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

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 Safinamide Mesylate in Bulk and in Tablet Dosage Form

ISRN Analytical Chemistry ◽

10.5402/2012/135208 ◽

2012 ◽

Vol 2012 ◽

pp. 1-4 ◽

Cited By ~ 2

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.

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Development and Validation of HPTLC Method for Simultaneous Estimation of Emtricitabine, Rilpivirine and Tenofovir Disoproxil Fumarate in Combined Dosage form

Bangladesh Pharmaceutical Journal ◽

10.3329/bpj.v19i1.29247 ◽

2016 ◽

Vol 19 (1) ◽

pp. 114-121 ◽

Cited By ~ 3

Author(s):

J Saminathan ◽

T Vetrichelvan

Keyword(s):

Tenofovir Disoproxil Fumarate ◽

High Performance ◽

Dosage Form ◽

Pharmaceutical Journal ◽

Solvent System ◽

Simultaneous Estimation ◽

Relative Standard ◽

Aluminum Plates ◽

Development And Validation ◽

Hptlc Method

This study describes the development and validation of high performance thin layer chromatographic (HPTLC) method for the simultaneous estimation of Emtricitabine (EMT), Rilpivirine (RPV) and Tenofovir disoproxil fumarate (TFV) in combined dosage form. Chromatographic separation of these drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase using solvent system consisted of chloroform: ethyl acetate: methanol: glacial acetic acid (5:2:1:0.1 v/v/v/v). The densitometric analysis was carried out in absorbance mode at 272 nm. The drugs were satisfactorily resolved with Rf values of 0.28 ± 0.02, 0.70 ± 0.02 and 0.52 ± 0.04, respectively. The method was validated according to the International Conference of Harmonization (ICH) guidelines. The calibration curves were linear over the (r2 > 0.999) concentrations range from 600-2400 ng band-1 for Emtricitabine, 50-300 ng bands-1 for Rilpivirine and 600-3600 ng band-1 for Tenofovir disoproxil fumarate. The method showed accuracy of 100.01%, 100.32% and 100.14% and percentage assay of 99.91%, 98.72% and 99.34% for Emtricitabine, Rilpivirine and Tenofovir disoproxil fumarate, respectively. Percentage relative standard deviation (<2%) was found for both precision and robustness study showing that the proposed method was precise, specificity, robust and stable in accordance with ICH guidelines.Bangladesh Pharmaceutical Journal 19(1): 114-121, 2016

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

INDIAN DRUGS ◽

10.53879/id.53.10.10506 ◽

2016 ◽

Vol 53 (10) ◽

pp. 34-39

Author(s):

◽

Elakkiya L Shunmuganathan ◽

F. A Mehta ◽

U. K. Chhalotiya

Keyword(s):

Thin Layer ◽

High Performance ◽

Dosage Form ◽

Limit Of Detection ◽

Solvent System ◽

Chemical Oxidation ◽

Limit Of Quantification ◽

Pharmaceutical Dosage Form ◽

Significant Difference ◽

Hptlc Method

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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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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HIGH-PERFORMANCE THIN LAYER CHROMATOGRAPHIC METHOD FOR THE SIMULTANEOUS QUANTITATION OF LOPINAVIR AND RITONAVIR IN TABLET FORMULATION

INDIAN DRUGS ◽

10.53879/id.50.01.p0023 ◽

2013 ◽

Vol 50 (01) ◽

pp. 23-29

Author(s):

J. D. Fegade ◽

◽

N. D Chawla ◽

R. Y. Chaudhari ◽

V. R. Patil

Keyword(s):

Acetic Acid ◽

High Performance ◽

Chromatographic Method ◽

Glacial Acetic Acid ◽

Solvent System ◽

Tablet Formulation ◽

Ich Guidelines ◽

Rf Values ◽

Aluminum Plates ◽

Hptlc Method

The present work describes a simple, accurate and precise HPTLC method for simultaneous quantitation of ritonavir (RVR) and lopinavir (LVR) in tablet formulation. Chromatographic separation of both drugs was performed on precoated aluminum plates, silica gel 60 F254 as the stationary phase and the solvent system consisted of toluene: ethyl acetate: methanol: glacial acetic acid in the ratio of 6.5:2.5:0.5:0.5(v/v/v/v). Densitometric evaluation of the separated zones was performed at 266 nm. The two drugs were satisfactorily resolved with Rf values of 0.242 0.03 and 0.413 0.02 for RVR and LVR, respectively. The accuracy and reliability of the method was assessed by evaluation of linearity (400-2000 ng/spot for RVR and 1600-8000 ng/spot for LVR), precision (intra-day RSD 0.16-0.38% and inter-day RSD 0.21-0.60 % for RVR and intra-day RSD 0.35-0.58 % and inter-day RSD 0.26-0.55 % for LVR) and recovery (99.54 0.62 % for RVR and 100.45 0.65 % for LVR), in accordance with ICH guidelines.

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Development and Validation of HPTLC Method for Simultaneous Estimation of Resveratrol and Piperine in Its Pharmaceutical Dosage Form

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2021/v33i47a33062 ◽

2021 ◽

pp. 691-697

Author(s):

Ankita Gaikwad ◽

Madhuri Shelar ◽

Ganesh Andhale ◽

Jyoti Kadam

Keyword(s):

High Performance ◽

Limit Of Detection ◽

Pharmaceutical Preparation ◽

Simultaneous Estimation ◽

Limit Of Quantification ◽

Pharmaceutical Dosage Form ◽

Aging Properties ◽

Development And Validation ◽

Layer Chromatography ◽

Hptlc Method

Resveratrol is a plant compound that work as antioxidant and it also has anti-aging properties whereas Piperine is a alkaloid and it majorly used in spices. A HPTLC (High performance thin layer chromatography) study is conducted for estimation of Resveratrol and Piperine. The Mobile phase used was Chloroform: Ethyl Acetate (50:50 v/v). Rf Value of Resveratrol 0.59 and Piperine 0.79 was found. Stationary phase of Silica gel 60 F254 was used. Densitometric analysis was performed at 325 nm. The method was found to be linear. Recovery (ranging from 97% to 102.24 %), limit of detection (40.26 ng/spot, 1.64 ng/spot respectively for resveratrol & piperine), limit of quantification (122.02 ng/spot, 4.98 ng/spot respectively for resveratrol & piperine) and precision (≤ 2.00%) were found to be satisfactory. Validation performed with linearity, accuracy, precision, specificity, robustness, limit of detection and limit of quantification. Every parameter found within the range. The developed method allows to confirm that an accurate and reliable potency measurement of a pharmaceutical preparation can be performed.

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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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Development and validation of pimavanserin tartrate by normal phase- HPTLC method

International Journal of Pharmaceutical Chemistry and Analysis ◽

10.18231/j.ijpca.2021.015 ◽

2021 ◽

Vol 8 (2) ◽

pp. 75-78

Author(s):

Mohammad Mojeeb Gulzar Khan ◽

Pawar Vivek Laxman ◽

Abdul Talib ◽

Sandip Dinkar Firke ◽

Mohan G Kalaskar ◽

...

Keyword(s):

High Performance ◽

Limit Of Detection ◽

Pharmaceutical Formulations ◽

Normal Phase ◽

Limit Of Quantification ◽

Label Claim ◽

Development And Validation ◽

Layer Chromatography ◽

Hptlc Method

For the determination of pimvanserin tartrate in bulk and formulation, a rapid and simple High Performance Thin Layer Chromatography at 226 nm was developed and validated. The determination was carried out on thin coated aluminum backing plates covered with 200 mm layer of silica gel G 60 F254 (10×10 cm) plate as stationary phase and using a mobile phase of methanol: chloroform: trimethylamine (4:6:0.1 v/v/v) respectively. With a correlation coefficient (r) of 0.998, the development of pimvanserin tartrate was linear in the range of 0.7 to 4.2 µg/ml. The limit of detection (LOD) was found to be 7.68 ng/spot while the limit of quantification was found to be 23.28 ng/spot. The percentage label claim of pimvanserin tartrate in bulk and formulation was found to be 99 – 101 %. The percentage found in the formulation shows that no effect of excipient on drug. The conducted procedure has the benefit of being simple and quick. As a result, it can be used to examine pimvanserin tartrate in pharmaceutical formulations.

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Development and Validation of Stability Indicating Assay Method for Simultaneous Estimation of Glibenclamide and Metformin

International Journal of Pharmaceutical Quality Assurance ◽

10.25258/ijpqa.v8i03.9572 ◽

2017 ◽

Vol 8 (03) ◽

Author(s):

Waje M. K. ◽

Barge V. U. ◽

Talole B. B.

Keyword(s):

High Performance ◽

Dosage Form ◽

Limit Of Detection ◽

Assay Method ◽

Simultaneous Estimation ◽

Limit Of Quantification ◽

Chromatographic Procedure ◽

Development And Validation ◽

Tablet Dosage ◽

Liquid Chromatographic

A high performance reverse phase liquid chromatographic procedure is developed for simultaneous estimation of Metformin and Glibenclamide in combined tablet dosage form. The method was carried out on Agilent Hypersil ODS (4.6 x 250 mm) column with a mobile phase used consisting of Methanol: Water (0.1 % OPA) OPA= Ortho Phosphoric acid (80:20) and the pH of buffer was adjusted to 3 using 2M Orthophosphoric acid. The detection of the combined dosage form was carried out at 228 nm and a flow rate employed was 1 ml/min and column oven temperature at 300C. The retention times of Metformin andGlibenclamide were 3.4667 and 7.3500 minutes respectively. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification as per ICH norms. The proposed method can be used for the estimation of these combined drugs.

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Method Development and Validation of Spectrophotometric Methods for The Estimation of Rizatriptan Benzoate in Pure and Pharmaceutical Dosage Form

Research Journal of Pharmacy and Technology ◽

10.52711/0974-360x.2021.01043 ◽

2021 ◽

pp. 6003-6006

Author(s):

Pushpa Latha E. ◽

Sailaja B.

Keyword(s):

Dosage Form ◽

Method Development ◽

Limit Of Detection ◽

Limit Of Quantification ◽

Pharmaceutical Dosage Form ◽

Rizatriptan Benzoate ◽

Spectrophotometric Methods ◽

Ich Guidelines ◽

Development And Validation ◽

Tablet Dosage

Analytical UV derivative spectrophotometric method was developed and validated to quantify Rizatriptan Benzoate in pure drug and tablet dosage form. Based on the spectrophotometric characteristics of Rizatriptan Benzoate, a signal of zero (225nm), first (216nm), second (237nm), third (233nm), fourth (231nm) order derivative spectra were found to be adequate for quantification. The methods obeyed Beer's law in the concentration range of (0.1-360µg/ml) with square correlation coefficient (r2) of 0.999. The mean percentage recovery was found to be 100.01 ± 0.075. As per ICH guidelines the results of the analysis were validated in terms of linearity, precision, accuracy, limit of detection and limit of quantification, and were found to be satisfactory.

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