scholarly journals Development and validation of HPTLC method for the analysis of Olmutinib in Bulk drug

2020 ◽  
Vol 13 (1) ◽  
pp. 37-43
Author(s):  
Balu S. Khandare
Keyword(s):  
Regression Analysis ◽  
Linear Regression ◽  
High Performance ◽  
Linear Regression Analysis ◽  
Solvent System ◽  
Average Recovery ◽  
Bulk Drug ◽  
Development And Validation ◽  
Hptlc Method

This paper describes a simple, precise, rapid and accurate high- performance thin layer chromatographic (HPTLC) method for determination of Olmutinib in bulk drug. Chroma to graphic separation was per formed on aluminium plates precoated with silicagel60F254 as the stationary phase using solvent system consisted of chloro form: methanol: (9:1v/v). After the application of bands using CAMAG Automatic TLC Sampler 4, the plate was developed in the solvent system up to 70 mm in CAMAGT win Trough Chamber. This solvent system was found to give compact spot for Olmutinib with Rfvalue of 0.32±0.02. The spots were scanned at 267.68nm. The calibration curves were linear with co-relation coefficient of 0.995 for Olmutinib. Linear regression analysis showed good linearity in the concentration range of 100- 1100 ng per spot. The method was validated in terms of Precision, specificity, and Linearity. The average recovery of the standards in the samples was found to be 99.65% at the same time we have checked the C.V. values of Reproducibility, intra-day and inter-day tabulated further. The proposed method can be successfully applied to determine the drug content of bulk drug.

scholarly journals Development and Validation of an HPTLC Method for Determination of Olanzapine in Formulations

2010 ◽  
Vol 93 (3) ◽  
pp. 811-819 ◽  
Author(s):  
Rashmin B Patel ◽  
Mrunali R Patel ◽  
Kashyap K Bhatt ◽  
Bharat G Patel
Keyword(s):  
Regression Analysis ◽  
Statistical Analysis ◽  
Mobile Phase ◽  
Linear Regression Analysis ◽  
Analysis Data ◽  
Equilibrium Solubility ◽  
Bulk Drug ◽  
Development And Validation ◽  
Hptlc Method

Abstract A new, simple, and rapid HPTLC method was developed and validated for quantitative determination of olanzapine on silica gel 60F254 layers using methanolethyl acetate (8.0 + 2.0, v/v) as the mobile phase. Olanzapine was quantified by densitometric analysis at 285 nm. The method was found to give compact bands for the drug (Rf = 0.35 0.02). The linear regression analysis data for the calibration plots showed a good linear relationship with r2 = 0.9997 in the concentration range of 100600 ng/band. The method was validated for precision, recovery, repeatability, and robustness as per the International Conference on Harmonization guidelines. The LOD was found to be 23.90 ng/band, and the LOQ was 91.04 ng/band. Statistical analysis of the data showed that the method is precise, accurate, reproducible, and selective for the analysis of olanzapine. The method was successfully used for the determination of equilibrium solubility and quantification of olanzapine as a bulk drug, in a commercially available preparation, and in in-house developed mucoadhesive microemulsion formulations and solution.

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 a Reversed-Phase High-Performance Thin-Layer ChromatographyDensitometric Method for Determination of Atorvastatin Calcium in Bulk Drug and Tablets

2010 ◽  
Vol 93 (3) ◽  
pp. 798-803 ◽  
Author(s):  
Atul A Shirkhedkar ◽  
Sanjay J Surana
Keyword(s):  
High Performance ◽  
Linear Regression Analysis ◽  
Analysis Data ◽  
Reversed Phase ◽  
Atorvastatin Calcium ◽  
Aluminum Sheets ◽  
Compact Band ◽  
Bulk Drug ◽  
Development And Validation

Abstract Atorvastatin calcium is a synthetic HMGCoA reductase inhibitor that is used as a cholesterol-lowering agent. A simple, sensitive, selective, and precise RP-HPTLCdensitometric determination of atorvastatin calcium both as bulk drug and from pharmaceutical formulation was developed and validated according to International Conference on Harmonization guidelines. The method used aluminum sheets precoated with silica gel 60 RP18F254s as the stationary phase, and the mobile phase consisted of methanolwater (3.5 + 1.5, v/v). The system gave a compact band for atorvastatin calcium with an Rf value of 0.62 0.02. Densitometric quantification was carried out at 246 nm. The linear regression analysis data for the calibration plots showed a good linear relationship with r = 0.9992 in the working concentration range of 100-800 ng/band. The method was validated for precision, accuracy, ruggedness, robustness, specificity, recovery, LOD, and LOQ. The LOD and LOQ were 6 and 18 ng, respectively. The drug underwent hydrolysis when subjected to acidic conditions and was found to be stable under alkali, oxidation, dry heat, and photodegradation conditions. Statistical analysis proved that the developed RP-HPTLCdensitometry method is reproducible and selective and that it can be applied for identification and quantitative determination of atorvastatin calcium in bulk drug and tablet formulation.

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 HPTLC Method for Estimation of Carbamazepine in Formulations and Its In Vitro Release Study

2011 ◽  
Vol 2011 ◽  
pp. 1-8 ◽  
Author(s):  
Rashmin B. Patel ◽  
Mrunali R. Patel ◽  
Kashyap K. Bhatt ◽  
Bharat G. Patel
Keyword(s):  
High Performance ◽  
Linear Regression Analysis ◽  
In Vitro Release ◽  
Analysis Data ◽  
Limit Of Quantitation ◽  
Bulk Drug ◽  
Development And Validation ◽  
Vitro Release

A new, simple, and rapid high-performance thin-layer chromatographic method was developed and validated for quantitative determination of Carbamazepine. Carbamazepine was chromatographed on silica gel 60 F254 TLC plate using ethyl acetate-toluene-methanol (5.0 + 4.0 + 1.0 v/v/v) as mobile phase. Carbamazepine was quantified by densitometric analysis at 285 nm. The method was found to give compact spots for the drug (Rf=0.47 ± 0.01). The linear regression analysis data for the calibration plots showed good linear relationship with r2=.9995 in the concentration range 100–600 ng/spot. The method was validated for precision, recovery, repeatability, and robustness as per the International Conference on Harmonization guidelines. The minimum detectable amount was found to be 16.7 ng/spot, whereas the limit of quantitation was found to be 50.44 ng/spot. Statistical analysis of the data showed that the method is precise, accurate, reproducible, and selective for the analysis of Carbamazepine. The method was successfully employed for the estimation of equilibrium solubility, quantification of Carbamazepine as a bulk drug, in commercially available preparation, and in-house developed mucoadhesive microemulsion formulations and solution.

Evaluation and comparison of a radiative energy attenuation method for determining cholesterol in serum.

1985 ◽  
Vol 31 (4) ◽  
pp. 605-608 ◽  
Author(s):  
P L Cary ◽  
C A Johnson ◽  
P D Whitter ◽  
J W Parker
Keyword(s):  
Regression Analysis ◽  
Linear Regression ◽  
High Performance ◽  
Linear Regression Analysis ◽  
Radiative Energy ◽  
Comparison Methods ◽  
Analytical Recovery ◽  
Wide Range

Abstract Determination of cholesterol by a radiative energy attenuation (REA) technique was evaluated and compared with results obtained by the Boehringer Mannheim High Performance Cholesterol Assay and the Du Pont aca. Within-assay and between-assay CVs for the REA method, for two sets of controls, were both less than 5%. We observed no interference with lipemic samples. Analytical recovery averaged 102.8%. We used all three methods for parallel determinations of 217 patients' samples containing a wide range of cholesterol concentrations. Linear regression analysis of the REA results vs those of the comparison methods were as follows: REA = 1.03 Boehringer - 0.072 (r = 0.993) and REA = 1.02 aca - 0.048 (r = 0.995). We also discuss bilirubin interference with the REA method for cholesterol.

scholarly journals Quantification of Gymnemagenin and β-Sitosterol in Marketed Herbal Formulation by Validated Normal Phase HPTLC Method

2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Sachin E. Potawale ◽  
Satish Y. Gabhe ◽  
Kakasaheb R. Mahadik
Keyword(s):  
High Performance ◽  
Research Study ◽  
Retention Factor ◽  
Solvent System ◽  
Polyherbal Formulation ◽  
Herbal Formulation ◽  
Acid Reagent ◽  
Development And Validation ◽  
Hptlc Method

This research study describes development and validation of new, rapid, accurate, robust, and precise, high performance thin layer chromatographic (HPTLC) method for concurrent quantitative determination of gymnemagenin and β-sitosterol in herbal formulation with densitometric detection. Chromatographic separation was achieved on Merck aluminum HPTLC plates precoated with silica gel 60 F254. The optimized solvent system consisted of toluene : ethyl acetate : methanol (6.5 : 2.5 : 1.4, v/v/v). Developed plates were derivatized with 5% sulphuric acid reagent followed by heating at 110°C for 4 min in a preheated oven and scanned at 423 nm in reflectance-absorbance mode. The retention factor for gymnemagenin and β-sitosterol was found to be 0.27±0.02 and 0.78±0.02, respectively. The proposed densitometric method was validated according to ICH Q2 (R1) guidelines. Results were found to be linear over a range of 100–1200 ng band−1 and 200–1200 ng band−1 for gymnemagenin and β-sitosterol, respectively. The percent content of gymnemagenin and β-sitosterol in the marketed polyherbal formulation was found to be 0.0405% and 0.1377%, respectively. The proposed HPTLC method can be used for quantification of gymnemagenin and β-sitosterol in marketed polyherbal formulation used in the study in quality-control laboratories.

scholarly journals HPTLC method development and validation of stigmasterol from different extracts of Tagetes erecta and Capsicum annuum

2019 ◽  
Vol 9 (6) ◽  
pp. 169-172
Author(s):  
Mohal Lal ◽  
Aboli Kadam ◽  
Aishwarya S. Padole
Keyword(s):  
Thin Layer ◽  
Capsicum Annuum ◽  
High Performance ◽  
Method Development ◽  
Linear Regression Analysis ◽  
Analysis Data ◽  
Tagetes Erecta ◽  
Development And Validation ◽  
Hptlc Method

A new, simple, sensitive, selective, precise and robust high-performance thin-layer chromatographic (HPTLC) method for analysis of stigmasterol was developed and validated for the determination of stigmasterol in different extracts. A new, simple, sensitive, selective, precise and robust high-performance thin-layer chromatographic (HPTLC) method for analysis of stigmasterol was developed and validated for the determination of stigmasterol in different extracts. Analysis of stigmasterol was performed on TLC aluminium plates pre-coated with silica gel 60F-254 as the stationary phase. Linear ascending development was carried out in twin trough glass chamber saturated with mobile phase consisting of Hexane : Acetone (8:2 v/v) at room temperature. (25 °C ± 2 °C) Camag TLC scanner III was used for spectrodensitometric scanning and analysis in absorbance mode at 490nm. The system was found to give compact spots for stigmasterol. (Rf value of 0.44 ± 0.02) The linear regression analysis data for the calibration plots showed good linear relationship with r2 =0.9997 ± 0.0002 in the concentration range 200-1200 ng spot−1 with respect to peak area. According to the International Conference on Harmonization (ICH) guidelines the method was validated for precision, recovery and robustness. Statistical analysis of the data showed that the method is reproducible and selective for the estimation of stigmasterol. Keywords: Tagetes erecta, Capsicum annuum, stigmasterol, HPTLC, method validation

scholarly journals Assay of Clopidogrel by Using HPLTC Method

2018 ◽  
pp. 557-561
Author(s):  
D. S. Ghotekar ◽  
Vishal N. Kushare
Keyword(s):  
Regression Analysis ◽  
Linear Regression ◽  
Thin Layer ◽  
Stationary Phase ◽  
High Performance ◽  
Linear Regression Analysis ◽  
Analysis Data ◽  
Solvent System ◽  
Assay Method ◽  
Layer Chromatography

The present paper describes stability indicating high-performance thin-layer chromatography (HPTLC) assay method for clopidogrel in bulk drugs. The method employed TLC aluminium plates precoated with silica gel 60F-254 as the stationary phase. The solvent system consisted of toluene: methanol: triethylamine (6.5: 4.0: 0.1 v/v/v). The system was found to give compact spot for clopidogrel (<em>R</em><sub>f</sub>value of 0.40 ± 0.010). Densitometric analysis of Clopidogrel was carried out in the absorbance mode at 254 nm. The linear regression analysis data for the calibration plots showed good linear relationship with <em>r</em>2 = 0.888 with respect to peak area in the concentration range 30 - 120 ng/spot.

scholarly journals Development and Validation of Stability-Indicating HPTLC Determination of Tamsulosin in Bulk and Pharmaceutical Dosage Form

2011 ◽  
Vol 2011 ◽  
pp. 1-6 ◽  
Author(s):  
S. B. Bari ◽  
A. R. Bakhshi ◽  
P. S. Jain ◽  
S. J. Surana
Keyword(s):  
High Performance ◽  
Linear Regression Analysis ◽  
Analysis Data ◽  
Solvent System ◽  
Mean Value ◽  
Pharmaceutical Dosage Form ◽  
Stability Indicating ◽  
Ich Guidelines ◽  
Bulk Drug ◽  
Development And Validation

A simple, economic, selective, precise, and stability-indicating high-performance thin-layer chromatographic method for analysis of tamsulosin hydrochloride, both as a bulk drug and in formulations, was developed and validated according to ICH guidelines. The method employed HPTLC aluminium plates precoated with silica gel 60F-254 as the stationary phase while the solvent system consisted of toluene  :  methanol  :  triethylamine (3.5  :  1.2  :  0.2 v/v). The system was found to give compact spot for drug ( value of ). Densitometric analysis of tamsulosin was carried out in the absorbance mode at 280 nm. The linear regression analysis data for the calibration plots showed good linear relationship, with respect to peak area in the concentration range 400–2400 ng per spot. The mean value ± SD of slope and intercept were and with respect to peak area. The method was validated for precision, recovery, and robustness. The limits of detection and quantitation were 20.49 and 62.10 ng per spot, respectively. Tamsulosin was subjected to hydrolysis, oxidation, and thermal degradation which indicate the drug is susceptible to hydrolysis, oxidation, and heat. Statistical analysis proves that the method is repeatable, selective, and accurate for the estimation of tamsulosin.

Sign in / Sign up

Export Citation Format

Share Document