Identification of a degradation product in stressed tablets of olmesartan medoxomil by the complementary use of HPLC hyphenated techniques

Murakami, Tomonori; Konno, Haruyoshi; Fukutsu, Naoto; Onodera, Michinobu; Ḱawasaki, Takao; Kusu, Fumiyo

doi:10.1016/j.jpba.2008.02.021

Cited by 45 publications

(36 citation statements)

References 18 publications

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“…This supposition can be confirmed through studies conducted by Murakami et al. 10 However, OL reference substance should be used to confirm this assumption.…”

Section: Resultsmentioning

confidence: 70%

“…However, methods for determination of this drug isolated in biological fluids (plasma and urine), such as LC coupled with fluorescence and tandem mass spectrometry, 2,[5][6][7] or combined with other drugs 8,9 have been reported. Different methods using LC for determination of this antihypertensive to indicate OLM stability have been reported, [10][11][12][13] but CE (Capillary Electrophoresis) has not been previously used for this purpose. CE has many advantages over LC with respect to separation efficiency, consumption of reagents and samples, analysis time and simplicity of instrumentation.…”

Section: Introductionmentioning

confidence: 99%

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Stability-indicating comparative methods using mekc and lc for determination of olmesartan medoxomil

et al. 2013

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Recebido em 24/2/12; aceito em 25/7/12; publicado na web em 11/12/12 A stability-indicating method using MEKC was validated for the analysis of olmesartan medoxomil in tablets. Successful separation was achieved using a fused silica capillary (40 cm x 50 μm i.d.); background electrolyte consisted of a combination of 10 mmol L -1 borate buffer and 5 mmol L -1 anionic detergent sodium dodecyl sulfate (95:5; v/v) pH 6.5; hydrodynamic mode at 50 mBar for 5 s; 25 kV separation voltage at 25 °C; and column temperature 25 °C with detection at 257 nm. The proposed method, validated following ICH guidelines, was applied to the determination of this antihypertensive with good results compared with an LC method.

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“…This supposition can be confirmed through studies conducted by Murakami et al. 10 However, OL reference substance should be used to confirm this assumption.…”

Section: Resultsmentioning

confidence: 70%

Section: Introductionmentioning

confidence: 99%

Stability-indicating comparative methods using mekc and lc for determination of olmesartan medoxomil

et al. 2013

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“…Olmesartan medoxomil (OLM) is an extensively used antihypertensive drug (1). By the action of aryl esterases, situated in both intestine and plasma, it gets quickly de-esterified upon oral administration in to an active metabolite, i.e., olmesartan (2).…”

Section: Introductionmentioning

confidence: 99%

Product Development Studies on Surface-Adsorbed Nanoemulsion of Olmesartan Medoxomil as a Capsular Dosage Form

2012

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Abstract. The present study aimed at development of capsular dosage form of surface-adsorbed nanoemulsion (NE) of olmesartan medoxomil (OLM) so as to overcome the limitations associated with handling of liquid NEs without affecting their pharmaceutical efficacy. Selection of oil, surfactant, and cosurfactant for construction of pseudoternary phase diagrams was made on the basis of solubility of drug in these excipients. Rationally selected NE formulations were evaluated for percentage transmittance, viscosity, refractive index, globule size, zeta potential, and polydispersity index (PDI). Formulation (F3) comprising of Capmul MCM® (10% v/v), Tween 80® (11.25% v/v), polyethylene glycol 400 (3.75% v/v), and double-distilled water (75% v/v) displayed highest percentage cumulative drug release (%CDR; 96.69± 1.841), least globule size (17.51±5.87 nm), low PDI (0.203±0.032), high zeta potential (−58.93±0.98 mV), and hence was selected as the optimized formulation. F3 was adsorbed over colloidal silicon dioxide (2 ml/400 mg) to produce free-flowing solid surface-adsorbed NE that presented a ready-to-fill capsule composition. Conversion of NE to surface-adsorbed NE and its reconstitution to NE did not affect the in vitro release profile of OLM as the similarity factor with respect to NE was found to be 66% and 73% respectively. The %CDR after 12 h for optimized NE, surface-adsorbed NE, and reconstituted NE was found to be 96.69±0.54, 96.07±1.76, and 94.78±1.57, respectively (p>0.05). The present study established capsulated surfaceadsorbed NE as a viable delivery system with the potential to overcome the handling limitations of NE.

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“…No stability indicating assay of OLM in bulk and solid dosage form could be traced in the literature. However, the method that identified the main degradation products obtained during short-time storage using the hyphenated techniques has been reported (15). This method described the storage of tablets at 40°C/75 % RH for 6 months and identification of the degradation product by complementary use of the HPLC hyphenated techniques (LC-IR, LC-NMR and LC-MS) without isolation or purification processes.…”

mentioning

confidence: 99%

“…R. N. Sharma and S. S. Pancholi: RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditions, Acta Pharm. 60 (2010) [13][14][15][16][17][18][19][20][21][22][23][24]. …”

mentioning

confidence: 99%

RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditions

Sharma¹,

Pancholi²

2010

Acta Pharmaceutica

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Stability can be defined as the capacity of a drug substance or drug product to sustain its identity, strength, quality, and purity throughout the retest or expiration period (1). Stability testing of an active substance or finished product provides evidence of the quality of a drug substance or drug product to remain acceptable up to the stated period under storage conditions stated on the label. The International Conference on Harmonization (ICH) guidelines Q1A (R2) require the use of a validated stability-indicating assay method (SIAM) for stability testing of a drug substance or product (2). It also empha- A simple, sensitive and precise RP-HPLC-DAD method was developed and validated for the determination of olmesartan medoxomil (AT-II receptor blocker) in the presence of its degradation products. Olmesartan medoxomil and all the degradation products were resolved on a C 18 column with the mobile phase composed of methanol, acetonitrile and water (60:15:25, V/V/V, pH 3.5 by orthophosphoric acid) at 260 nm using a photodiode array detector. The method was linear over the concentration range of 1-18 mg mL -1 and precise with RSD < 1 % in intra-and inter-day study. Excellent recoveries of 99.3 ± 0.9 to 100.8 ± 1.2 % proved the accuracy of the method. Developed method was specific, as indicated by chromatographic resolution > 2.0 for each peak and sensitive with LOD 0.03 mg mL -1 and LOQ 0.1 mg mL -1 . The method was used to study the drug degradation behavior under forced conditions. Four degradation products (DP-I, II, III, IV) were formed during the degradation study in 0.1 mol L -1 HCl whereas only DP-I, II and III were formed in water, 0.01 mol L -1 NaOH and 3 % H 2 O 2 . No significant thermal or photolytic degradation was observed in solid drug. The method was applied successfully for the assay of olmesartan medoxomil in the tablet dosage form.

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Identification of a degradation product in stressed tablets of olmesartan medoxomil by the complementary use of HPLC hyphenated techniques

Cited by 45 publications

References 18 publications

Stability-indicating comparative methods using mekc and lc for determination of olmesartan medoxomil

Stability-indicating comparative methods using mekc and lc for determination of olmesartan medoxomil

Product Development Studies on Surface-Adsorbed Nanoemulsion of Olmesartan Medoxomil as a Capsular Dosage Form

RP-HPLC-DAD method for determination of olmesartan medoxomil in bulk and tablets exposed to forced conditions

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