Quality-by-design driven analytical method (AQbD) development and validation of HPLC–UV technique to quantify rivastigmine hydrogen tartrate in lipidic nanocarriers: Forced degradation, and assessment of drug content and in vitro release studies

Salwa, -; Kumar, Lalit

doi:10.1016/j.microc.2023.108944

Cited by 15 publications

(1 citation statement)

References 23 publications

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“…The purpose of this work was to establish and verify as user friendly, fast, sensitive, selective, and precise HPLC method for the quanti cation of ERT which has been incorporated in MSNs. Developing a method takes a lot of effort and often requires the "one-factor-at-a-time" (OFAT) method, which modi es one factor at a time until a workable solution is found [14]. The OFAT approach might suggest the appropriate methodology, yet, it just provides a super cial understanding of the method's repeatability and potential.…”

Section: Figure 1 Pictorial Representation Of Erastinmentioning

confidence: 99%

Box-Behnken design-based development of eco-friendly RP-HPLC analytical method for the quantification of erastin from the mesoporous silica nanoparticles

Gupta,

Moorkoth

et al. 2024

Preprint

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The current work aims to optimize, stablish, validate a high-performance liquid chromatography (HPLC) method that possesses sufficient sensitivity and specificity to measure erastin (ERT) in mesoporous silica nanoparticles. The HPLC method was optimized using Design of Experiments (DoE) technique. The Box-Behnken design (BBD) was used and buffer ratio, injection volume, buffer pH, and flow rate were used as the independent factors. The dependent variables were retention time (Rt) of ERT, peak area of ERT, and tailing factor (Tf) of ERT. The optimized chromatographic condition were: buffer ration 80%, buffer pH 3.8 and flow rate 0.9 mL/min, and injection volume 8 µL. The established HPLC method was validated as per ICH Q2 (R1) recommendations. The established method showed the good linearity (R2 = 0.9991) having a range of 12–500 ng/mL and LOD and LOQ was 2.71 ng and 6.25 ng, respectively. The mesoporous silica nanoparticle (MSN) matrix did not affect the specificity of our validated RP-HPLC method of analysis for ERT. Analysing the formulation's surface morphology helped with the confirmation of the synthesized MSNs. The proposed RP-HPLC method was effectively used to calculated the medication loaded in the MSNs as well as to measure the amount of ERT entrapped. The % EE for ERT in MSNs was found to be 76.07% and % DL for ERT in MSNs was found to be 14%, respectively. The established HPLC method was found ecofriendly as per the AGREE analysis.

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Section: Figure 1 Pictorial Representation Of Erastinmentioning

confidence: 99%