High Performance Liquid Chromatography-A Validation View

Desai, Punam S.; Chavan, Rajeshwar V.; Amane, Nikita B.; Shete, Sanmati D.; Dhole, Archana R.

doi:10.5958/2231-5675.2019.00040.1

Cited by 8 publications

(3 citation statements)

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“…International Council for Harmonisation (ICH) (Q2-R1) guidelines are available for validating an analytical method. It assures a great impact on quality assurance and cost reduction [33,34] . Validation is required in the situations when the process is totally new, while installing and using new equipment, any process or piece of equipment that is subject to changes in usage as a result of altered conditions [29,35] and when process in which the test of the end product is not good, gives an indicator of poor quality.…”

Section: Methods Development and Validation For Ophthalmic Formulationsmentioning

confidence: 99%

Method Development and Validation for Ophthalmic Formulations Containing Antibiotics: A Comprehensive Review

Thapar¹,

Chawla²,

Gupta³

2023

IJPS

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Bacterial conjunctivitis commonly referred to as pink eye, having an inflammation of the conjunctiva either due to infection or an allergic condition. The outer lining of the white part of our eye gets reddish or pink in color. Ophthalmic antibiotics are instilled for curing this condition. Many ophthalmic formulations are available in the market for curing this condition. Most of them contain an antibiotic along with a steroidal moiety. Method development plays a pivotal role in drug testing, manufacturing operations, stability studies and the long term performance of drugs. International Council for Harmonisation provides guidelines for validating analytical methods. With minimal use of time and money scientists all over the world are developing new methods for the same. Several studies have already been done for the method development of such ophthalmic solutions but still, some antibiotics remain untouched. This review article emphasizes detailed information regarding the methods developed for ophthalmic formulations and their validation as well.

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Section: Methods Development and Validation For Ophthalmic Formulationsmentioning

confidence: 99%

Method Development and Validation for Ophthalmic Formulations Containing Antibiotics: A Comprehensive Review

Thapar¹,

Chawla²,

Gupta³

2023

IJPS

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“…The current strategy focused on isocratic highperformance liquid chromatography method for the estimation of Midostaurin. After performing extensive literature Survey on chromatographic analysis of several dosage forms (Desai et al, 2019;Sangameshwar et al, 2019), an attempt was made to develop a new valid (Vidushi and Meenakshi, 2017) , elementary, speedy and Decisive method for the estimation of Midostaurin in a ixed dosage form.…”

Section: Introductionmentioning

confidence: 99%

RP-HPLC Method Development and Validation for the Estimation of Midostaurin in Bulk and Pharmaceutical Dosage Form

Harikrishnan

Subramanian

Hemalatha

et al. 2020

ijrps

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An elementary, Valid, speedy and decisive strategy was developed to determine Midostaurin quantitatively in a fixed dosage form. Effective Chromatographic separation of Midostaurin was achieved by using Hypersil C18 Column (250 mm X 4.6 mm internal diameter, five μm particle size) using a mobile phase composed of Methanol and Buffer in the proportion of 75:25(by volume). The Mobile phase was siphoned using a gradient HPLC system at a flow rate of 1.0 ml/min, and quantification was based on peak area measurement at 270 nm. RT (Retention Time) for Midostaurin was 2.142 min, and dimensionality of Midostaurin was found to be linear with a statistic value of 0.999. The acceptance criteria of precision were relative variance should be less than 2.0%, and also the strategy showed precision 0.3 for Midostaurin, which shows that the tactic was precise. The full Recovery was found to be 99.96 %. Detection Limit and Quantitation Limit values for Midostaurin were found as 0.439 & 1.466. The exactness and authenticity were assessed by evaluation of validation parameters like linearity, precision, specificity, accuracy, LOD, LOQ values as per ICH guidelines. The proposed strategy has been applied to the formulation without additives interference and specific for the estimation of Midostaurin.

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“…There are several methods available for the determination of potential impurities at API stage of dabigatran. But there is no single HPLC method available for these twelve impurities of dabigatran (Desai et al, 2019).…”

Section: Introductionmentioning

confidence: 99%

A Validated RP-HPLC method for related substances of Dabigatran etexilate mesylate

D¹,

Jain²,

G³

2020

ijrps

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The scope of this research work was to develop a reverse-phase liquid chromatographic method for the quantification of related impurities of dabigatran and to validate the method according to ICH guidelines. Chromatographic conditions were optimised with Poroshell SB C18, 150mm, 4.6mm, 2.7µm particle size column, mixer of Phosphate buffer with phosphoric acid in water and acetonitrile with percentage of 10:90 (v/v) as solvent-A and acetonitrile and buffer with a percentage of 70:30 (v/v) as solvent-B. Gradient compassion mode is employed for mobile phase delivery with a flow rate of 0.8 mL/min. Stationary phase was maintained at 35°C temperature and detection at 230 nm, with 10 µL of sample injection volume. Water and acetonitrile in the percentage 30:70(v/v) were used as a diluent. The developed RP-HPLC method was validated according to ICH guidelines. LOD and LOQ values for dabigatran its impurities were in the range from 33 to 55 ppm and 112 to 168 ppm correspondingly. Method validation results for all the parameters are meeting the ICH guidelines acceptance criteria for the parameters of robustness, ruggedness, linearity, reproducibility and recovery. The proposed method was found to be suitable for the quantitative determination of potential impurities in the bulk samples of Dabigatran etexilate mesylate API.

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High Performance Liquid Chromatography-A Validation View

Cited by 8 publications

References 0 publications

Method Development and Validation for Ophthalmic Formulations Containing Antibiotics: A Comprehensive Review

Method Development and Validation for Ophthalmic Formulations Containing Antibiotics: A Comprehensive Review

RP-HPLC Method Development and Validation for the Estimation of Midostaurin in Bulk and Pharmaceutical Dosage Form

A Validated RP-HPLC method for related substances of Dabigatran etexilate mesylate

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