scholarly journals A VALIDATED STABILITY INDICATING ULTRA-PERFORMANCE LIQUID CHROMATOGRAPHIC METHOD FOR SIMULTANEOUS DETERMINATION OF METFORMIN HYDROCHLORIDE AND EMPAGLIFLOZIN IN BULK DRUG AND TABLET DOSAGE FORM

2017 ◽  
Vol 9 (3) ◽  
pp. 45 ◽  
Author(s):  
N. Madana Gopal ◽  
C. Sridhar
Keyword(s):  
Simultaneous Determination ◽  
Dosage Form ◽  
Accurate Method ◽  
Array Detector ◽  
Metformin Hydrochloride ◽  
Control Analysis ◽  
International Conference ◽  
Stability Indicating ◽  
Tablet Dosage

Objective: To develop a simple, precise, accurate, method was developed and validated for analysis of metformin hydrochloride (MET) and empagliflozin in (EMPA) in bulk and tablet dosage form.Methods: The method used a reverse phase column, dikma C18 (50×2.1 mm, 1.8 μ), a mobile phase comprising of phosphate buffer (pH-3): methanol (30:70 v/v) flow rate of 1.0 ml/min and a detection wavelength of 240 nm using a photodiode array detector. The proposed method was validated for various parameters like linearity, precision, accuracy, robustness, ruggedness, detection, quantification limits, stability studies, formulation analysis as per International Conference on Harmonization (ICH) guidelines.Results: The retention time was found to be 1.189 min and 1.712 min for MET and EMPA respectively. The proposed method was found to be having linearity in the concentration range of 500-2500 μg/ml for MET (r2=0.989) and 5-25 μg/ml for EMPA (r2=0.994), respectively. The mean % recoveries obtained were found to be 100.35-100.48% for MET and 99.80-101.30% for EMPA respectively. Stress testing which covered acid, base, peroxide, photolytic and thermal degradation was performed on under test to prove the specificity of the method and the degradation was achieved. The developed method has been statistically validated according to International Conference on Harmonization (ICH) guidelines.Conclusion: Thus, the proposed method can be successfully applied for the stability indicating the simultaneous determination of MET and EMPA in bulk and combined tablet dosage form and in the routine quality control analysis.

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).

VALIDATED STABILITY INDICATING SPECTROSCOPIC METHOD FOR ESTIMATION OF DEGRADATION BEHAVIOUR OF VALSARTAN AND HYDROCHLOROTHIAZIDE IN TABLET FORMULATION

INDIAN DRUGS ◽  
2021 ◽  
Vol 58 (11) ◽  
pp. 53-59
Author(s):  
Tukaram M. Kalyankar ◽  
◽  
Shital S. Dange ◽  
Shivraj B. Hambarde ◽  
Shailesh J. Wadher ◽  
...  
Keyword(s):  
Simultaneous Determination ◽  
Dosage Form ◽  
Spectroscopic Method ◽  
Stress Conditions ◽  
Spectrometric Method ◽  
Degradation Behaviour ◽  
Stability Indicating ◽  
Photolytic Degradation ◽  
Tablet Dosage

A simple, accurate and precise UV spectrometric method has been developed for the simultaneous determination of valsartan and hydrochlorothiazide in tablet dosage form. Spectra of valsartan and hydrochlorothiazide in methanol and water (50:50 V/V) show λ max at 250.0 nm and 271.4 nm, respectively. Valsartan and hydrochlorothiazide are subjected to various stress conditions like acid, alkali, thermal and photolytic degradation. Beer’s law was obeyed in concentration range of 4- 24 µg mL-1 for valsartan and 0.5-3 µg mL-1 for hydrochlorothiazide at their respective wavelengths. The proposed method was successfully applied to tablet dosage form for determination of both drugs. The percentage recovery of valsartan and hydrochlorothiazide were found to be 100.19 % and 99.51 %, respectively. A novel accurate and precise stability indicating spectroscopic method has been developed for estimation of valsartan and hydrochlorothiazide.

scholarly journals Simultaneous Determination of Paracetamol, Chlorzoxazone and Diclofenac Sodium in Tablet Dosage Form by High Performance Liquid Chromatography

2011 ◽  
Vol 8 (3) ◽  
pp. 1206-1211
Author(s):  
Madhukar A. Badgujar ◽  
Satish G. Pingale ◽  
Kiran V. Mangaonkar
Keyword(s):  
Simultaneous Determination ◽  
High Performance ◽  
Dosage Form ◽  
Diclofenac Sodium ◽  
High Performance Liquid Chromatographic ◽  
Control Analysis ◽  
Liquid Chromatographic Method ◽  
Tablet Dosage ◽  
Liquid Chromatographic

A simple, precise and rapid isocratic reverse phase high performance liquid chromatographic method was developed for the simultaneous determination of paracetamol, chlorzoxazone and diclofenac sodium from tablet dosage form. The chromatographic separation was performed on an inertsil C18column (250 mm × 4.6 mm i.d 5 µm particle size). Mobile phase consisted of a mixture of phosphate buffer (0.02 M KH2PO4, pH adjusted to 3.7 using orthophosphoric acid), acetonitrile and methanol in the ratio of (25: 25: 50) at a flow rate of 1.0 mL/min. The wavelength was set at 220 nm. The proposed method was validated for linearity, accuracy, precision, LOD and LOQ. The calibration was linear over the range of 50-150 µg/mL for paracetamol, 50-150 µg/mL for chlorzoxazone and 5-15 µg/mL for diclofenac sodium. The retention times were found as 2.8 min for paracetamol, 4.2 min for chlorzoxazone and 6.4 min for diclofenac sodium. The method can be easily adopted for quality control analysis.

scholarly journals Determination of Tadalafil in Pure Powder and Tablet Dosage Form by High-Performance Liquid Chromatography

2010 ◽  
Vol 93 (2) ◽  
pp. 516-522 ◽  
Author(s):  
Tushar G Barot ◽  
Popatbhai K Patel
Keyword(s):  
High Performance ◽  
Dosage Form ◽  
Degradation Products ◽  
Accurate Method ◽  
Array Detector ◽  
Photodiode Array Detector ◽  
Photodiode Array ◽  
Tablet Dosage ◽  
Isocratic Mode

Abstract A simple and accurate method to determine tadalafil (TAD) in pure powder and tablet dosage form was developed and validated using HPLC. The separation was achieved on an Xterra RP18 column (150 4.6 mm id, 3.5 m) in the isocratic mode using bufferacetonitrile (70 + 30, v/v), adjusted to pH 7.00 0.05 with triethylamine as the mobile phase at a flow rate of 1.0 mL/min. The photodiode array detector was set at 225 nm. Quantification was achieved over the concentration range of 50.7152.10 g/mL with mean recovery of 100.26 0.75. The method was validated and found to be simple, accurate, precise, and specific. The method was successfully applied for the determination of TAD in pure powder and tablet dosage form without interference from common excipients or degradation products.

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