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 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 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.

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 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.

DEVELOPMENT AND VALIDATION OF NEW HPT LC METHOD FOR SIMULTANEOUS ESTIMATION OF RUPATIDINE FUMARATE AND MONTELUKAST SODIUM IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (06) ◽  
pp. 29-35
Author(s):  
T Raja ◽  
◽  
A. L Rao
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Dosage Form ◽  
Pharmaceutical Formulations ◽  
Solvent System ◽  
Simultaneous Estimation ◽  
Montelukast Sodium ◽  
Aluminum Plates ◽  
Tablet Dosage

A new simple high performance thin layer chromatographic method for simultaneous determination of rupatidine fumarate and montelukast sodium in bulk and tablet dosage form was investigated. Chromatographic separation of the drugs was performed on aluminum plates precoated with silica gel 60 F254 as the stationary phase and the solvent system consisted of acetone:methanol:toluene (2:3:5, V/V/V). Densitometric evaluation of the separated zones was performed at 286 nm and the method was validated. The Rf values and drug content of rupatidine fumarate and montelukast sodium were 0.57±0.02, 0.68±0.02 and 98.3%, 97.67% respectively. The calibration curves of peak area versus concentration, were linear from 50-300 ng per band for both rupatidine fumarate and montelukast sodium and the regression coefficient (r2 ) was greater than 0.99. The method was validated for linearity, accuracy, robustness and application for assay as per ICH guidelines. The study showed that the developed method was simple and accurate and would be suitable for the simultaneous determination of rupatidine fumarate and montelukast sodium in bulk and pharmaceutical formulations.

Sign in / Sign up

Export Citation Format

Share Document