scholarly journals An eco-friendly HPLC-UV method for the determination of risedronate in its bulk and tablet dosage form with application to content uniformity, dissolution and stability testing

2020 ◽  
Vol 28 (11) ◽  
pp. 1301-1308
Author(s):  
Moustapha E. Moustapha ◽  
Mehnaz Kamal ◽  
Rania M. Elgamal
Keyword(s):  
Dosage Form ◽  
Content Uniformity ◽  
Stability Testing ◽  
Tablet Dosage

scholarly journals A method for content uniformity determination of atenolol and losartan potassium in combined tablet dosage form

2010 ◽  
Vol 72 (6) ◽  
pp. 792 ◽  
Author(s):  
RB Vyas ◽  
NR Maniyar ◽  
DR Shah ◽  
SA Shah ◽  
BA Vyas ◽  
...  
Keyword(s):  
Dosage Form ◽  
Losartan Potassium ◽  
Content Uniformity ◽  
Tablet Dosage

HPLC METHOD DEVELOPMENT FOR ESTIMATION OF RAMELTEON IN TABLET DOSAGE FORM

INDIAN DRUGS ◽  
2013 ◽  
Vol 50 (06) ◽  
pp. 20-23
Author(s):  
S Sahoo ◽  
◽  
P. K. Panda ◽  
S. K. Mishra
Keyword(s):  
Flow Rate ◽  
Dosage Form ◽  
Method Development ◽  
Hplc Method ◽  
Reverse Phase Hplc ◽  
Ich Guidelines ◽  
Hplc Method Development ◽  
Tablet Dosage ◽  
Good Agreement

A simple, fast, accurate and precise reverse phase HPLC method is developed and described for the determination of ramelteon in tablet dosage form. Chromatography was carried on an ODS column using a mixture of acetonitrile and phosphate buffer pH 7.0 (35:65 V/V) as the mobile phase at a flow rate of 1.0 mL/min with detection at 286 nm. The retention time of the drug was 7.7 min. The procedure was validated for linearity, precision, accuracy, and robustness. The developed method was validated for linearity from 50 to 150% which shows the method is quite linear with a correlation coefficient of 0.999, for precision which includes system precision, method precision, intraday and by another analyst on another day, and accuracy. The %RSD for system precision was observed to be 1.1, whereas the method precision was observed to be 0.2. The % recovery from ‘accuracy’ studies yielded the recovery of 99.7-101.5% which indicates the capability of the method, and finally for robustness that includes studies w.r.t. change in flow rate, the percentage of organic modifier and pH. As per ICH guidelines, method validation results are in good agreement. The proposed method was simple, sensitive, precise and accurate.

Stability Indicating Photodiode Array Detector Based Estimation of Dapagliflozin Propanediol Monohydrate in API and Tablet Dosage Form by RP-UPLC

2021 ◽  
pp. 4635-4639
Author(s):  
Ashok B. Patel ◽  
Ekta H. Vaghasiya ◽  
Amit R. Dudhatra ◽  
Amitkumar J. Vyas ◽  
Ajay I. Patel ◽  
...  
Keyword(s):  
Dosage Form ◽  
Active Pharmaceutical Ingredient ◽  
Array Detector ◽  
Column Temperature ◽  
Stability Indicating ◽  
Photodiode Array Detector ◽  
Acceptable Method ◽  
Photodiode Array ◽  
Tablet Dosage

Stability indicating RP-UPLC photo diode array detector based method for determination of Dapagliflozin propanediol monohydrate (DPM) in active pharmaceutical ingredient (API) and in tablet dosage form (5mg dapagliflozin) has been developed and validated on Bridge Ethylene Hybride (BEH) C18 column (50mm × 2.1 mm, 1.7µm). Mobile phase composition was water: acetonitrile (60:40 v/v), flow rate 0.5ml/min and detection carried out at 223nm at column temperature 30ºC. Chromatographic separation achieved within 2 min with retention time 0.77 min. Linearity of the method was found over the concentration range of 25-75µg/ml (R2 = 0.9977). The degradation was carried out in five different stress conditions. The developed method was able to resolve peak of API from all generated peaks. Sufficient degradation was achieved in the range of 5.25 to 12.31%. The peak purity is acceptable, Method validation was performed as per ICH guideline Q2(R1).

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.

scholarly journals DETERMINATION OF THIAMINE HCL (VITAMIN B1) AND PYRIDOXINE HCL (VITAMIN B6) CONTENT IN TABLET BY FTIR

2016 ◽  
Vol 8 (10) ◽  
pp. 257 ◽  
Author(s):  
Ilma Nugrahani ◽  
Citra Kartini
Keyword(s):  
Vitamin B6 ◽  
Dosage Form ◽  
Vitamin B1 ◽  
Area Under The Curve ◽  
Thiamine Hydrochloride ◽  
Compound Identification ◽  
Quantitation Limit ◽  
Validation Parameters ◽  
Tablet Dosage

<p><strong>Objective: </strong>The combination of thiamine hydrochloride (vitamin B1) with pyridoxine hydrochloride (vitamin B6) has been efficacious to help the metabolism of carbohydrates and amino acids. FTIR (Fourier transform infrared) is a technique widely used in compound identification and determination of functional groups but rarely used for the quantitative purposes. This study aims to obtain a analysis determination method of this vitamin combination simultaneously in tablet dosage form using FTIR.</p><p><strong>Methods: </strong>Amount of vitamin B1 and B6 standard were mixed with KBr crystal in a series of concentration (% w/w) in kalium bromide (kbr) crystal, then measured with FTIR. These spectrums yielded were transformed into an absorbance afterward changed to its derivative. The finest spectrum, which showed the best specificity and linearity, was selected and its area under the curve was calculated. The other validation parameters: accuracy, precision, detection limit, quantitation limit, and ranges, next were tested and determined. The validated method than was used to analyze the levels of vitamin B1 and B6 simultaneously in the tablets.</p><p><strong>Results: </strong>Vitamin B1 and B6 have the linear concentration range from 0.5 to 3.00% w/w. The regression equation for vitamin B1 is y = 0.0608 x-0.0176 with r = 0.9997 and Vx0 = 1.5047%, for vitamin B6: y = 0.0977 x+0.0079 r = 0.9995 and Vx0 = 1.7832%. Recovery results of vitamin B1: 98.98 to 100.93%, while B6: 99.06 to 100.43%. Intra-day and inter-day precision for vitamin B1: 1.73; 1.62; 1.48, and 0.58%, meanwhile for vitamin B6: 1.29; 1.60; 1.78, and 1.39%. The limits of detection and quantitation for vitamin B12 was 0.079 and 0.263% w/w respectively, and for vitamin B6, was: 0.093 and 0.311% w/w. The tablets from the market were tested showed the results that meet with compendia requirements.</p><p><strong>Conclusion: </strong>FTIR can be used for the determination of levels of vitamin B1 and B6 simultaneously in tablet dosage form and have met the validation requirements.</p>

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