STABILITY INDICATING HPTLC METHOD FOR THE ESTIMATION OF TICAGRELOR IN BULK AND IN PHARMACEUTICAL DOSAGE FORM

A simple, sensitive, and precise high-performance thin-layer chromatographic method has been developed for the estimation of Ticagrelor in pharmaceutical dosage form. The method employed Thin-layer chromatography (TLC) aluminum plates precoated with silica gel 60 F254 as the stationary phase, while the solvent system was found to be toluene: ethyl acetate: acetic acid (5:4:1V/V/V). The Rf value was observed to be 0.33± 0.008. The spot was densitometrically analyzed in absorbance mode at 305 nm. The method was linear in the range of 50-250 ng/ band for ticagrelor. The limit of detection for ticagrelor was found to be 0.826 ng/ band. The limit of quantification for ticagrelor was found to be 2.64 ng/band. Ticagrelor stock solution was subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation and photo degradation. The degraded product peaks were well resolved from the pure drug peak with significant difference in their Rf values. Stressed samples were assayed using developed HPTLC method. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of ticagrelor in its formulation.

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Stability-Indicating High-Performance Thin-Layer Chromatographic Method for Quantitative Estimation of Emtricitabine in Bulk Drug and Pharmaceutical Dosage Form

ISRN Chromatography ◽

10.5402/2012/278583 ◽

2012 ◽

Vol 2012 ◽

pp. 1-7 ◽

Cited By ~ 2

Author(s):

Atul S. Rathore ◽

Lohidasan Sathiyanarayanan ◽

Kakasaheb R. Mahadik

Keyword(s):

Thin Layer ◽

High Performance ◽

Dosage Form ◽

Limit Of Detection ◽

Linear Regression Analysis ◽

Solvent System ◽

Pharmaceutical Dosage Form ◽

Stability Indicating ◽

Limit Of Quantitation ◽

Bulk Drug

A simple, sensitive, precise, specific and stability indicating high-performance thin-layer chromatographic (HPTLC) method for the determination of emtricitabine both in bulk drug and pharmaceutical dosage form was developed and validated. The method employed aluminium plates precoated with silica gel G60 F254 as the stationary phase. The solvent system consisted of toluene : ethyl acetate : methanol (2 : 8 : 1, v/v/v). This solvent system was found to give compact spots for emtricitabine with value . Densitometric analysis of emtricitabine was carried out in the absorbance mode at 284 nm. Linear regression analysis showed good linearity with respect to peak area in the concentration range of 30–110 ng spot−1. The method was validated for precision, limit of detection (LOD), limit of quantitation (LOQ), robustness, accuracy and specificity. Emtricitabine was subjected to acid and alkali hydrolysis, oxidation, neutral hydrolysis, photodegradation and dry heat treatment. Also the degraded products peaks were well resolved from the pure drug with significantly different values. Statistical analysis proved that the method is repeatable and specific for the estimation of the said drug. As the method could effectively separate the drugs from their degradation products, it can be employed as a stability indicating method.

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

ISRN Analytical Chemistry ◽

10.5402/2012/502604 ◽

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.

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Development and Validation of HPTLC Method for Estimation of Cyamemazine Tartrate and its Formulation

International Journal of Pharmaceutical Quality Assurance ◽

10.25258/ijpqa.v8i1.8439 ◽

2017 ◽

Vol 8 (1) ◽

Author(s):

Sandip D. Firke ◽

Nikhil A. Patel ◽

Ravindra R. Patil

Keyword(s):

High Performance ◽

Dosage Form ◽

Limit Of Detection ◽

Limit Of Quantification ◽

Pharmaceutical Dosage Form ◽

Tlc Plates ◽

Rf Values ◽

Aluminium Sheets ◽

Bulk Drug ◽

Hptlc Method

A simple, precise, accurate high performance thin layer chromatographic (HPTLC) method has been developed for estimation of cyamemazine tartrate from a bulk drug and combined dosage form. The separation of drugs was carried out on Merck HPTLC aluminium sheets of Silica gel 60 F254 TLC plates as stationary phase and the chromatogram was developed using Benzene: Methanol (4.2:0.8v/v) as the mobile phase. Cyamemazine tartrate showed Rf values 0.45, when scanned densitometrically at 260 nm using Camag TLC Scanner. The described method was linear over a concentration range of 200 ng/spot to 1200 ng/spot for cyamemazine tartrate. Results of analysis were validated according to International Conference on Harmonization ICH Q2B guidelines statistically, and by recovery studies. The limit of detection (LOD) and limit of quantification (LOQ) for cyamemazine tartrate was found to be 28.47 ng/spot 86.29 ng/spot respectively. The results of the study showed that the proposed HPTLC method is simple, rapid, precise and accurate, which is useful for the routine determination of cyamemazine tartrate bulk drug and in its pharmaceutical dosage form.

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DETERMINATION OF 10-GINGEROL IN INDIAN GINGER BY VALIDATED HPTLC METHOD OF SAMPLES COLLECTED ACROSS SUBCONTINENT OF INDIA

International Journal of Pharmacy and Pharmaceutical Sciences ◽

10.22159/ijpps.2016v8i12.14953 ◽

2016 ◽

Vol 8 (12) ◽

pp. 190

Author(s):

Kamran Ashraf ◽

Syed Adnan Ali Shah ◽

Mohd Mujeeb

Keyword(s):

Thin Layer ◽

Thin Layer Chromatography ◽

High Performance ◽

Limit Of Detection ◽

Limit Of Quantification ◽

Chromatography Method ◽

Aluminum Plates ◽

Layer Chromatography ◽

Hptlc Method

Objective: A simple, sensitive, precise, and accurate stability indicating HPTLC (high-performance thin-layer chromatography) method for analysis of 10-gingerol in ginger has been developed and validated as perICH guidelines.Methods: The separation was achieved on TLC (thin layer chromatography) aluminum plates pre-coated with silica gel 60F254 using n-hexane: ethyl acetate 55:45 (%, v/v) as a mobile phase. Densitometric analysis was performed at 569 nm.Results: This system was found to have a compact spot of 10-gingerol at RF value of 0.57±0.03. For the proposed procedure, linearity (r2 = 0.998±0.02), limit of detection (18ng/spot), limit of quantification (42 ng/spot), recovery (ranging from 98.35%–100.68%), were found to be satisfactory.Conclusion: Statistical analysis reveals that the content of 10-gingerol in different geographical region varied significantly. The highest and lowest concentration of 10-gingerol in ginger was found to be present in a sample of Patna, Lucknow and Surat respectively which inferred that the variety of ginger found in Patna, Lucknow are much superior to other regions of India.

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DEVELOPMENT OF HPTLC METHOD FOR THE ESTIMATION OF ONDANSETRON AND RANITIDINE IN COMBINED DOSAGE FORM

INDIAN DRUGS ◽

10.53879/id.52.12.10321 ◽

2015 ◽

Vol 52 (12) ◽

pp. 42-48

Author(s):

P. J. Patel ◽

◽

D. A Shah ◽

F. A. Mehta ◽

U. K. Chhalotiya

Keyword(s):

Thin Layer ◽

Stationary Phase ◽

Thin Layer Chromatography ◽

Silica Gel ◽

High Performance ◽

Dosage Form ◽

Solvent System ◽

Rf Values ◽

Layer Chromatography ◽

Hptlc Method

A simple, sensitive and precise high performance thin layer chromatographic (HPTLC)method has been developed for the estimation of ondansetron (OND) and ranitidine (RAN) in combination. The method was employed on thin layer chromatography (TLC) and aluminium plates were precoated with silica gel 60 F254 as the stationary phase, while the solvent system was methanol. The Rf values were observed to be 0.5 ± 0.02, and 0.3 ± 0.02 for OND and RAN, respectively. The separated spots were densitometrically analyzed in absorbance mode at 299 nm. This method was linear in the range of 25-300 ng/band for OND and 50-600 ng/band for RAN. The limits of detection for OND and RAN were found to be 3.47 and 1.83 ng/band, respectively. The limits of quantification for OND and RAN were found to be 10.53 and 5.55 ng/band, respectively. The proposed method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of OND and RAN in combined dosage form.

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Novel Stability-Indicating High-Performance Thin Layer Chromatography (HPTLC) Method Development and Validation for Estimation of Daclatasvir Dihydrochloride in Pharmaceutical Dosage Form

Analytical Chemistry Letters ◽

10.1080/22297928.2020.1779812 ◽

2020 ◽

Vol 10 (3) ◽

pp. 402-413

Author(s):

Panchal Urvisha ◽

Parikh Nisha ◽

Shah Ragin ◽

Patwari Arpit

Keyword(s):

Thin Layer ◽

Thin Layer Chromatography ◽

High Performance ◽

Dosage Form ◽

Method Development ◽

Pharmaceutical Dosage Form ◽

Method Development And Validation ◽

Development And Validation ◽

Layer Chromatography ◽

Hptlc Method

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NOVEL RP-HPLC METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF TELMISARTAN AND NEBIVOLOL HCL IN PHARMACEUTICAL DOSAGE FORM

Asian Journal of Pharmaceutical and Clinical Research ◽

10.22159/ajpcr.2018.v11i9.27016 ◽

2018 ◽

Vol 11 (9) ◽

pp. 431 ◽

Cited By ~ 1

Author(s):

Heena Ar Shaikh ◽

Vandana Jain

Keyword(s):

High Performance ◽

Dosage Form ◽

Method Development ◽

Limit Of Detection ◽

Hplc Method ◽

Limit Of Quantification ◽

Pharmaceutical Dosage Form ◽

Rp Hplc ◽

Validation Parameters ◽

Hplc Method Development

Objective: A simple, accurate, precise, robust reverse phase high performance liquid chromatography (RP-HPLC) method was developed for the estimation of telmisartan and nebivolol hydrochloride (HCl) simultaneously in its combined dosage form.Methods: The compounds were well resolved in an isocratic method using the mobile phase composition of acetonitrile: Buffer (potassium dihydrogen orthophosphate pH adjusted 3.1 with orthophosphoric acid) in a ratio of 40:60 v/v at a flow rate of 1.2 ml/min using C18 Shim-pack (150 mm × 4.6 mm, 5 μ) column. The detection was carried out at 280 nm.Results: The retention time of telmisartan and nebivolol HCl was 4.8 min and 6.5 min, respectively. The developed method was validated by evaluating various validation parameters such as linearity, precision, accuracy, robustness, specificity, limit of detection, and limit of quantification according to the international council for harmonization guidelines. The standard calibration curve was obtained in the concentration range of 24–56 μg/ml for telmisartan and 3–7 μg/ml for nebivolol HCl. The overall average % recovery was found out to be 100.35 for telmisartan and 98.84 for nebivolol HCl.Conclusion: Statistical analysis of the data showed that the method is reproducible and selective for the estimation of telmisartan and nebivolol HCl. The proposed method could be used for analysis of telmisartan and nebivolol HCl in their dosage form.

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Fast Stability Indicating UPLC Method for Quantitative Analysis of Dronedarone in Pharmaceutical Dosage Form: Force Degradation Study

ISRN Chromatography ◽

10.1155/2014/962130 ◽

2014 ◽

Vol 2014 ◽

pp. 1-7

Author(s):

Batuk Dabhi ◽

Hetal Jebaliya ◽

Yashwantsinh Jadeja ◽

Madhavi Patel ◽

Anamik Shah ◽

...

Keyword(s):

Dosage Form ◽

Limit Of Detection ◽

Chemical Oxidation ◽

Pharmaceutical Dosage Form ◽

Degradation Study ◽

Stability Indicating ◽

Time Value ◽

Heat Degradation ◽

Significant Difference ◽

Alkali Hydrolysis

A simple, precise, rapid reproducible, selective, and stability indicating reverse phase UPLC method has been developed for the estimation of dronedarone in pharmaceutical dosage form. Estimation of dronedarone hydrochloride was achieved on Acquity BEH C18 (100 mm*2.1 mm) 1.7 μm column using buffer [20 mM KH2PO4 + 1 mL Triethylamine (pH=2.5 by orthophosphoric acid)] and methanol in ratio of 40 : 60 as mobile phase at 30°C. The flow rate was 0.4 mL/min and effluents were monitored at 290 nm. The method was validated with respect to linearity, accuracy, precision, LOD, LOQ, and robustness. The method was linear over the concentration range 0.38–90 μg/mL (r2=0.999), with a limit of detection and quantification of 0.1 and 0.38 μg/mL, respectively. Dronedarone was subjected to acid and alkali hydrolysis, chemical oxidation, dry heat degradation, and photo (sunlight) degradation. The degraded product peaks were well resolved from the drug peak with significant difference in their retention time value.

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Quantification of Newly Discovered Anti-Cancer Drug Enzalutamide in Bulk and Synthetic Mixture by Stability Indicating TLC Method

Current Drug Discovery Technologies ◽

10.2174/1570163814666171027120238 ◽

2019 ◽

Vol 16 (1) ◽

pp. 104-112

Author(s):

Dharmendra Jayantibhai Prajapati ◽

Usmangani Khalilurraheman Chhalotiya ◽

Minesh Dahyabhai Prajapati ◽

Jalpa Upendrabhai Patel ◽

Jaineel Vinodrai Desai

Keyword(s):

High Performance ◽

Limit Of Detection ◽

Linear Regression Analysis ◽

Analysis Data ◽

Solvent System ◽

Chemical Oxidation ◽

Synthetic Mixture ◽

Cancer Drug ◽

Limit Of Quantification ◽

Stability Indicating

Objective: An impressionable, discriminatory and precise stability indicating high performance thin layer chromatographic method has been developed and validated for the estimation of Enzalutamide in bulk and synthetic mixture. Method: The method engaged HPTLC aluminium plates pre-coated with silica gel 60F-254 as the stationary phase while the solvent system was ethyl acetate: toluene (4.5:5.5, v/v). The Rf value of enzalutamide was detected to be 0. 39 &#177; 0. 005 and the densitometric analysis was carried out in absorbance mode at 246 nm. The linear regression analysis data for the calibration plots presented a virtuous linear relationship for enzalutamide over a concentration range of 20 - 1000ng/band. Results: The limit of detection and limit of quantification for enzalutamide was found to be 9.05 and 27.43 ng/band. Enzalutamide was imperilled to acid and alkali hydrolysis, chemical oxidation, dry heat degradation and photolytic degradation. The degraded product peaks were well resolved from the pure drug peak with substantial difference in their Rf values. Conclusion: Stressed samples were assayed using developed TLC technique. Suggested method was validated with respect to linearity, accuracy, precision and robustness. The method was successfully applied to the estimation of enzalutamide in synthetic mixture.

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DEVELOPMENT OF A DENSITOMETRIC HIGH-PERFORMANCE THIN-LAYER CHROMATOGRAPHIC METHOD FOR THE QUANTITATIVE ANALYSIS OF URSOLIC ACID IN THE LEAVES OF SPECIES OF GENUS TECOMA AND TABEBUIA OF BIGNONIACEAE FAMILY

International Journal of Pharmacy and Pharmaceutical Sciences ◽

10.22159/ijpps.2017v9i2.15802 ◽

2017 ◽

Vol 9 (2) ◽

pp. 109

Author(s):

Kalyani A. Kedar ◽

Sanjay R. Chaudhari ◽

Avanapu S. Rao

Keyword(s):

Thin Layer ◽

Ursolic Acid ◽

High Performance ◽

Limit Of Detection ◽

Limit Of Quantification ◽

Average Percentage ◽

Ich Guidelines ◽

Tabebuia Rosea ◽

Hptlc Method ◽

Concentration Levels

Objective: A simple and sensitive high-performance thin–layer chromatographic (HPTLC) method was developed for the quantification of ursolic acid in the leaves of three species of genus Tecoma (Tecoma gaudichaudi DC, Tecoma capensis (Thunb.) Lindl, Tecoma stans (L.) Juss. ex Kunth) and genus Tabebuia (Tabebuia rosea Bertol) belong to family Bignoniaceae.Methods: Chromatography was performed on Silica gel 60 F254 precoated HPTLC Plates with optimised mobile phase pet ether: ethyl acetate: formic acid (7:3:0.5, v/v/v). The plate was derivatized with p-anisaldehyde reagent and scanned at 540 nm. The developed method was found to give a compact spot for ursolic acid at Rf value 0.43±0.01. The method was validated using International Council for Harmonization (ICH) guidelines, including linearity, precision, accuracy, and robustness.Results: Ursolic acid was found to be present in four species, i.e., Tecoma gaudichaudi DC (1.48%w/w), Tecoma capensis (Thunb.) Lindl. (0.79%w/w), Tecoma stans (L.) Juss. Ex Kunth (1.11%w/w), Tabebuia rosea (Bertol.) (1.13%w/w). A good linearity relationship was found to be (200-1400ng band−1) with a correlation coefficient (r2) value of 0.9946 with ursolic acid. Limit of detection and limit of quantification was considered to be 40.66, 123.21 ng per band respectively. The developed method was found to be accurate and precise with 1.32%, 1.19% (%RSD) for interday and intraday precision. The accuracy of the method was performed by recovery studies at three different concentration levels, and the average percentage recovery was found to be 98.05% for ursolic acid.Conclusion: The proposed method for the quantitation of ursolic acid was found to be reproducible and simple.

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