Simultaneous determination of lidocaine hydrochloride, hydrocortisone and nystatin in a pharmaceutical preparation by RP-LC

Pendela, Murali; Kahsay, Getu; Baekelandt, Isabel; Schepdael, Ann Van; Adams, Erwin

doi:10.1016/j.jpba.2011.06.028

Cited by 34 publications

(17 citation statements)

References 19 publications

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“…specification (minimum 85.0%) and no statistically difference was observed (Student's test, p < 0.05). In comparison to the method developed by Pendela et al ,9 this method uses isocratic elution. Moreover, it keeps selectivity for structurally related compounds of nystatin.…”

Section: Resultsmentioning

confidence: 99%

“…In fact, few LC methods have been described for the control of nystatin in pharmaceutical preparations: in a mouthwash in combination with lidocaine and hydrocortisone using a gradient method;9 in a commercial ointment for a stability study but with a rapid elution which does not take into account separation of the ‘other compound’ with relative high content (max 4.0%);10 in different pharmaceutical preparations 11…”

Section: Introductionmentioning

confidence: 99%

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Development and validation of three methods: liquid chromatography, flow injection analysis and UV spectrophotometry for the routine control of nystatin capsules

2014

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Objectives As an alternative to amphotericin B used for selective digestive decontamination, physicians asked the hospital pharmacy for the preparation of nystatin capsules 500 000 IU. Methods Three methods were considered for the routine control: liquid chromatography (LC), flow injection analysis (FIA) and ultraviolet (UV) spectrophotometry. An isocratic LC method with UV detection was developed. A Hypersil BDS C18 column (150 mm×4.6 mm, 5 mm) thermostated at 30°C was used as the stationary phase. The mobile phase was a mixture of 0.05 M ammonium acetate buffer pH 6.0 methanol (35:65, v/v). Flow rate was 1.0 mL/min and run time was 25 min. Detection was operated at 305 nm and spectra were registered between 190 and 400 nm. 10 mL were injected. FIA used LC equipment in which the stationary phase was replaced by a PEEK capillary (164 cm, 0.13 mm internal diameter) with water flow (1.0 mL/min; 25°C). 10 mL were injected. UV spectrophotometry used a double beam spectrophotometer set at 305 nm.Solutions of nystatin (reference and samples) were prepared in methanol for FIA and LC (0.36 mg/mL). For UV spectrophotometry, a subsequent dilution (1:50, v/v) with ammonium acetate buffer/methanol (50:50, v/v) was needed. Results The three methods were validated according to ICH guidelines. In the case of LC, ruggedness of the method was tested. Three batches of hospital preparations were analysed by each method. Conclusions For routine control, UV spectrophotometry or FIA would be the methods of choice (rapid, easy). The LC method could be used to perform stability studies.

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Section: Resultsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Development and validation of three methods: liquid chromatography, flow injection analysis and UV spectrophotometry for the routine control of nystatin capsules

2014

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“…However, modern chromatographic techniques such as high-performance liquid chromatography (HPLC) [8–12] and ultra-performance liquid chromatography (UPLC) [13] are preferentially employed for the determination of hydrocortisone in conventional pharmaceutical products such as tablets, creams, and injections. The different HPLC methods employ different chromatographic conditions including the use of complex and sometimes expensive solvent systems.…”

Section: Introductionmentioning

confidence: 99%

Novel HPLC Analysis of Hydrocortisone in Conventional and Controlled-Release Pharmaceutical Preparations

Adi-Dako

Bekoe

Ofori-Kwakye

et al. 2017

Journal of Pharmaceutics

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An isocratic sensitive and precise reverse phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the determination and quantification of hydrocortisone in controlled-release and conventional (tablets and injections) pharmaceutical preparations. Chromatographic separation was achieved on an ODS (C18), 5 μm, 4.6 × 150 mm, with an isocratic elution using a freshly prepared mobile phase of composition methanol : water : acetic acid (60 : 30 : 10, v/v/v) at a flow rate of 1.0 ml/min. The detection of the drug was successfully achieved at a wavelength of 254 nm. The retention time obtained for the drug was 2.26 min. The proposed method produced linear detectable responses in the concentration range of 0.02 to 0.4 mg/ml of hydrocortisone. High recoveries of 98–101% were attained at concentration levels of 80%, 100%, and 120%. The intraday and interday precision (RSD) were 0.19–0.55% and 0.33–0.71%, respectively. A comparison of hydrocortisone analyses data from the developed method and the official USP method showed no significant difference (p > 0.05) at a 95% confidence interval. The method was successfully applied to the determination and quantification of hydrocortisone in six controlled-release and fifteen conventional release pharmaceutical preparations.

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“…Liquid chromatography has been utilized for the estimation of LD. Examples of the reported LC methods are ultraperformance liquid chromatography (UPLC) [22], HPLC with amperometric detection [23], liquid chromatography-mass spectrometry (LC-MS/MS) [24], and HPLC with UV detection [25,26]. DC has several related substances and potential impurities that should be monitored.…”

Section: Introductionmentioning

confidence: 99%

Validated Selective HPLC-DAD Method for the Simultaneous Determination of Diclofenac Sodium and Lidocaine Hydrochloride in Presence of Four of Their Related Substances and Potential Impurities

Belal¹,

Bedair²,

Gazy³

et al. 2015

Acta Chromatographica

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Summary. This study presents a selective high-performance liquid chromatography (HPLC) with diode array detection (DAD) method for the simultaneous estimation of diclofenac sodium and lidocaine hydrochloride in presence of four of their related substances and potential impurities, namely, 2,6-dimethylaniline (DMA), 2,6-dichloroaniline (DCA), N-phenyl-2,6-dichloroaniline (PDCA), and N-chloroacetyl-N-phenyl-2,6-dichloroaniline (CPDCA). Some of these related substances are reported as degradation products as well. Effective chromatographic separation was achieved using Waters Symmetry C18 column, (3.9 × 150 mm, 5 μm particle size) with gradient elution of the mobile phase composed of 0.05 M orthophosphoric acid and acetonitrile. The gradient elution started with 5% (by volume) acetonitrile, ramped up linearly to 65% in 5 min then kept constant till the end of the run. The mobile phase was pumped at a flow rate of 1.5 mL min −1 . The multiple wavelength detector was set at 220 nm, and quantification of both drugs was based on measuring their peak areas. The retention times for lidocaine and diclofenac were about 5.5 and 9.5 min, respectively. The reliability and analytical performance of the proposed HPLC procedure were statistically validated with respect to system suitability, linearity, ranges, precision, accuracy, specificity, robustness, detection, and quantification limits. Calibration curves were linear in the ranges of 10-200 μg mL −1 for both drugs with correlation coefficients not less than 0.9998. The proposed method proved to be selective by resolution of the two drugs from their related substances and potential impurities. The validated HPLC method was successfully applied to the analysis of this binary mixture in the combined formulation (ampoules dosage form), and the assay results were favorably compared with a previously reported HPLC method. The proposed method made use of DAD as a tool for peak identity and purity confirmation.

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Simultaneous determination of lidocaine hydrochloride, hydrocortisone and nystatin in a pharmaceutical preparation by RP-LC

Cited by 34 publications

References 19 publications

Development and validation of three methods: liquid chromatography, flow injection analysis and UV spectrophotometry for the routine control of nystatin capsules

Development and validation of three methods: liquid chromatography, flow injection analysis and UV spectrophotometry for the routine control of nystatin capsules

Novel HPLC Analysis of Hydrocortisone in Conventional and Controlled-Release Pharmaceutical Preparations

Validated Selective HPLC-DAD Method for the Simultaneous Determination of Diclofenac Sodium and Lidocaine Hydrochloride in Presence of Four of Their Related Substances and Potential Impurities

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