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Transfer of TLC screening methods to quantitative HPTLC–densitometry methods for pharmaceutical products containing amlodipine besylate, cefpodoxime proxetil, cetirizine 2HCl, diclofenac sodium, efavirenz, mefenamic acid, and atovaquone + proguanil HCl

Zeng B., Gu Y., Sherma J.

Acta Chromatographica

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2019

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Vol. 31, no. 4

246--249

EN

Transfer of seven thin-layer chromatography (TLC) Global Pharma Health Fund E.V. Minilab protocols for screening counterfeit pharmaceutical products in the field to quantitative high-performance TLC (HPTLC)–densitometry methods was performed using a model process published previously. The developed and validated methods for tablets containing amlodipine besylate, cefpodoxime proxetil, cetirizine 2HCl, diclofenac sodium, efavirenz, mefenamic acid, and atovaquone + proguanil HCl involved the use of only relatively inexpensive and nontoxic solvents, Merck KGaA Premium Purity HPTLC silica gel 60 F254 plates, semi-automated sample and standard solution application with a CAMAG Linomat 4, and automated densitometry with a CAMAG Scanner 3 for detection, identification, and quantification. In addition, previously transferred HPTLC–densitometry methods for azithromycin and for cephalexin were used to analyze a new product of each drug to demonstrate the applicability of the methods.

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Stress degradation studies on cefpodoxime proxetil and development of a validated stability-indicating HPLC method

Patel G, Rajput S

Acta Chromatographica

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2011

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Vol. 23, no. 2

215--234

EN

A simple, sensitive, specific, precise, and stability-indicating high-performance liquid chromatographic (HPLC) method for determination of cefpodoxime proxetil as bulk drug and as pharmaceutical formulation was developed and validated as per the International Conference on Harmonization (ICH) guidelines. An isocratic separation was achieved using a Phenomenex Luna C18 (250 mm × 4.6 mm i.d., 5 μm particle size) column with a flow rate of 1 mL min-1 and a UV detector to monitor the eluate at 254 nm. The mobile phase consisted of acetonitrile and 50 mM ammonium acetate pH 6 (pH was adjusted with o-phosphoric acid) in the ratio of 45:55 (υ/υ). The linear regression analysis data for the calibration plots showed good linear relationship with r2 = 0.9998 in the working concentration range of 1–80 μg mL-1 The LOD and LOQ were 0.17 and 0.5 μg mL-1, respectively. The drug was subjected to acid and alkali hydrolysis, oxidation, dry heat, wet heat treatment, and photodegradation. The standard drug peaks were well resolved from the degradation products’ peaks with significantly different retention time (tR), and the resolution factor for cefpodoxime proxetil was found to be greater than 1.7. As the method could effectively measure the drug in the presence of all degradation products and excipients expected to be present in the formulation, it can be employed as a specific stability-indicating method. Moreover, the proposed HPLC method was utilized to investigate the kinetics of the acidic and oxidative degradation processes at different temperatures. An Arrhenius plot was constructed and the apparent pseudo-first-order rate constant, half-life and activation energy were calculated.

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New spectrophotometric method for determination of cefpodoxime protexil

Srinivasa Rao Y., Chowdary K. P. R., Seshagiri Rao J. V. L. N.

Chemia Analityczna

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2004

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Vol. 49, No. 1

111-116

EN

A simple spectrophotometric method for the determination of pure cefpodoxime proxetil and in its pharmaceutical formulations has been developed. It utilises the pink colour formation following the complexation of cefpodoxime proxetil with sodium metaperiodate and brucine. The maximum absorbance of the complex appears at 520 nm and the system obeys Beerís law in the concentration range: 5-30 mg mL-1. The proposed method is selective, simple and inexpensive for the quantitative determination of cefpodoxime proxetil. It has been statistically validated.

PL

Opracowano prostą metodę spektrofotometrycznego oznaczania cefpodoksymu w stanie wolnym i w postaciach leku. Metoda wykorzystuje powstający różowy kompleks cefpodoksymu z metanadjodancm sodu i bmcyną. Ten chromogen, posiadający maksimum absorpcji przy df. fali 520 nm, spełnia prawo Beera w zakresie stężeń 5-30 ugmL(-1). Metoda została zwalidowana statystycznie. Zaproponowana metoda pozwala na selektywne, proste i ekonomiczne, ilościowe oznaczanie cefpodoksymu.