Characterization of Impurities of Glipizide Tablets in Different Manufactures by Liquid Chromatography-Mass Spectrometry and Analysis the Correlation between the Process of Recrystallization and Impurities

Chen, Dejun; Yu, Miao; Zhang, Dongmei; Wang, Song; Liu, Wenkun; Wang, Weijian; Wang, Sicen

doi:10.2139/ssrn.4092483

Cited by 1 publication

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“…The available HPLC-UV method (Sakshi & Gulshan., 2011) not covered the glipizide methyl carbamate impurity was mentioned in the United States Pharmacopeia (USP) monograph and observed the poor baseline and impurities are not separated clearly from the blank pattern. Another Liquid chromatography-mass spectrometry method (Dejun et al, 2022) did not cover glipizide-related compound-B impurity. These methods are developed for estimating glipizide impurities by using diluted glipizide solutions as standard.…”

Section: Introductionmentioning

confidence: 99%

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

Nagulancha,

Vandavasi

2023

Biomedical Chromatography

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Glipizide is an antidiabetic drug used for the treatment of type 2 diabetes. A simple, reliable and robust reverse‐phase liquid chromatographic method (RP‐HPLC) was developed and validated as per International Conference on Harmonization Q2(R1) for estimating the impurities of glipizide in pharmaceutical formulations. The chromatographic separation was carried out on a Phenomenex Luna C18 (2), 250 × 4.6 mm, 5 μm with a binary solvent delivery system [MP‐A, a homogenous mixture of water and acetonitrile in a ratio of 90:10 (v/v) and 1 ml of orthophosphoric acid; and MP‐B, a homogenous mixture of water and acetonitrile in a ratio of 10:90 (v/v) and 1 ml of orthophosphoric acid] with a detection wavelength of 225 nm, a column temperature of 30°C, a flow rate of 1.5 ml/min, and an injection volume of 20 μl. All process, degradant and unknown impurities were separated well with a resolution >2.2 and were estimated accurately without any interference. The recovered values and regression values were 98.7–100.5% and R2 > 0.9999, respectively. The recovery and linearity studies covered the quantitation limit to 150% of the specification limit. The stability‐indicating properties of the developed RP‐HPLC method was assessed from the forced degradation studies. The developed method was successfully applied for real‐time sample analysis of the glipizide dosage form.

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Section: Introductionmentioning

confidence: 99%