Spectrophotometric determination of hydrocortisone, nystatin and oxytetracycline in synthetic and pharmaceutical preparations based on various univariate and multivariate methods

Gallego, Jorge; Arroyo, J. Pérez

doi:10.1016/s0003-2670(02)00138-1

Cited by 54 publications

(25 citation statements)

References 33 publications

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“…The slit width was Various methods are available for the analysis of the two drugs in the literature separately; hydrocortisone; UV-spectrophotometer 10 , HPLC [11][12][13][14] , TLC 13 and LC-MS/MS 15 ; clotrimazole; UV-spectrophotometer 16 , Titration 17 , HPLC & TLC 13 . However, there is no report on analytical methods for the determination of hydrocortisone and clotrimazole simultaneously and that resolve the degradation products from the parent drugs.…”

Section: Instrumentation and Chromatographic Conditionmentioning

confidence: 99%

Development and Validation of HPTLC Assay Method for Simultaneous Quantification of Hydrocortisone and Clotrimazole in Cream and Applying for Stability Indicating Test

Genete

Hymete

Bekhit

2012

J. Chil. Chem. Soc.

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A simple, specific, precise and accurate simultaneous high-performance thin-layer chromatographic method of analysis for hydrocortisone and clotrimazole was developed and validated. The method employed HPTLC glass plates (20x10) mm precoated with silica gel 60 F 254 as the stationary phase. The solvent system consisted of Toluene: Propanol: Ammonia (13:3:0.1v/v) that gave compact spots with R f value of 0.27 ± 0.01 and 0.58 ± 0.02 for hydrocortisone and clotrimazole, respectively. Densitometric analysis of hydrocortisone and clotrimazole was carried out in the absorbance/reflectance mode at 226nm. The calibration curves showed good linear relationship with R 2 = 0.996 + 0.003 and 0.996 + 0.002 in the concentration range of 200-1200 and 200-1000 ng/µl for hydrocortisone and clotrimazole, respectively. The method was validated for precision, recovery and robustness. The LOD & LOQ were found to be 35.31, 107.01 and 34.93, 105.87 ng/µl for hydrocortisone and clotrimazole respectively. Statistical analysis proved that the method is repeatable, specific and accurate for the estimation of the studied drugs. Resolution of hydrocortisone, clotrimazole and their degradation products formed under different stress conditions (acid-base hydrolysis, oxidation and thermal degradation) was successfully achieved with the developed method indicating that it can be employed as a stability indicating method. Hydrocortisone (cortisol);11,17,20-dione, the main physiologic glucocorticoid in humans has an anti-inflammatory and an immunosuppressive effect besides its role on carbohydrate and protein metabolism 1-3 . The anti-inflammatory effect of hydrocortisone is due to reduction of histamine release, reduction of IgG production and decreasing of the activity of neutrophils and macrophages [4][5][6]imidazole is an imidazole derivative with antimycotic activity that is known to inhibit cytochrome P-450, ergosterol biosynthesis, and proliferation of cells and to interfere with cellular Ca 2+ homeostasis 7-9 . BACKGROUND

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Section: Instrumentation and Chromatographic Conditionmentioning

confidence: 99%

Development and Validation of HPTLC Assay Method for Simultaneous Quantification of Hydrocortisone and Clotrimazole in Cream and Applying for Stability Indicating Test

Genete

Hymete

Bekhit

2012

J. Chil. Chem. Soc.

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“…The official methods involve determination of AB [4] and GF [5] using potentiometer for pure drug but method has not been described for formulation. Some procedures have been described for the assay of either LS or AB or GF in single dosage forms [4][5][6][7]. AB, GF and LS mixture is not yet official in any pharmacopoeia but few formulations are available in generic market.…”

Section: Ambroxol Hcl (Ab) Chemically Known As Trans-4-(2-amino-35-dmentioning

confidence: 99%

Section: Ambroxol Hcl (Ab) Chemically Known As Trans-4-(2-amino-35-dmentioning

confidence: 99%

“…Under computer-controlled instrumentation, derivative spectrophotemetry is playing a very important role in the multicomponent analysis of mixtures by ultravioletvisible molecular absorption spectrophotometry [7]. Ternary mixtures can be easily resolved by means of a spectrophotometric method, which is based on the simultaneous use of "zero-crossing" and "ratio spectra derivative" methods [7][8]. The aim of this work is to investigate the utility of derivative spectrophotometry and to develop reliable spectrophotometric procedures for the simultaneous determination of AB, GF and LS either in laboratory samples, or in commercial dosage forms without any prior separation of individual drugs.…”

Section: Ambroxol Hcl (Ab) Chemically Known As Trans-4-(2-amino-35-dmentioning

confidence: 99%

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Simultaneous Determination of Ambroxol, Guaiphenesin and Levosalbutamol Sulphate in Pharmaceutical Formulations With the Use of Four Rapid Derivative Spectrophotometric Methods

Gagandeep¹,

Gill²,

Karan³

et al. 2012

J. Chil. Chem. Soc.

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Four simple, rapid, accurate, precise, reliable and economical spectrophotometric methods have been proposed for simultaneous determination of ambroxol, guaiphenesin and levosalbutamol sulphate, in pure and pharmaceutical formulations without any prior separation or purification step. The methods are first derivative zero crossing spectrophotometry, simultaneous equation, derivative ratio spectra zero crossing and double divisor ratio spectra derivative method. Developed methods show best results in terms of linearity, accuracy, precision, LOD and LOQ for standard laboratory mixtures of pure drugs and marketed formulations. Common excipients and additives did not interfere in determinations of these APIs. Results obtained by the proposed methods have been statistically compared by means of student t-test.

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“…A similar approach is used in pharmaceutical formulation. In practice, it often proves easier since the substances usually display a different UV spectrum [46,47].…”

Section: Process Analytical Techniques/process Analysismentioning

confidence: 99%

New Developments in Chemical Engineering for the Production of Drug Substances

Behr

Brehme

Ewers³

et al. 2004

Engineering in Life Sciences

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The pharmaceutical industry is moving towards a profitability gap between increasing costs and decreasing prices. Finally, management has understood that mergers and acquisitions, high throughput screening, and biotechnology alone will not save the companies' earnings. Therefore, classical approaches like the optimization of production technologies for drug substances, that might help to increase profitability, are receiving increasing attention. This paper shows how the combination of innovative components will guide the way to very efficient and cost-effective production. The first component is the design and manufacturing of production facilities. The second component is a process streamlining of the production process. The key technologies discussed here are process control and miniplant technology. For these technologies a brief outlook on future trends is given.

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Spectrophotometric determination of hydrocortisone, nystatin and oxytetracycline in synthetic and pharmaceutical preparations based on various univariate and multivariate methods

Cited by 54 publications

References 33 publications

Development and Validation of HPTLC Assay Method for Simultaneous Quantification of Hydrocortisone and Clotrimazole in Cream and Applying for Stability Indicating Test

Development and Validation of HPTLC Assay Method for Simultaneous Quantification of Hydrocortisone and Clotrimazole in Cream and Applying for Stability Indicating Test

Simultaneous Determination of Ambroxol, Guaiphenesin and Levosalbutamol Sulphate in Pharmaceutical Formulations With the Use of Four Rapid Derivative Spectrophotometric Methods

New Developments in Chemical Engineering for the Production of Drug Substances

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