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

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.

INDIAN DRUGS ◽  
2012 ◽  
Vol 49 (12) ◽  
pp. 51-55
Author(s):  
S Kathirvel ◽  
◽  
K. Madhu Babu

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.


2010 ◽  
Vol 93 (4) ◽  
pp. 1222-1227 ◽  
Author(s):  
Susheel John Varghese ◽  
Thengungal Kochupappy Ravi

Abstract This paper describes validated HPLC and HPTLC methods for the simultaneous determination of rosuvastatin (ROS) and ezetimibe (EZE) in a combined tablet dosage form. The isocratic RP-HPLC analysis was performed on a Chromolith C18 column (100 6 mm id) using 0.1 (v/v) orthophosphoric acid solution (pH 3.5)acetonitrile (63 + 37, v/v) mobile phase at a flow rate of 1 mL/min at ambient temperature. Quantification was carried out using a photodiode array UV detector at 245 nm over the concentration range of 0.510 g/mL for ROS and EZE. The HPTLC separation was carried out on an aluminum-backed sheet of silica gel 60F254 layers using n-butyl acetatechloroformglacial acetic acid (1 + 8 + 1, v/v/v) mobile phase. Quantification was achieved with UV densitometry at 245 nm over a concentration range of 0.10.9 g/spot for ROS and EZE. The analytical methods were validated according to International Conference on Harmonization guidelines. Low RSD values indicated good precision. Both methods were successfully applied for the analysis of the drugs in laboratory-prepared mixtures and commercial tablets. No chromatographic interference from the tablet excipients was found. These methods are simple, precise, and sensitive, and are applicable for simultaneous determination of ROS and EZE in pure powder and tablets.


2020 ◽  
Vol 103 (4) ◽  
pp. 966-971
Author(s):  
Aml A Emam ◽  
Ibrahim A Naguib ◽  
Eman S Hassan ◽  
Eglal A Abdelaleem

Abstract Background Felodipine is a calcium channel blocker used together with metoprolol succinate for treatment of hypertension. Objective Two chromatographic methods were developed for simultaneous determination of felodipine (FEL) and metoprolol succinate (MET), and their major metabolites, dehydrofelodipine and metoprolol acid, respectively. Methods The first method was RP-HPLC which comprised separation of the studied components by gradient elution using a Phenomenex C8 column and a mobile phase composed of water (adjusted to pH 3.5 with o-phosphoric acid)–acetonitrile – methanol (45:40:15, by volume) for the first 6 min and (30:60:10, by volume) for the next 4 min at a flow rate of 1 mL/min followed by UV detection of the eluted peaks at 225 nm. The second method was an HPTLC method where separation was achieved using a mobile phase consisting of toluene–ethyl acetate–methanol–ammonia–formic acid (10:5:2.5:0.3:0.1, by volume) and scanning of the separated bands at 225 nm. Results Validation of the developed methods was done according to ICH guidelines. Successful application of the developed methods was carried out for determination of the studied drugs in human spiked plasma and in Logimax® tablets. Conclusions The developed RP-HPLC and HPTLC methods can be further applied for quality control testing of the studied drugs. Highlights RP-HPLC and HPTLC methods for determination of FEL, MET and their major metabolites. The developed methods were successfully applied for determination of FEL and MET in Logimax® tablets.


2008 ◽  
Vol 5 (3) ◽  
pp. 427-430 ◽  
Author(s):  
V. Jagapathi Raju ◽  
J. V. L. N. Seshagiri Rao

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.


Author(s):  
T. S. Vishwas ◽  
B. M. Gurupadayya ◽  
Rupshee Jain

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.


2012 ◽  
Vol 2012 ◽  
pp. 1-4 ◽  
Author(s):  
Vivekkumar K. Redasani ◽  
Bhushan J. Mali ◽  
Sanjay J. Surana

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.


Author(s):  
CAROLINE GRACE A ◽  
PRABHA T ◽  
SIVAKUMAR T

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.


INDIAN DRUGS ◽  
2018 ◽  
Vol 55 (05) ◽  
pp. 37-41
Author(s):  
S. B Mishra ◽  
◽  
S Singh ◽  
A. Mukerjee

A simple, accurate and precise HPTLC method has been developed for the estimation of rutin from the aerial parts of Alhagi pseudalhagi (M. Bieb) Desv. The method employed silica gel 60 F254 precoated plates as stationary phase and a mixture of ethyl acetate: acetic acid: formic acid: water (10:1:1:1 v/v/v/v) as mobile phase. Densitometric scanning was performed at 366 nm after derivatizing the resolved peaks with anisaldehyde-sulphuric acid reagent. Beer’s law was obeyed in the concentration range of 400-1200ng/spot with regression equation for standard rutin as Y= 7.658x - 53.86 and r2=0.9885. The Retention factor for rutin is 0.39 ± 0.008. The % RSD (n=9) for interday, intraday precision and the recovery values were found to be 1.31% and 1.46% and 99.55-101.12%, respectively. The method was validated as per ICH Guidelines, proving its utility in estimation of rutin from the aerial parts of Alhagi pseudalhagi (M. Bieb) Desv.


2019 ◽  
Vol 15 (6) ◽  
pp. 635-641
Author(s):  
Nadia M. Mostafa ◽  
Ghada M. Elsayed ◽  
Nagiba Y. Hassan ◽  
Dina A. El Mously

Background:The concept of green analytical chemistry prevails due to the growing environmental pollution.Objective:Our attempts are to develop simple and eco-friendly method which is non-harmful to the environment by producing minimal waste. In this context, a green liquid chromatographic method was applied for the simultaneous determination of chlorpheniramine maleate, pseudoephedrine hydrochloride and propyphenazone in their combined dosage form.Methods:Separation was carried out using X select HSS RP C18 analytical column (250 × 4.6 mm, 5μm) using methanol - 0.02 M phosphate buffer pH 3 - triethylamine (60:40: 0.1, by volume) as a mobile phase. The separated peaks were detected at 215 nm at a flow rate 1.0 mL/min.Results:Quantification was done over the concentration ranges of 1-25 µg/mL for chlorpheniramine maleate, 5-35 µg/mL for pseudoephedrine hydrochloride and 10-120 µg/mL for propyphenazone. The suggested method was validated with regard to linearity, accuracy and precision according to the International Conference on Harmonization guidelines with good results.Conclusion:It could be used as a safer alternative for routine analysis of the mentioned drugs in quality control laboratories.


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