Simultaneous Analysis of Losartan Potassium, Amlodipine Besylate, and Hydrochlorothiazide in Bulk and in Tablets by High-Performance Thin Layer Chromatography with UV-Absorption Densitometry.

Department of Pharmaceutical Analysis, SRM College of Pharmacy, SRM University, Tamilnadu, Kattankulathur 603 203, India.
Journal of analytical methods in chemistry 01/2012; 2012:108281. DOI: 10.1155/2012/108281
Source: PubMed

ABSTRACT A Simple high-performance thin layer chromatography (HPTLC) method for separation and quantitative analysis of losartan potassium, amlodipine, and hydrochlorothiazide in bulk and in pharmaceutical formulations has been established and validated. After extraction with methanol, sample and standard solutions were applied to silica gel plates and developed with chloroform : methanol : acetone : formic acid 7.5 : 1.3 : 0.5 : 0.03 (v/v/v/v) as mobile phase. Zones were scanned densitometrically at 254 nm. The R(f) values of amlodipine besylate, hydrochlorothiazide, and losartan potassium were 0.35, 0.57, and 0.74, respectively. Calibration plots were linear in the ranges 500-3000 ng per spot for losartan potassium, amlodipine and hydrochlorothiazide, the correlation coefficients, r, were 0.998, 0.998, and 0.999, respectively. The suitability of this method for quantitative determination of these compounds was by validation in accordance with the requirements of pharmaceutical regulatory standards. The method can be used for routine analysis of these drugs in bulk and in formulation.

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    ABSTRACT: Two simple, accurate, and sensitive methods were developed for the determination of netobimin in the presence of its degradation product. Method (A) was an HPLC method, performed on C18 column using acetonitrile/methanol/0.01 M potassium dihydrogen phosphate (56 : 14 : 30 by volume) as a mobile phase with a flow rate of 0.5 mL/min. Detection was performed at 254 nm. Method (B) was a TLC method, using silica gel 60 F(254) plates; the optimized mobile phase was toluene/methanol/chloroform/ammonium hydroxide (5 : 4 : 6 : 0.1 by volume). The spots were scanned densitometrically at 346 nm. Linearity ranges were 1-10 μg/mL for method (A) and 0.5-5 μg/band for method (B), and the mean percentage recoveries were 99.3 ± 0.7% and 99.7 ± 0.7% for methods (A) and (B), respectively. The proposed methods were found to be specific for netobimin in the presence of up to 90% of its degradation product. Statistical comparison between the results obtained by these methods and the manufacturer method was done, and no significance difference was obtained.
    Journal of analytical methods in chemistry. 01/2012; 2012:754650.
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    ABSTRACT: Amlodipine besylate is a calcium channel blocker which is used in treatment of hypertension alone or in combination with other antihypertensive drugs like angiotensin-II-receptor antagonists (ARA II) group (Losartan potassium and Valsartan) or in combination with anti hyperlipidemic agent like Atorvastatin calcium. RP-HPLC method was developed for the assay of these drugs. The method was performed by reversed phase high performance liquid chromatography using a mobile phase 0.01 M ammonium acetate buffer (pH 5.5): acetonitrile with detection at 240 nm on a spherical monomeric C18 column (250 mm×4.6 mm, 5 μm) at flow rate of 1.5 ml/min. The proposed method was validated in terms of linearity ranged between [(2-12, 10-60, 16-96, 4-24 μg/ml) corresponding levels of 20-120% w/w of the nominal analytical concentration] with linear regression equations were [{y = 64.627× – 3.6383 (r=0.9998),y=75.385× – 8.3856 (r=0.9997), y=64.492× – 25.981 (r=0.9998), y=70.964× – 28.505(r=0.9998}], accuracy [100.18 ± 1.38, 100.79 ± 0.59, 100.45 ± 0.58 and 100.8 ± 1.69%], precision [99.29, 99.33, 99.30 and 99.30%], limits of detection [0.03, 0.18, 0.15, 0.007 μg/ml] and limits of quantitation [0.1, 0.54, 0.45, 0.024 μg/ml] for Amlodipine besylate, Losartan potassium, Valsartan and Atorvastatin calcium respectively. Method validation was developed following the recommendations for analytical method validation of International Conference on Harmonization (ICH) and Food and Drug Administration (FDA) organizations.
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    Journal of Liquid Chromatography &amp Related Technologies 02/2012; 35(3):428-443. · 0.57 Impact Factor


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