Stability indicating reversed‐phase‐high‐performance liquid chromatography method development and validation for pyridostigmine bromide and sodium benzoate in oral solution

Abstract

The present study focuses on the development of a simple, rapid, specific, and stability‐indicating HPLC method for the simultaneous analysis of pyridostigmine bromide (PGB) and sodium benzoate (SBN) in oral liquid dosage forms. Analytical techniques should enhance sensitivity and specificity for the estimation of pharmaceutical drug products. Stress studies were conducted under various International Conference on Harmonization (ICH) conditions for evaluation. The further optimized HPLC method was validated in accordance with the current ICH guidelines. Chromatographic separation was accomplished using a mobile phase consisting of a 950:50 v/v ratio of perchloric acid buffer and acetonitrile as mobile phase‐A, and 100% acetonitrile as mobile phase‐B. The flow rate is 1.0 mL/min, and the injection volume is 20 μL. Detection of components was carried out at 220 nm for PGB and 228 nm for SBN. The validated HPLC method demonstrated high specificity, with linearity ranging between 24 and 72 μg/mL for PGB and 5.2–15.6 μg/mL for SBN. The correlation coefficient for both drugs exceeded 0.999. The method demonstrated high accuracy, exceeding 97%. In stress studies, PGB was found to be sensitive to alkaline stress conditions. The results reveal the successful applicability of the current method for the estimation of PGB and SBN in its marketed formulation, which can be reasonably inferred to assess other formulation systems.

Reversed-Phase-HPLC Assay Method for Simultaneous Estimation of Sorbitol, Sodium Lactate, and Sodium Chlorides in Pharmaceutical Formulations and Drug Solution for Infusion

“…However, there is a notable absence of articles or studies published on the simultaneous estimation of all three components using HPLC with a shorter run time. Additionally, the developed method underwent validation following established guidelines, and the method validation sections in the current research refer to articles [21]- [26]. It's worth noting that this marks the first-ever development of an RP-HPLC method for quantifying the assay of sorbitol, sodium lactate, and sodium chloride in pharmaceutical formulations and infusion solutions through HPLC.…”

Validation of a high‐performance liquid chromatography method for determining lysophosphatidylcholine content in bovine pulmonary surfactant medication

“…Finally, owing to the importance of method validation (Beg et al, 2016;Brown, 2024;Chen et al, 2024;Chintala, 2024;Dar et al, 2022;Davis et al, 2024;Heudi & Winter, 2024;Hussien, 2014;Rajadhyaksha & Londhe, 2024;Sharma et al, 2012;Xue et al, 2012), the method underwent comprehensive validation for eight parameters. Importantly, the execution of this analytical method does not depend on any state-of-the-art equipment.…”