Development and Validation of Liquid Chromatographic Method for Naproxen and Esomeprazole in Binary Combination

Razzaq, Syed Naeem; Ashfaq, Muhammad; Khan, Islam Ullah; Mariam, Irfana

doi:10.4067/s0717-97072012000400024

Cited by 16 publications

(5 citation statements)

References 27 publications

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“…Reviewing the literature resulted in the occurrence of few methods for this FDC [22][23], however no stability indicating HPLC method was found for this FDC. We are involved recently to conduct research relating to method development of FDC of different drugs with varying chemical properties and many of these papers have been reported in the literature [24][25][26][27][28][29][30][31][32][33][34][35][36]. In order to fill this knowledge gap, it was attempted to develop and validate HPLC method with stability indicating properties for this FDC (ciprofloxacin and dexamethasone) not only in commercial formulations but also in human serum and urine.…”

Section: Preparation Of Human Urine Samplesmentioning

confidence: 99%

Stability Indicating Rp-HPLC Method for Simultaneous Determination of Ciprofloxacin and Dexamethasone in Binary Combination

Razzaq

Ashfaq

Mariam³

et al. 2017

J. Chil. Chem. Soc.

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A simple and isocratic HPLC method with stability indicating nature was developed and then subsequently validated for simultaneous determination of ciprofloxacin and dexamethasone in pharmaceutical formulations, human serum and urine. Best chromatographic separations were attained within run time of 10 minutes using C8 as stationary phase and mixture of phosphate buffer and methanol (41:59 v/v) as mobile phase. The mobile phase was flowed at 1.5 mL min -1 with detection of both the analytes at 270 nm using photodiode array detector. Validation of the method was accomplished using specificity, linearity, accuracy, precision, robustness, LOD and LOQ. The method was found linear from 3-21 mg mL -1 for ciprofloxacin (r 2 ≥ 0.999) and 1-7 mg mL -1 for dexamethasone (r 2 ≥ 0.999). The %age recoveries of ciprofloxacin in spiked human urine and serum were ≥99% and ≥85% respectively, while for dexamethasone they were ≥97% in both matrices. The method proficiently separated the peaks of ciprofloxacin and dexamethasone from all types of interfering substances including degradation products/impurities with purity index ≥ 0.9998. The method thus was stability-indicating and can be employed for simultaneous analysis of ciprofloxacin and dexamethasone in complex matrices involving multiple components in the mixture. 1-INTRODUCTION Ciprofloxacin(1-cyclopropyl-6-fluoro-4-oxo-7-(piperazin-1-yl)-quinoline-3-carboxylic acid), a well-known antibiotic, is used to relieve bacterial infections of the eyes, corneal ulcers along with some common bacterial attacks. Dexamethasone (8S,9R,10S,11S,13S,14S,1 6R,17R)-9-Fluoro-11,17-dihydroxy-17-(2-hydroxyacetyl)-10, 13,16-trimethyl-,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a] phenanthren-3-one [ Figure 1] also the enforcement agencies in general to monitor the quality of the marketed products. 2-EXPERIMENTAL Chemicals and ReagentsCiprofloxacin (99.87%) and dexamethasone (99.96%) reference standards were received from Schazoo Zaka Laboratories (Lahore, Pakistan) and were used as such without further refinement. Commercial products (Zoxan D and Ciprodex) containing 3 mg mL -1 ciprofloxacin and 1 mg mL -1 dexamethasone were analyzed during the current research work. All the chemicals used were of either HPLC grade or highest grade available commercially and were used as such. Double distilled water, other liquids used in mobile phase and all the injecting solutions were subject to filtration employing 0.45 mm nylon filters (Millipore, USA). Equipment and Chromatographic ConditionsAll the chromatographic work was conducted on LC-20A system (Shimadzu, Japan) using PDA detector at 270 nm. Each time 20 mL volume of analytes were injected using the fixed loop and peak areas of ciprofloxacin and dexamethasone were integrated using system built software. For separation, Hypersil BDS C8 column (250 X 4.6 mm, 5 mm) was used at room temperature. Pre-mixed mobile phase was used which was prepared by mixing 59:41 v/v ratio of methanol and 0.018M phosphate buffer (pH 3.0) and was flowe...

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Section: Preparation Of Human Urine Samplesmentioning

confidence: 99%

Stability Indicating Rp-HPLC Method for Simultaneous Determination of Ciprofloxacin and Dexamethasone in Binary Combination

Razzaq

Ashfaq

Mariam³

et al. 2017

J. Chil. Chem. Soc.

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“…RP-HPLC and UV methods have been widely used for estimation of drug in bulk and dosage forms (Prasanthi et al 2011;Shukla et al 2011;Basaveswara Rao et al 2012;Singh et al 2012;Banerjee and Vasava, 2013;Singh and Dahiya, 2014). Literature review also revealed that simultaneous analysis of naproxen and esomeprazole has been carried out by UVSpectrophotometer (Mahaparale et al 2013;Patel et al 2012;, RP-HPLC (Jain et al 2011;Deshpande et al 2014;Ampati et al 2014;Saravanan et al 2014;Razzaq et al 2012), stability indicating simultaneous estimation of naproxen and esomeprazole by RP-HPLC (Reddy et al 2011), LC-MS/MS (Gopinath et al 2013) and UPLC method (Rao et al 2013;Bhavyasri et al 2013). The present work describes simple, specific, rapid, accurate and precise chromatographic method based on RP-HPLC mechanism for estimation of drugs in tablet dosage form.…”

Section: Introductionmentioning

confidence: 99%

Development and Validation of New Analytical Method for the Simultaneous Estimation of Naproxen and Esomeprazole in Bulk and Pharmaceutical Formulation

Dm¹,

T²,

Sreedhar³

et al. 2016

BPR

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A new, simple, rapid, sensitive and inexpensive RP-HPLC method has been developed for the simultaneous estimation of naproxen and esomeprazole in bulk drug and pharmaceutical formulations. The method was validated for linearity, precision, accuracy, LOD and LOQ according to ICH guidelines. Chromatographic separation was achieved on Waters XBridge C18 column (250 × 4.6 mm, 5µ) using isocratic mobile phase 20 mM ammonium acetate (pH 3.8), acetonitrile and methanol (45:44:11 v/v) at 228 nm. The flow rate was 1ml/min. The retention time was observed at 3.69 min for esomeprazole and 6.6 min for naproxen. The standard curve was linear over the range of 2-12 µg/ml with the correlation coefficient of 0.9988 for esomeprazole and 0.995 for naproxen. The mean recoveries obtained for esomeprazole and naproxen were 100.06% and 99.8 to 100.01% respectively and RSD was less than 2%. Developed method was highly precise and convenient for routine analysis of naproxen and esomeprazole in bulk and tablet dosage forms.

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“…Efforts were therefore made to develop a novel, fast and validated stability indicating HPLC procedure for determining simultaneously both the drugs in pharmaceutical dosage forms and human serum. Currently we are developing analytical methods for drugs in binary combinations [16][17][18][19][20][21][22][23][24] and this study is a continuation of the previous work as it contained two active ingredients in formulation.…”

Section: Introductionmentioning

confidence: 99%

Stability-indicating RP-HPLC method for simultaneous determination of methoxsalen and p-aminobenzoic acid in binary combination

John¹,

Azeem²,

Ashfaq³

et al. 2015

Bull. Chem. Soc. Eth.

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ABSTRACT. An accurate, simple and specific reverse phase LC procedure is established and validated for simultaneous estimation of methoxsalen and p-aminobenzoic acid in pharmaceutical formulated products and human serum. Chromatographic separation among methoxsalen, p-aminobenzoic acid and their degradation products have been achieved in less than 5 min with Hypersil-ODS column (250 mm x 4.6 mm, 5 µm), using acetonitrile and 1.28 mM phosphate buffer as mobile phase (60:40 v/v). Flow rate of the mobile phase was set as 1.5 mL min -1 and detection of all the analytes was carried out by diode-array detector at 254 nm. The developed method was validated according to ICH guidelines by performing its linearity, accuracy, precision, specificity, robustness and LOD/LOQ values. Response was linear and proportional to the concentrations (24-48 µg mL -1 ) for p-aminobenzoic acid and (9-18 µg mL -1 ) for methoxsalen. The LOD was 2.3 ng mL -1 for p-aminobenzoic acid and 6 ng mL -1 for methoxsalen whereas LOQ was 7.8 ng mL -1 for p-aminobenzoic acid and 20.4 ng mL -1 for methoxsalen. The developed method efficiently separated the principal peaks from degradation products and therefore can be applied successfully for concurrent analysis of methoxsalen and p-aminobenzoic acid in pharmaceutical dosage form, human serum and product stability studies.

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Development and Validation of Liquid Chromatographic Method for Naproxen and Esomeprazole in Binary Combination

Cited by 16 publications

References 27 publications

Stability Indicating Rp-HPLC Method for Simultaneous Determination of Ciprofloxacin and Dexamethasone in Binary Combination

Stability Indicating Rp-HPLC Method for Simultaneous Determination of Ciprofloxacin and Dexamethasone in Binary Combination

Development and Validation of New Analytical Method for the Simultaneous Estimation of Naproxen and Esomeprazole in Bulk and Pharmaceutical Formulation

Stability-indicating RP-HPLC method for simultaneous determination of methoxsalen and p-aminobenzoic acid in binary combination

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