Validated HPTLC Method for Simultaneous Estimation of Levofloxacin Hemihydrate and Ornidazole in Pharmaceutical Dosage Form

Chepurwar, S. B.; Shirkhedkar, A.A.; Bari, Sanjay B.; Fursule, Ravindra A.; Surana, S. J.

doi:10.1093/chromsci/45.8.531

Cited by 19 publications

(8 citation statements)

References 10 publications

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“…It is available commercially in the form of tablets, creams etc. Various analytical methods have been developed for the pharmaceutical analysis of Ornidazole alone or in combination with other drugs using HPLC [1][2][3] , HPTLC [4][5][6] , GC 7 , Derivative spectroscopy [8][9][10][11] method of analysis etc.…”

Section: Quick Response Codementioning

confidence: 99%

Untitled

2016

IJPSR

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Combination drug formulations are better in terms of effectiveness and hence are used many times for treatment of diseases. The physico-chemical properties of the different API used in a formulation have a significant impact in the development of a single method for the analysis of such drugs. In the current research a rapid analytical method employing GC with Mass Spectroscopy detection has been developed and validated for simultaneous quantification of the active ingredients Ornidazole and Miconazole from the cream formulation. The analytes were extracted from cream base and filtered. A 95% dimethyl polysiloxane column with 5% phenyl polysiloxaneis used for the separation of the analytes. The method involves simple temperature gradient and MS detection. Validation of the method showed response was a linear function of concentration in the range 50-150 µg/mL for both Ornidazole and Miconazole. The method was suitably validated and was found to be precise and robust, with recoveries for both the analytes being consistent and complete. The method has been successfully applied for the analysis of samples from marketed cream formulations.

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Section: Quick Response Codementioning

confidence: 99%

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2016

IJPSR

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“…Literature survey revealed that few analytical methods are available for the individual estimation of levofloxacin by HPTLC [11][12] , by HPLC [13][14] and by conductometry 15 . Recently some UV spectrophotometric methods were reported for the estimation of levofloxacin using various solvent such as 0.1M HCl 16 , 100% methanol 17 , acetonitrile 18 and the mixer of water, methanol and acetonitrile 19 .…”

Section: Quick Response Codementioning

confidence: 99%

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2014

IJPSR

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The present study was undertaken to develop and validate a simple, accurate, precise, reproducible and cost effective UV-Visible spectrophotometric method for the estimation of levofloxacin in bulk and pharmaceutical formulation. The solvent used throughout the experiment was 0.1N NaOH. Absorption maximum (λ max) of the drug was found to be 288 nm. The quantitative determination of the drug was carried out at 288 nm and Beer's law was obeyed in the range of 2-12μg/mL. The method was shown linear in the mentioned concentrations having line equation y = 0.0704x + 0.0034 with correlation coefficient R 2 of 0.999. The recovery values for levofloxacin ranged from 99.92%-100.33%. The relative standard deviation of six replicates of assay was less than 2%.The percent relative standard deviation (RSD %) of interday precision range was 0.469-0.925 % and intraday precision range was 0.685-0.713%. The limit of detection and limit of quantification was 0.087μg/mL and 0.164μg/mL. The percent relative standard deviation of robustness and ruggedness of the method was 0.136-0.213%. Hence, proposed method was precise, accurate and cost effective. This method could be applicable for quantitative determination of the bulk drug as well as dosage formulation.

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“…As these drugs are frequently co-administered in various infections, an effective, simple and specific analytical method is required for simultaneous estimation, thereby it will be helpful in the quantification of drugs in the formulation as well as in the biological matrices. An extensive literature survey suggests that development of various analytical techniques such as ultraviolet (UV)-visible spectroscopy [1][2][3][4][5][6], HPLC [6][7][8][9][10][11][12][13][14][15][16][17][18][19][20][21][22][23][24], HPTLC [25][26][27][28] and LCMS [29][30][31][32] for quantification of these drugs either in individual or combination with other drugs. Recently, Krishna et al, [21] reported an RP-HPLC method with the help of sodium dihydrogen ortho-phosphate (pH-5.2): acetonitrile in the ratio of 70:30 (%v/v) as mobile phase.…”

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confidence: 99%

A Simple Liquid Chromatographic Method for Simultaneous Estimation of Azithromycin, Fluconazole and Ornidazole in Bulk and Pharmaceutical Dosage Forms

Narender

Kona²,

Muthyala³

et al. 2019

Int J Pharm Pharm Sci

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Objective: The objective of the study was to develop and validate a new rapid and more sensitive Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) method for the simultaneous estimation of azithromycin, fluconazole and ornidazole in bulk and pharmaceutical dosage forms. Methods: Separation was achieved with a cap cell pack C18 column (4.6 x 250 mm, 5μ) with an isocratic mobile phase containing a mixture of acetonitrile and phosphate buffer pH 4.8 [adjusted with ortho-phosphoric acid] (50:50 % v/v) at the flow rate of 1 ml/min and detection was monitored at 210 nm. Results: The retention time (Rt) of azithromycin, fluconazole and ornidazole were found to be 4.82±0.01, 5.25±0.01 and 6.33±0.01 min respectively. The precision was found with<1.5% of %RSD. The calibration curve was linear over the concentration ranging from 500-1000 µg/ml for azithromycin, 75-150 µg/ml for fluconazole and 375-750 µg/ml for ornidazole with the correlation coefficient (r2) of 0.999. The percentage recovery was found to be within the specified range i.e., 98-102 % for three drugs. Limit of detection (LOD) was found to be 5.810, 1.790 and 4.924 µg/ml, whereas Limit of quantification limits (LOQ) was found to be 9.834, 2.667 and 7.980 µg/ml, respectively. Conclusion: A simple isocratic liquid chromatographic method was developed and validated for simultaneous estimation of azithromycin, fluconazole and ornidazole in their formulations. Due to its simplicity, rapidness and specificity, it can be applied for routine quality control analysis of these drugs.

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Validated HPTLC Method for Simultaneous Estimation of Levofloxacin Hemihydrate and Ornidazole in Pharmaceutical Dosage Form

Cited by 19 publications

References 10 publications

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A Simple Liquid Chromatographic Method for Simultaneous Estimation of Azithromycin, Fluconazole and Ornidazole in Bulk and Pharmaceutical Dosage Forms

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