Validated HPTLC Method for the Estimation of Oxetacaine in Pharmaceutical Formulations

2021 ◽  
pp. 5668-5672
Author(s):  
Kavitha J ◽  
Bonda Vismitha ◽  
Kokilambigai KS ◽  
Seetharaman R ◽  
Lakshmi KS
Keyword(s):  
Mobile Phase ◽  
Glacial Acetic Acid ◽  
Current Method ◽  
Cost Effective ◽  
Pharmaceutical Formulations ◽  
Relieve Pain ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Chromatographic Resolution ◽  
Hptlc Method

Oxetacaine is a potent local anesthetics used to relieve pain associated with peptic ulcer. The current method details about a rapid, accurate and precise HPTLC technique for the assessment of Oxetacaine in Pharmaceutical formulation. Chromatographic resolution was carried out on precoated HPTLC plates (Silica gel 60 F254 on Aluminum plate) employing methanol: water: glacial acetic acid (8: 1.8: 0.2 v/v/v) as mobile phase. Densitometric assessment was carried out at 220nm [Camag TLC Scanner III with winCATs software (version – 1.3.4)]. The drug was identified with a Rf value of 0.61. The reliability of the projected method was ascertained by evaluating various validation parameters as per ICH guidelines. The proposed technique can evaluate ten or more formulation units concurrently in a single run and affords a more rapid and cost-effective QC tool for regular analysis of Oxetacaine in pharmaceutical formulations.

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 HPTLC-Densitometric Analysis of Eperisone Hydrochloride and Paracetamol in Their Combined Tablet Dosage Form

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Nirav Uchadadiya ◽  
Falgun Mehta ◽  
Pinak Sanchaniya
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Glacial Acetic Acid ◽  
Average Recovery ◽  
Form Identification ◽  
Ich Guidelines ◽  
Phase Calibration ◽  
Response Peak ◽  
Tablet Dosage ◽  
Hptlc Method

A simple, precise, accurate, and reliable HPTLC method has been developed and validated for the analysis of EPE-Eperisone hydrochloride and PCM-Paracetamol in their combined dosage form. Identification and analysis were performed on 100 mm × 100 mm layer thickness 0.2 mm, precoated silica gel G60-F254 aluminum sheet, prewashed with methanol, and dried in an oven at 50°C for 5 min. Toluene : methanol : ethyl acetate : glacial acetic acid (4 : 3.5 : 2.5 : 0.05) (v/v/v/v) was used as mobile phase. Calibration plots were established showing the dependence of response (peak area) on the amount chromatographed. The validated calibration ranges were 200–700 ng/spot and 1300–4550 ng/spot for EPE and PCM with correlation coefficient (R2) 0.994 and 0.996, respectively. Average % recovery was between 98.61–100.94% and 99.18–100.57% for EPE and PCM, respectively. The spots were scanned at 248 nm in a reflectance mode. The proposed method was validated as per ICH guidelines and successfully applied to the estimation of EPE and PCM in their combined tablet dosage form.

scholarly journals Influence of Different Chromatographic Conditions on the Level of Detection and Quantitation of Spironolactone by means of TLC-Densitometry

2019 ◽  
Vol 2019 ◽  
pp. 1-8 ◽  
Author(s):  
Małgorzata Dołowy
Keyword(s):  
Quality Control ◽  
Acetic Acid ◽  
Ethyl Acetate ◽  
Mobile Phase ◽  
Glacial Acetic Acid ◽  
Cost Effective ◽  
Pharmaceutical Formulations ◽  
The One ◽  
Tlc Analysis ◽  
Routine Quality Control

The aim of this study was to estimate the influence of different chromatographic conditions on the limits of detection and limits of quantitation (LODs and LOQs) of spironolactone by means of TLC-densitometry under different chromatographic conditions. A comparison of results obtained showed that the choice of appropriate chromatographic conditions for NP-TLC and RP-TLC analysis with densitometry could effectively decrease the LODs and LOQs of spironolactone. Of all chromatographic systems tested, the best was the one comprising chromatographic plates precoated with a mixture of silica gel 60, kieselguhr F254, and mobile phase A (n-hexane-ethyl acetate-glacial acetic acid, 24.5 : 24.5 : 1, v/v/v). The estimated average LOD and LOQ values were 0.034 and 0.103 μg/spot, respectively. This indicates that the described procedure is sufficiently sensitive for the identification and quantification of spironolactone alone. Thereby, the simple and cost-effective TLC-densitometric method can be utilized for the routine quality control of spironolactone in bulk drugs as well as in simple pharmaceutical formulations.

A Validated Green HPTLC Method for Quantitative Determination of Dapoxetine Hydrochloride and Tadalafil in Bulk and Pharmaceutical Formulations

2020 ◽  
Vol 58 (4) ◽  
pp. 303-308 ◽  
Author(s):  
Ibrahim A Naguib ◽  
Maimana A Magdy ◽  
Basma H Anwar ◽  
Nessreen S Abdelhamid
Keyword(s):  
Quality Control ◽  
Mobile Phase ◽  
High Performance ◽  
Raw Materials ◽  
Pharmaceutical Formulations ◽  
Uv Detector ◽  
Ich Guidelines ◽  
Hptlc Method ◽  
Dapoxetine Hydrochloride

Abstract Dapoxetine hydrochloride (DAP) and Tadalafil (TAD) were separated and determined quantitatively using a validated green high-performance thin layer chromatographic (HPTLC) method in their binary mixtures either as raw materials or in pharmaceutical formulations. The concentration ranges were 0.1–1.6 and 0.2–2.5 μg/band for dapoxetine and tadalafil, respectively, with accuracies of 98.93% ± 0.62 and 99.26% ± 1.39, respectively. Silica gel HPTLC F254 plates were used to carry out the separation. The mobile phase used was a mixture of ethanol–ethyl acetate (1:9 by volume), which is environmentally green and harmless. Densitometric scanning with UV detector was used to detect the separated peaks at 222 nm. ICH guidelines were followed to validate the suggested method, and the results prove that they can be used for regular analysis in quality control laboratories with compatible results.

RP-HPLC METHOD DEVELOPMENT FOR THE ASSAY OF AMPHOTERICIN B

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (02) ◽  
pp. 16-20
Author(s):  
L Mohankrishna ◽  
◽  
P. J. Reddy ◽  
B. P Reddy. ◽  
P. Navya
Keyword(s):  
Amphotericin B ◽  
Mobile Phase ◽  
Method Development ◽  
Pharmaceutical Formulations ◽  
Hplc Method ◽  
Ich Guidelines ◽  
Relative Standard ◽  
Phase Combination ◽  
Hplc Method Development

A sensitive and precise HPLC procedure has been developed for the assay of amphotericin B in bulk samples and pharmaceutical formulations by using a C18 column [Kromosil, C18, (5 µm, 4.6mm x 250 mm; Make. Waters)], and mobile phase combination is 1% formic acid in water and acetonitrile in ratio of 45:55 V/V. The procedure has been validated as per the ICH guidelines. The λmax of detection was fixed at 407 nm, so that there was less interference from mobile phase with highest sensitivity according to UV analysis. Calibration plots were linear in the range of 10-100 µg/mL and the LOD and LOQ were 0.02 µg/mL and 0.06 µg/mL respectively. The high recovery and low relative standard deviation confirm the suitability of the method for routine quality control determination of amphotericin B in different formulations.

DEVELOPMENT OF HPTLC METHOD FOR SIMULTANEOUS ESTIMATION OF CIPROFLOXACIN AND ORNIDAZOLE IN COMBINED DOSAGE FORM

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (05) ◽  
pp. 36-43
Author(s):  
N. R Dighade ◽  
◽  
M. D Shende ◽  
A. V Kasture
Keyword(s):  
Quality Control ◽  
High Resolution ◽  
Thin Layer ◽  
Mobile Phase ◽  
High Performance ◽  
Dosage Form ◽  
Simultaneous Estimation ◽  
Ich Guidelines ◽  
Hptlc Method ◽  
Routine Quality Control

A simple and accurate high performance thin layer chromatographic (HPLTC) method has been developed and validated as per ICH guidelines for estimations of Ciprofloxacin (CP) and Ornidazole (ORN) in combined dosage form. The mobile phase was acetonitrile: toluene: water and triethylamine (5.5:1.8:1.5:1.6 V/V) was found to be best which gave high resolution with Rf 0.16 and 0.84 for ciprofloxacin and ornidazole respectively. The linearity of ciprofloxacin and ornidazole was found to be in the range of 0.4 to 0.8 µg/mL and 0.4 to 0.8 µg/mL, respectively. The coefficient of correlation (r2 ) was found to be greater than 0.989 for both the components by this method. The tablet analyses result (n = 5) were found to be > 100.84 % by HPTLC for both the components. The proposed method was found to be simple, accurate and suitable for routine quality control of marketed formulations containing these drugs.

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

INDIAN DRUGS ◽  
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.

scholarly journals DETERMINATION OF CHROMATOGRAPHIC ASSAY AND VALIDATION OF OFLOXACIN IN BULK AND PHARMACEUTICAL DOSAGE FORM

2018 ◽  
Vol 11 ◽  
Author(s):  
Sumithra M
Keyword(s):  
Mobile Phase ◽  
Dosage Form ◽  
Chromatographic Method ◽  
Assay Method ◽  
Reverse Phase ◽  
Pharmaceutical Dosage Form ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
The Mean

Objective: The objective of the study is simple, sensitive; eco-friendly reverse phase chromatographic method has been developed and validated for the quantitative determination of ofloxacin in bulk and marketed formulation. Method: The developed method was done using Hypersil silica C18 (250 mm × 4.6 mm, 5 μ particle size) as column and the mobile phase is containing water and methanol in the ratio of (10:90) vol/vol. The mobile phase pass at 1 ml/min flow rate and the eluted solution is measured at 270 nm using a PDA detector. Results: The assay method is linear from the concentration range of 5–30 μg/ml. The corelation coefficient is 0.9998. The mean percentage recovery for the developed method is found to be in the range of 98.4–100.6%. The developed method complies robustness studies. Conclusion: The validation of the developed method was done by as per the ICH guidelines. It obeys the linearity, accuracy, precision, and robustness studies. Validation parameters are within the limitations. The results of the developed process indicated the reverse phase chromatographic method is simple, accurate as well as precise, rapid and eco-friendly method for routine analysis of ofloxacin in bulk and its pharmaceutical dosage form.

scholarly journals APPLICATION OF VALIDATED RP-HPLC METHOD FOR THE DETERMINATION OF ARMODAFINIL IN BULK AND FORMULATION

2017 ◽  
pp. 158-161
Author(s):  
Devi Ramesh ◽  
Mohammad Habibuddin
Keyword(s):  
Retention Time ◽  
Mobile Phase ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Reverse Phase ◽  
Rp Hplc ◽  
Ich Guidelines ◽  
Validation Parameters ◽  
Isocratic Mode

Objective: The objective of the present study is to develop and validate a simple, rapid, sensitive reverse phase HPLC method for the determination of Armodafinil present in bulk and its pharmaceutical formulations.Methods: The chromatographic separation was achieved by using Hypersil ODS C-18 (150 x 4.6 mm, 5µ) in an isocratic mode with mobile phase methanol: phosphate buffer 3.0 (60:40 %v/v) was used. The flow rate was 1 ml/min and effluent was monitored at 225 nm. The method was validated for validation parameters i.e. linearity, accuracy, precision and robustness according to ICH guidelines.Results: The retention time of Armodafinil was 4.2 min and the linearity range of the method was 500-20000ng/ml with regression (r2) coefficient 0.9998. The method was validated for precision, accuracy, robustness and which were found to be within the acceptable limits according to the ICH guidelines. Also, the method was successfully applied for the estimation of Armodafinil in the marketed formulation of Nuvigil and the recovery was found to be>98%.Conclusion: The developed method possess good selectivity, specificity, there is no interference found in the blank at a retention time of ARM and good correlation between the peak area and concentration of the drugs under prescribed conditions. Hence, the method can be applied for routine analysis of Armodafinil. 

scholarly journals Determination of Delafloxacin in Pharmaceutical Formulations Using a Green RP-HPTLC and NP-HPTLC Methods: A Comparative Study

Antibiotics ◽  
2020 ◽  
Vol 9 (6) ◽  
pp. 359 ◽  
Author(s):  
Prawez Alam ◽  
Essam Ezzeldin ◽  
Muzaffar Iqbal ◽  
Gamal A.E. Mostafa ◽  
Md. Khalid Anwer ◽  
...  
Keyword(s):  
Ethyl Acetate ◽  
Silica Gel ◽  
Solid Lipid Nanoparticles ◽  
Ternary Mixture ◽  
Mobile Phase ◽  
Pharmaceutical Formulations ◽  
Lipid Nanoparticles ◽  
Ammonia Solution ◽  
Hptlc Method

In this work; delafloxacin (DLFX) was determined using a validated green RP-HPTLC and NP-HPTLC methods in commercial tablets and in-house developed solid lipid nanoparticles (SLNs). RP-HPTLC determination of DLFX was performed using “RP-18 silica gel 60 F254S HPTLC plates”. However; NP-HPTLC estimation of DLFX was performed using “silica gel 60 F254S HPTLC plates”. For a green RP-HPTLC method; the ternary combination of ethanol:water:ammonia solution (5:4:2 v/v/v) was used as green mobile phase. However; for NP-HPTLC method; the ternary mixture of ethyl acetate: methanol: ammonia solution (5:4:2 v/v/v) was used as normal mobile phase. The analysis of DLFX was conducted in absorbance/reflectance mode of densitometry at λmax = 295 nm for both methods. RP-HPTLC method was found more accurate, precise, robust and sensitive for the analysis of DLFX compared with the NP-HPTLC method. The % assay of DLFX in commercial tablets and in-house developed SLNs was determined as 98.2 and 101.0%, respectively, using the green RP-HPTLC technique, however; the % assay of DLFX in commercial tablets and in-house developed SLNs was found to be 94.4 and 95.0%, respectively, using the NP-HPTLC method. Overall, the green RP-HPTLC method was found superior over the NP-HPTLC. Therefore, the proposed green RP-HPTLC method can be successfully applied for analysis of DLFX in commercial tablets, SLNs and other formulations containing DLFX.

Sign in / Sign up

Export Citation Format

Share Document