scholarly journals Development and Validation of HPTLC Method for Estimation of Safinamide Mesylate in Bulk and in Tablet Dosage Form

2012 ◽  
Vol 2012 ◽  
pp. 1-4 ◽  
Author(s):  
Vivekkumar K. Redasani ◽  
Bhushan J. Mali ◽  
Sanjay J. Surana
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Cost Effective ◽  
Phase Detection ◽  
Aluminum Plates ◽  
Development And Validation ◽  
Tablet Dosage ◽  
Hptlc Method

A simple, specific, and precise high-performance thin-layer chromatographic method has been developed and validated for estimation of Safinamide Mesylate as bulk and in tablet dosage form. The chromatographic development was carried out on aluminum plates precoated with silica gel 60 F254 using a mixture of Toluene: Methanol: Triethylamine (4 : 1 : 0.5 v/v) as mobile phase. Detection was carried out densitometrically at 226 nm. The value of drug was found to be . The method was validated with respect to linearity, accuracy, precision, and robustness. The calibration curve was found to be linear over a range of 400–2400 ng μL−1. The % assay (Mean ± S.D.) was found to be . Accuracy of the method was accessed by percentage recovery and found to be . Thus the proposed HPTLC method was found to provide fast and cost-effective quantitative control for routine analysis of Safinamide mesylate as bulk and in tablet dosage form.

A VALIDATED METHOD FOR THE DETERMINATION OF TAPENTADOL HYDROCHLORIDE IN BULK AND ITS PHARMACEUTICAL FORMULATION BY DENSITOMETRIC ANALYSIS

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (12) ◽  
pp. 51-55
Author(s):  
S Kathirvel ◽  
◽  
K. Madhu Babu
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Glacial Acetic Acid ◽  
Calibration Plot ◽  
Pharmaceutical Dosage Form ◽  
Aluminum Plates ◽  
Tablet Dosage

Described in this manuscript is the first reported new, simple high performance thin layer chromatographic method for the determination of tapentadol hydrochloride in bulk and its tablet dosage form. The drug was separated on aluminum plates precoated with silica gel 60 F254 with butanol: water: glacial acetic acid in the ratio of 6:2:2 (v/v/v) as mobile phase. Quantitative analysis was performed by densitometric scanning at 254 nm. The method was validated for linearity, accuracy, precision and robustness. The calibration plot was linear over the range of 200-600 ng band -1 for tapentadol hydrochloride. The method was successfully applied to the analysis of drug in a pharmaceutical dosage form.

VALIDATED HPTLC METHOD FOR SIMULTANEOUS DETERMINATION OF OLMESARTAN MEDOXIMIL AND METOPROLOL SUCCINATE IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (10) ◽  
pp. 13-17
Author(s):  
V. V Kunjir ◽  
◽  
S. B. Jadhav ◽  
A. J Purkar ◽  
P. D. Chaudhari
Keyword(s):  
Simultaneous Determination ◽  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Metoprolol Succinate ◽  
Ich Guidelines ◽  
Tablet Dosage ◽  
Hptlc Method

A high performance thin layer chromatographic method has been developed for the simultaneous determination of olmesartan medoximil and metoprolol succinate from tablet dosage form. The mobile phase consisting of water-methanol-ammonium sulphate (4.5:4.5:1.5 v/v/v) and wavelength of detection 233 nm was used. The developed method was validated as per ICH guidelines.

scholarly journals Development and Validation of HPTLC Method for Estimation of Propranolol Hydrochloride and Flunarizine Dihydrochloride in Combined Dosage Form

2012 ◽  
Vol 2012 ◽  
pp. 1-6
Author(s):  
Palak Patel ◽  
Kashyap K. Bhatt
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Limit Of Detection ◽  
Solvent System ◽  
Propranolol Hydrochloride ◽  
Limit Of Quantification ◽  
Aluminum Plates ◽  
Development And Validation ◽  
Hptlc Method

A simple, sensitive, and precise high-performance thin layer chromatographic method has been developed for the estimation of propranolol hydrochloride and Flunarizine dihydrochloride in combined dosage form. The method employed HPTLC aluminum plates precoated with silica gel 60F as the stationary phase while the solvent system was toluene:methanol: ethyl acetate: acetic acid (7 : 1.5 : 1.5 : 0.1 v/v/v/v). The Rf value was observed to be 0.07±0.02 and 0.67±0.02 for propranolol hydrochloride and flunarizine dihydrochloride. The densitometric analysis was carried out in absorbance mode at 240 nm. The method was linear in the range of 400–2400 ng/band for propranolol hydrochloride and 50–300 ng/band for flunarizine dihydrochloride. The method was validated with respected accuracy, precision and specificity. The limit of detection for Propranolol hydrochloride and flunarizine dihydrochloride were found to be 118.4 and 13.75 ng/spot, respectively. The limit of quantification for propranolol hydrochloride and flunarizine dihydrochloride was found to be 355.2 and 45.4 ng/band, respectively. The method was successfully applied to the estimation of propranolol hydrochloride and flunarizine dihydrochloride in combined dosage form.

scholarly journals High Performance Thin Layer Chromatographic Method for Estimation of Cefprozil in Tablet Dosage Form

2008 ◽  
Vol 5 (3) ◽  
pp. 427-430 ◽  
Author(s):  
V. Jagapathi Raju ◽  
J. V. L. N. Seshagiri Rao
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Dosage Forms ◽  
Diethyl Amine ◽  
Phase Quantification ◽  
Tablet Dosage ◽  
Chloroform Methanol ◽  
Hptlc Method

A simple, fast, specific and precise HPTLC method has been developed for the estimation of cefprozil in pure and in tablet dosage forms. Aluminium plates precoated with silica gel G60F254were used as stationary phase and a mixture of chloroform: methanol: toluene: diethyl amine: water in the ratio 4: 4.4: 3.2: 3: 0.8 v/v as mobile phase. Quantification was carried out by the use of a densitometer in absorbance mode at 286 nm. The Rfvalue of cefprozil was found to be between 0.37 and 0.40. The results of the analysis have been validated statistically and by recovery studies. Linearity was observed in the concentration range of 400-2000 ng/spot.

scholarly journals NOVEL HPTLC-DENSITOMETRIC METHOD FOR THE ESTIMATION OF TERIFLUNOMIDE IN TABLET DOSAGE FORM

2019 ◽  
pp. 80-84
Author(s):  
T. S. Vishwas ◽  
B. M. Gurupadayya ◽  
Rupshee Jain
Keyword(s):  
Quality Control ◽  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Glacial Acetic Acid ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Aluminum Plates ◽  
Tablet Dosage ◽  
Hptlc Method

Objective: The current work is intended towards the development of a novel, simple and precise high-performance thin layer chromatographic (HPTLC) method coupled with a densitometer for the estimation of teriflunomide (TEF) present in the marketed formulation. Methods: The chromatographic development was performed on aluminum plates coated with silica gel 60 F254 using toluene: ethyl acetate: glacial acetic acid (7.5:2: 0.5 v/v/v) as the mobile phase. Densitometric scanning was achieved at the absorbance maxima, UV 284 nm. Results: Well separated band was observed with Rf value 0.46. The calibration curve plotted in the concentration range 100-700ng/band exhibited an excellent linear relationship with the r2 value of 0.9928. The method was found to comply with all the validation parameters as per the ICH guidelines. Conclusion: The method ensures minimal use of mobile phase with minimal run time compared to other reported analytical methods. This validated method can be used by quality control laboratories for the routine quantitative analysis of tablets consisting of Teriflunomide.

scholarly journals Development and validation of high performance thin layer chromatographic method for the determination of voglibose in bulk and their formulations

2020 ◽  
Vol 9 (2) ◽  
pp. 1074-1078
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Chromatographic Method ◽  
Cost Effective ◽  
Band Size ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Aluminum Plates ◽  
Development And Validation

To develop a simple, fast, specific, precise and accurate High Performance Thin Layer Chromatographic method (HPTLC) for the determination of Voglibose in bulk and their dosage forms. The chromatographic separation was achieved on precoated silica gel 60F254 aluminum plates using a combination of acetonitrile: methanol: ammonia (15:4:0.1 % V/V/V) as mobile phase and densitometric evaluation of spots was carried out at 284 nm using Camag TLC scanner III with CATS 1.3.4 version software. The experimental parameters like band size of the chamber saturation time, spot application, slit width, solvent front migration, etc. were studied critically and evolved optimized conditions. The drug was well resolved satisfactorily with Rf value 0.66±0.03. The repeatability and accuracy of the optimized method were ascertained by evaluating various validation parameters like linearity (100 to 450 ng/spot), precision (intra-day % RSD 0.21 to 0.74, inter-day % RSD 0.21 to 0.29), accuracy (99.8% to 101.2%, % RSD below 1%), and specificity according to ICH guidelines. The limits of detection and quantification were 40 ng/spot and 100 ng/spot respectively. The developed HPTLC method was faster and cost effective quantitative control for routine analysis of Voglibose in bulk and its formulations.

scholarly journals A NEW HIGH PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN IN BULK AND TABLET DOSAGE FORM

2019 ◽  
pp. 58-63
Author(s):  
B. V. SUMA ◽  
DEVESWARAN R. ◽  
PREMNATH SHENOY
Keyword(s):  
Thin Layer ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Method Development ◽  
Retention Factor ◽  
Accurate Analysis ◽  
Development And Validation ◽  
Tablet Dosage

ABSTRACT Objective: To develop a new simple, selective and precise high-performance thin layer chromatographic method for determination of Dapagliflozin (DAPA) in bulk and tablet dosage form Methods: The present study describes development and validation of High performance thin layer chromatographic method for DAPA. The chromatographic separation was carried out on Merck precoated silica gel aluminium plate 60 F254 using Chloroform: Methanol (9:1v/v) as mobile phase. Quantitative determination of drug was carried out by densitometric scanning of plates at 223 nm using Camag TLC Scanner. Results: The chromatographic condition shows compact band with the retention factor for dapaglifloxin as 0.21 ± 0.004. The method was validated as per ICH guidelines for linearity, accuracy, precision and robustness. Response was found to be linear in the concentration range of 400 ng/ band to 1200 ng/band with linear regression value of 0.9953 with respect to peak area and concentration value The LOD and LOQ was found to be 1.2083 ng/band and 3.6616ng/ band. The percentage assay was found to be 100±0.05. Conclusion: This method under statistical analysis proved a selective, repeatable and accurate analysis of the drug. This method can be used for quantitative analysis of dapaglifloxin in the bulk drug and in tablet.    

scholarly journals DEVELOPMENT AND VALIDATION OF HIGH-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR DETERMINATION OF DAPAGLIFLOZIN AND ITS IMPURITIES IN TABLET DOSAGE FORM

2019 ◽  
pp. 447-453
Author(s):  
CAROLINE GRACE A ◽  
PRABHA T ◽  
SIVAKUMAR T
Keyword(s):  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Chromatographic Method ◽  
High Performance Liquid Chromatographic ◽  
Good Precision ◽  
Liquid Chromatographic Method ◽  
Tablet Dosage ◽  
Liquid Chromatographic

Objective: The aim of the present work is the development of new, sensitive, specific, and accurate high-performance liquid chromatographic method for the separation and determination of dapagliflozin and its impurities in tablet dosage form. Methods: The chromatographic separation of drug and its impurities was achieved using Hypersil BDS C18 column (250 mm × 4.6 mm, 5 μ) with mobile phase consisted of mobile phase-A (Buffer pH 6.5) and mobile phase-B (acetonitrile:water 90:10) by gradient program at a flow rate of 1 mL/min with ultraviolet detection at 245 nm. Results: Dapagliflozin and its impurities A, B, C, D, E, and impurity-F were successfully eluted at the retention time of 16.95, 2.72, 7.82, 10.58, 21.11, 30.37, and 34.36 min, respectively, with good resolution. The method was validated according to the international conference on harmonization guidelines. The validation results showed good precision, accuracy, linearity, specificity, sensitivity, and robustness. Conclusion: Successful separation and determination of dapagliflozin and its six impurities were achieved by the proposed method. The developed method can be applied for the routine analysis of dapagliflozin and its impurities in pharmaceutical 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.

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