV method is stabilityindicating, in addition to being specific and selective in the separation and quantitative determination of organicrelated impurities of chlorzoxazone drug substance and drug product [29,30].…”