A review on analytical method validation and its regulatory perspectives

Lal, Basant; Kapoor, Devesh; Jaimini, Manish

doi:10.22270/jddt.v9i2.2403

Cited by 9 publications

(3 citation statements)

References 0 publications

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“…Method validation is defined as (ICH) establishing documented evidence that provides a high degree of assurance that a specific activity will consistently produce a desired result or product that meets its predetermined specifications and quality characteristics [3]. A method's validation is the process by which a method is tested by the developer or user for its dependability, accuracy, and precision in serving its intended purpose.…”

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

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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.

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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

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“…Validation is important and plays major role to choose the standard, reliability, and consistency of analytical results, that is associated with integral part of any sensible analytical practice. 9 Validation of analytical methods is additionally needed by most regulatory authorities and quality standards that impact laboratories. Dosage forms developed with more than one drug, generally said as combination products, are meant to satisfy patients, and would like analytical method development and validation by combining the therapeutic effects of two or more drugs (API) in one product.…”

Section: Fig 1: (A) Solriamfetol (B) Modafinilmentioning

confidence: 99%

A Novel Analytical Method for the Estimation of Solriamfetol in Plasma Samples by Lc-Ms/Ms

Perina.Ratnakumari

Kannappan

Premkumar³

2022

Int J Life Sci Pharm Res

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Solriamfetol is a selective dopamine and norepinephrine reuptake inhibitor with wake‐promoting effects. The aim of the present study is to develop a rapid, sensitive and reliable method for the estimation of Solriamfetol in plasma samples using LC-MS. In the present investigation, a rapid, specific, selective and novel method has been optimized for evaluation of solriamfetol in in plasma using modafinil as an internal standard and identification of degradants by LC-MS/MS. The solriamfetol and internal standard were extracted from plasma in a single step using acetonitrile. The principle analytes were eluted with the conditions of mobile phase having the 5mM ammonium format in methanol: 50% Methanol in acetonitrile (90:10%, v/v). The Chromatographic column used is Xterra MS C18, 3.5µ.m, 1mmX150mm analytical column with the 0.5 ml/min flow rate. The detector is CEM array detector. The retention times of solriamfetol and modafinil were 1.50min-1.51min with a total run time of 3 min. The curve indicates correlation coefficient (r2) for modafinil was superior by having the value 1.000 with linear range of 5ng/ml to 500ng/ml. The correlation coefficient (r2) for solriamfetol was found to be 0.999. The LOQ and LOD for the solriamfetol was 33.70pg/ml and 11.12pg/ml respectively The developed method was validated by evaluating system suitability, selectivity, sensitivity, linearity, precision, accuracy, ruggedness and stability in conformity with the guidelines of the United States Food and Drug Administration (US-FDA). The results of validation parameters were found to be within the acceptance limits. Hence, the developed and validated method can be utilized for the routine determination of solriamfetol in plasma samples.

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“…Hence, there is emerging pharmaceutical branch called 'pharmaceutical analysis' was born to deal with separation, quantification & additive identification of synthetic as well as natural substances with one or more compounds [1]. It is primary task to estimate analysis of pharmaceutical product by developing the analytical method but, with developing the analytical method it is important to validate that particular method, this method can be optimized & validate by taking the trial runs on the specific chromatographic instruments [2].…”

Section: Introductionmentioning

confidence: 99%

Bioanalytical method development and validation of folic acid from rat plasma using reverse phase high performance liquid chromatography

Chaudhary¹,

Shrangare²,

BHUSARI³

2023

jrp

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A simple, rapid and sensitive Reverse phase High performance liquid chromatography (RP-HPLC) bioanalytical method was developed for the determination of folic acid in rat plasma using methylparaben as an internal standard. The developed method involves simple sample preparations and had total run time of 20 min using RP-HPLC. Chromatographic separation was performed on Inertsil ODS C18 column (4.6×100 mm, 5µm) using isocratic elusion system of potassium phosphate buffer (pH 7): Methanol (75:25 v/v) as mobile phase. Mobile phase flow rate was kept at 1ml/min with column temperature of 40°Cat pressure 88-90 bars. The maximum wavelength used for the detection of folic acid was 283nm. The retention time of folic acid and methylparaben was found to be 6.4 & 13.2 respectively. The method was tested for linearity range of 2 to 12 µg/ml. Developed method was validated for system suitability, selectivity, linearity & range, accuracy, precision, robustness, LOD & LOQ, and stability according to the international regulatory guidelines. Minimum sample preparation and short run time make the method valuable for performing the analysis. Developed method was successfully applied in the determination of folic acid levels In-vivo in rat plasma after oral administration.

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A review on analytical method validation and its regulatory perspectives

Cited by 9 publications

References 0 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

A Novel Analytical Method for the Estimation of Solriamfetol in Plasma Samples by Lc-Ms/Ms

Bioanalytical method development and validation of folic acid from rat plasma using reverse phase high performance liquid chromatography

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