A Novel RP – HPLC Analytical Method Development and Validation of Fulvestrant Injection as per ICH Guidelines

Ghosh, Somsubhra; Mandal, Sudip Kumar; Roy, Tathagata; Ravikumar, B

doi:10.21608/ejchem.2021.56503.3215

Cited by 4 publications

(5 citation statements)

References 9 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…All parameters that are normally clarified during the validation process are accuracy, precision, specificity, linearity, range, and robustness. A validation report that includes all of the experimental conditions as well as all of the statistics should be created [4].…”

Section: Analytical Methods Validationmentioning

confidence: 99%

Analytical Method Validation of Gliclazide Related Substances by High Performance Liquid Chromatography Method

SABHYATHA

BABU

2022

Int J Curr Pharm Sci

View full text Add to dashboard Cite

Objective: The present study was undertaken with the objective of method validation of a rapid, simple, cost-effective HPLC method for the determination of related substances of Gliclazide. Methods: A simple, rapid, and specific method for analysis of gliclazide by a sensitive high-performance liquid chromatographic method is described. Validation of the method is carried out by USP and ICH guidelines. The method was validated for parameters like accuracy, precision, linearity, specificity, robustness, and system suitability. These proposed methods are suitable for the determination of title drugs in quality control laboratories in the pharmaceutical industries. Results: The mobile phase used for the chromatographic runs consisted of (450 ml) of acetonitrile and (550 ml) of water. The separation was achieved on the LiChroCART Supersher RP-8 column, (250 mm × 4.0 mm, 5 µm), using isocratic mode. Drug peaks were well separated and were detected by a UV detector at 235 nm, the method was linear at the concentration range. Gliclazide limit of detection (LOD) and limit of quantification (LOQ) was 0.003 and 0.01 while LOD and LOQ for Impurity-F were 0.003 and 0.01 respectively. Conclusion: The presented validated method is rapid, economic, simple, accurate, sensitive, robust, specific, and linear. It can be used for routine analysis of gliclazide.

show abstract

Section: Analytical Methods Validationmentioning

confidence: 99%

Analytical Method Validation of Gliclazide Related Substances by High Performance Liquid Chromatography Method

SABHYATHA

BABU

2022

Int J Curr Pharm Sci

View full text Add to dashboard Cite

show abstract

“…The ICH guidelines that are applicable to stress degradation studies are as follow; ICHQ1A:-New Drug Substances and Products Stability Testing, ICHQ1B:-Photo stability Testing of New Drug Substances and Products, ICHQ2B:-Validation of Analytical Procedures: Methodology. [2,4] The sample was also treated with described following Acid Hydrolysis, Alkaline Hydrolysis, Oxidation Degradation, Thermal Degradation and Photolytic Degradation conditions. 20 μL of the resulting solutions were injected into the HPLC system and the chromatograms were recorded.…”

Section: Regulatory Guidelines: Stress Degradation Studymentioning

confidence: 99%

“…Gliclazide inhibits SGLT, thereby aiding in better glycemic control for individuals with T2DM. [1,2,3,4,5]…”

Section: Introductionmentioning

confidence: 99%

Analytical Method Development and Optimization on High Performance Liquid Chromatography for Related Substances Test of Gliclazide Drug as Active Pharmaceutical Ingredient

Patidar,

Tiwari,

Nagle

2024

IJPSM

View full text Add to dashboard Cite

Diabetes mellitus, particularly Type 2 Diabetes Mellitus (T2DM), presents a significant global health challenge, necessitating continuous advancements in therapeutic strategies. Gliclazide, an oral selective inhibitor of sodium glucose co-transporter-2 (SGLT2), has emerged as a promising agent for managing T2DM by facilitating urinary glucose excretion and reducing plasma glucose levels. However, ensuring the quality and efficacy of pharmaceutical formulations remains crucial for regulatory approval and clinical effectiveness. In this study, we present the development of an improved stability-indicating Reverse Phase-High Performance Liquid Chromatography (RP-HPLC) method for the precise quantification of Gliclazide. The novel analytical method employs 0.1% Potassium Phosphate in water 0.1% Potassium Phosphate in methanol (MeOH) as the mobile phase, demonstrating enhanced sensitivity, cost-effectiveness, and reduced reliance on organic chemicals. Through rigorous validation following International Conference on Harmonisation (ICH) guidelines, the developed method exhibited superior performance in terms of retention times compared to existing methodologies. The proposed analytical approach holds promise for routine analysis of Gliclazide in both bulk and tablet formulations, offering a valuable tool for pharmaceutical quality control and clinical research in the management of T2DM.

show abstract

“…In comparison to the Linear Sweep Voltammetric Method, Stability Indicating HPLC Method for the Determination of Fulvestrant in Pharmaceutical Formulation [2], method was published with a 20% organic solvent and a 5-minute run duration, but the co-solvents could not be separated. Guidelines [4], method was published with 70 minutes run time and also not discussed about co-solvents. The 70-minute run time approach is not suited for routine testing of quality control samples for assay quantification.…”

Section: Introductionmentioning

confidence: 99%

A Novel RP-HPLC Method for Estimating Fulvestrant, Benzoyl Alcohol, and Benzyl Benzoate in Injection Formulation

Nekkalapudi¹,

Veldi²,

Pippalla³

2022

AJAC

View full text Add to dashboard Cite

For the quantitative determination of Fulvestrant, Benzyl alcohol, and Benzyl benzoate in Fulvestrant injection, an original RP-HPLC approach was developed. The gradient method was developed using HPLC and a Phenomenex Luna C8, 150 × 4.6 mm, i.d 3.0 µm particle size column with a gradient programme of mobile phases A and B. With a flow rate of 1.5 mL/minute, injection volume of 10 µL, and column temperature of 35˚C, UV wavelength detection at 254 nm for Benzyl alcohol and Benzoyl Benzoate and 280 nm for Fulvestrant, mobile phase-A consists of DI water and mobile phase-B consists of Acetonitrile. The current study describes a single HPLC method for developing a Fulvestrant (Active), Benzyl alcohol (Co-solvent), and Benzyl Benzoate (Co-solvent) assay for Fulvestrant injection. The assay method was determined to be suitable for quantifying three components in the pharmaceutical product and was verified according to ICH guidelines.

show abstract

A Novel RP – HPLC Analytical Method Development and Validation of Fulvestrant Injection as per ICH Guidelines

Cited by 4 publications

References 9 publications

Analytical Method Validation of Gliclazide Related Substances by High Performance Liquid Chromatography Method

Analytical Method Validation of Gliclazide Related Substances by High Performance Liquid Chromatography Method

Analytical Method Development and Optimization on High Performance Liquid Chromatography for Related Substances Test of Gliclazide Drug as Active Pharmaceutical Ingredient

A Novel RP-HPLC Method for Estimating Fulvestrant, Benzoyl Alcohol, and Benzyl Benzoate in Injection Formulation

Contact Info

Product

Resources

About