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

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.

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A Validated Stability-Indicating RP-LC Method for the Simultaneous Determination of Amlodipine and Perindopril in Tablet Dosage Form and Their Stress Degradation Behavior Under ICH-Recommended Stress Conditions

Journal of AOAC International ◽

10.5740/jaoacint.11-010 ◽

2013 ◽

Vol 96 (4) ◽

pp. 751-757 ◽

Cited By ~ 15

Author(s):

Mehmet Gumustas ◽

Sibel A Ozkan

Keyword(s):

Simultaneous Determination ◽

Mobile Phase ◽

Dosage Form ◽

Degradation Products ◽

Stress Conditions ◽

Assay Method ◽

Pharmaceutical Dosage Form ◽

Stability Indicating ◽

Tablet Dosage

Abstract A stability-indicating RP-LC assay method was developed for the simultaneous determination of the cardiovascular drugs amlodipine and perindopril in the presence of degradation products generated from forced decomposition studies. The developed method is applicable for the determination of related substances in bulk drugs and simultaneous assay in a tablet pharmaceutical dosage form. Separation of the drugs and their degradation products was obtained using an RP Waters Spherisorb ODS1 column (250 × 4.6 mm id, 5 μm particle size) with the mobile phase acetonitrile–water (30 + 70, v/v) containing 15 mM phosphoric acid. The pH of the mobile phase was adjusted to 5.0. A flow rate of 1.2 mL/min was used for the separations, with detection at 215 nm. The chromatographic separation was performed at a column temperature of 45°C. Atenolol was chosen as the internal standard. Amlodipine and perindopril were exposed to thermal, photolytic, hydrolytic, and oxidative stress conditions, and the stressed samples were analyzed by the proposed method. Degradation studies showed that both compounds were degraded under these stress conditions. The method was found to be stability-indicating and can be used for the routine analysis of amlodipine and perindopril in the studied combined tablet dosage form.

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

International Journal of Applied Pharmaceutics ◽

10.22159/ijap.2017v9i3.17441 ◽

2017 ◽

Vol 9 (3) ◽

pp. 45 ◽

Cited By ~ 4

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.

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