Design Expert-Supported Development and Validation of High-Performance Thin-Layer Chromatographic Stability-Indicating (HPTLC) Method: an Application in Quantitative Analysis of Ropinirole in the Bulk Drug and in Marketed Dosage Forms

2012 ◽  
Vol 7 (2) ◽  
pp. 47-55 ◽  
Author(s):  
Gulam Mustafa ◽  
Sanjula Baboota ◽  
Javed Ali ◽  
Alka Ahuja
Keyword(s):  
Quantitative Analysis ◽  
Thin Layer ◽  
High Performance ◽  
Dosage Forms ◽  
Design Expert ◽  
Stability Indicating ◽  
Bulk Drug ◽  
Development And Validation ◽  
Hptlc Method

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR DETERMINATION OF APIXABAN AS BULK DRUG

2019 ◽  
pp. 37-42
Author(s):  
Mrinalini C. Damle ◽  
Swapnil S Waghmare ◽  
PURUSHOTAM SINHA
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Limit Of Detection ◽  
Chromatography Method ◽  
Stability Indicating ◽  
Chromatographic Condition ◽  
Bulk Drug ◽  
Development And Validation ◽  
Hptlc Method

Objective: To develop and validate simple, sensitive stability indicating HPTLC (High performance thin layer chromatography) method for apixaban. Methods: The chromatographic separation was performed on aluminium plates precoated with silica gel 60 F254 using toluene: ethyl acetate: methanol (3:6:1 v/v/v) as mobile phase followed by densitometric scanning at 279 nm. Results: The chromatographic condition shows sharp peak of apixaban at Rf value of 0.38±0.03. Stress testing was carried out according to international conference on harmonization (ICH)Q1A (R2) guidelines and the method was validated as per ICH Q2(R1) guidelines. The calibration curve was found to be linear in the concentration range of 100-500 ng/band for apixaban. The limit of detection and quantification was found to be 11.66ng/bandand35.33ng/band, respectively. Conclusion: A new simple, sensitive, stability indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for the determination of apixaban.

scholarly journals DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPTLC METHOD FOR ESTIMATION OF SWERTIAMARIN IN BULK AND DOSAGE FORM

2017 ◽  
Vol 9 (6) ◽  
pp. 80
Author(s):  
H. Padh ◽  
S. Parmar ◽  
B. Patel
Keyword(s):  
High Performance ◽  
Forced Degradation ◽  
Stability Indicating ◽  
Bulk Drug ◽  
Development And Validation ◽  
Layer Chromatography ◽  
Herbal Formulations ◽  
Hptlc Method ◽  
Ich Guideline

Objective: In the present study a novel stability-indicating high-performance thin-layer chromatography (HPTLC) method for quantitative determination of Swertiamarin (SW) in bulk drug and formulation has been developed and validated as per ICH guideline Q2 (R1) for global acceptance of standardized herbal formulations.Methods: HPTLC method is developed and validated using solvent ethyl acetate: ethanol: chloroform (3:2.5:4.5 v/v/v) (Rf of SW 0.65±0.04) in the absorbance mode at 243 nm. Various forced degradation conditions were used to check degradation of drug.Results: The method showed a good linear relationship (r2 = 0.9990) in the concentration range 200-700 ng per spot. It was found to be linear, accurate, precise and specific.Conclusion: It can be applied for quality control as well as for stability testing of different dosage forms containing swertiamarin. The developed method is validated as per ICH guideline Q2(R1) for global acceptance of standardized herbal formulations.

scholarly journals Development and Validation of Stability-Indicating HPTLC Method for Determination of Solifenacin Succinate as bulk Drug and in Tablet Dosage Form

2016 ◽  
Vol 8 (04) ◽  
Author(s):  
M.C. Damle ◽  
P. Rokade
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Retention Factor ◽  
Stability Indicating ◽  
Solifenacin Succinate ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Hptlc Method

A new simple, stability- indicating high performance thin layer chromatographic (HPTLC) method has been developed and validated for estimation of Solifenacin succinate in bulk and in tablet dosage form. The optimized mobile phase was Methanol: Water: Glacial acetic acid (9:1:0.1v/v/v) with UV detection at 216 nm. The retention factor for Solifenacin succinate was found to be 0.49 ± 0.03. The drug was subjected to stress conditions of hydrolysis under different pH conditions, oxidation, photolysis and thermal degradation as per ICH guidelines. Results were found to be linear in the concentration range of 2000-10000ng band-1.

HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE FROM BULK AND IT'S ORAL FORMULATION

INDIAN DRUGS ◽  
2017 ◽  
Vol 54 (02) ◽  
pp. 53-61
Author(s):  
A Shirode ◽  
◽  
A. Nath ◽  
V. Kadam
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Oral Formulation ◽  
Control Analysis ◽  
Uv Detector ◽  
Analytical Method Validation ◽  
Starting Position ◽  
Hydrochloride Monohydrate ◽  
Bulk Drug ◽  
Hptlc Method

A simple and selective high performance thin layer chromatographic (HPTLC) method was developed and validated for the estimation of ziprasidone hydrochloride monohydrate (ZHM) from its marketed formulation and oral formulation. The CAMAG HPTLC system, operated with software winCATS (ver.1.4.1.8) was used for proposed analytical work. Planar chromatographic development was carried out with the help of silica gel 60 F254 precoated aluminium TLC plates. Sample application was employed using Linomat 5 applicator. The optimized mobile phase was composed of toluene: glacial acetic acid: methanol (6: 0.3: 3 V/V/V). The detection of spots was carried out densitometrically using a UV detector at 317nm in absorbance mode. In HPTLC densitogram well defined peak was obtained for ZHM with starting position at 59 hRf, max position at 63 hRf and end position at 65 hRf. The optimum hRf value for ZHM was found to be 63. Performance characteristics of HPTLC method for estimation of ZHM in bulk drug and its marketed dosage form were statistically validated as per recommendations of ICH guidelines of analytical method validation. The HPTLC method was found to be linear across the range 20-140 ng/band. The LOD and LOQ values were found to be 13.573 and 41.130 ng/band, respectively. The method was found to be accurate, precise, robust and economical for the analysis of ZHM from bulk drug and its formulation. The proposed analytical HPTLC method can be used for routine quality-control analysis of ZHM.

scholarly journals Quantitative Analysis of Sulpiride and Impurities of 2-Aminomethyl-1-Ethylpyrrolidine and Methyl-5-Sulphamoyl-2-Methoxybenzoate in Pharmaceuticals by High-Performance Thin-Layer Chromatography and Scanning Densitometry

1999 ◽  
Vol 82 (4) ◽  
pp. 825-829 ◽  
Author(s):  
Danica Agbaba ◽  
Tatjana Miljkovic ◽  
Valentina Marinkovic ◽  
Dobrila Zivanov-Stakic ◽  
Sote Vladimirov
Keyword(s):  
Quantitative Analysis ◽  
Thin Layer ◽  
High Performance ◽  
Methylene Chloride ◽  
Solvent System ◽  
Ammonia Solution ◽  
Dosage Forms ◽  
Raw Material ◽  
Layer Chromatography

Abstract A simple and reliable thin-layer chromatographic method for determining sulpiride and impurities of 2-aminomethyl-1-ethylpyrrolidine and methyl-5-sulphamoyl-2-methoxybenzoate was developed and validated. A methylene chloride–methanol–ammonia solution (25%; 18 + 2.8 + 0.4, v/v) solvent system is used for separation and quantitative evaluation of chromatograms. The chromatographic plate is first scanned at 240 nm to locate chromatographic zones corresponding to sulpiride and methyl-5-sulphamoyl-2-methoxybenzoate. Then 2-aminomethyl-1-ethylpyrrolidine is derivatized in situ with ninhydrin, and resulting colored spots are measured at 500 nm. The method is reproducible and convenient for quantitative analysis and purity control of sulpiride in its raw material and in its dosage forms.

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