Development and Validation of RP-HPLC Method for Simultaneous Estimation of Levocloperastine Fendizoate and Chlorpheniramine Maleate in their Combined Dosage Form

Meshram, Dhananjay

doi:10.26420/austinjanalpharmchemg.2017.1083

Cited by 2 publications

(1 citation statement)

References 6 publications

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“…These organic chemical solvents such as methanol, ethanol, dichloro methane, toluene, and benzene were utilized in Levocloperastine Fendizoate synthetic preparation. Levocloperastine Fendizoate (LCF), that is, 1-{2-[(4-chloro-phenyl)-phenylmethoxy]-ethyl}-piperidine [6] is a drug with a central antitussive effect and it is also endowed with an antihistaminic (sharing an ethylamine moiety with H1 receptor antagonists) and papaverine like activity similar to codeine, but without its narcotic effects [7][8][9][10]. The structural information of Levocloperastine Fendizoate and five organic volatile impurities (OVI) is shown in Figs.…”

Section: Introductionmentioning

confidence: 99%

Determination and Simultaneously Quantification of Five Organic Volatile Impurities Using Head Space Gas Chromatography in Levocloperastine Fendizoate Active Pharmaceutical Ingredients and Dosage Forms

Vidyamani,

RAMACHANDRAN

2023

Asian J Pharm Clin Res

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Objectives: Organic chemical solvents are generally used during drug material synthesis, excipients, as well as in the drug product formulation. They are not acceptable in the finished product. Hence, the main objective of our work is development and validation of rapid, sensitive, and selective head space gas chromatography (GC-HS) method for the determination of five organic volatile impurities (OVI) (methanol, ethanol, dichloromethane, toluene, and benzene) in Levocloperastine Fendizoate active pharmaceutical ingredient (API) and commercial syrups. Methods: The method was developed using a thermal gradient elution program associated with a column having dimensions are ZB-624, 30 m × 0.53 mm × 3.0 μm with a flow rate of 3.0 mL/min and Nitrogen (N2) as a carrier gas. A flame ionization detector was used as a detector, and its temperature is at 250°C whereas the injector temperature is at 225°C. The total run time is 25.0 min. Results: The newly developed GC-HS method was validated by its specificity and selectivity system precision, and method precision, limit of detection and limit of quantification, linearity, accuracy, robustness, ruggedness, and solution stability as per International Council for Harmonization (ICH). Quantization limits for five impurities were 210 ppm for methanol, 350 ppm for ethanol, 42 ppm for dichloromethane, 62 ppm for toluene, and 0.4 ppm for benzene. Correlation coefficient values of linearity were higher than 0.995 for five OVI. The mean recoveries of five impurities were between 90% and 110%. Conclusion: We found good and accepted results as per ICH guidelines for all validated parameters for five OVI. Thus, the developed GC-HS method was suitable for the separation and quantification of five OVI in Levocloperastine Fendizoate API and commercial syrups at present.

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Section: Introductionmentioning

confidence: 99%

Determination and Simultaneously Quantification of Five Organic Volatile Impurities Using Head Space Gas Chromatography in Levocloperastine Fendizoate Active Pharmaceutical Ingredients and Dosage Forms

Vidyamani,

RAMACHANDRAN

2023

Asian J Pharm Clin Res

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Assessment of the greenness of micellar HPLC method for rapid separation and simultaneous estimation of chlorpheniramine maleate in presence of some co-administered drugs in three pharmaceutical dosage forms using single run

Nasr

Soliman

Mohamed

et al. 2021

AChrom

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Sustainable chemistry established one of kind standards to maintain protection of environment through using safer mobile phase composition and/or lower solvent consumption. A fast green micellar HPLC method was developed and applied for the first time aiming at simultaneous determination of chlorpheniramine maleate, one of the most widely used antihistamine in combination with levochlopersatine fenodizoate or dextromethorphan hydrobromide or dexamethasone, in their pure forms, laboratory prepared mixtures and pharmaceutical dosage forms used in alleviating the symptoms of cough resulting from common colds and allergy. The separation was achieved on Kinetex C18 column (100 mm × 4.6 mm i.d., 2.6-μm particle size) using micellar aqueous mobile phase consisting of (30 mM sodium dodecyl sulfate and 50 mM sodium dihydrogen phosphate, pH 5) and ethanol (85:15) with UV detection at 230 nm. The four drugs were successfully separated using isocratic elution in a single run not exceeding 7 min. According to ICH guidelines, the method was confirmed to be linear, accurate and precise over the concentration ranges of 5–60 μg mL−1 for chlorpheniramine maleate, 10–100 μg mL−1 for levocloperastine fenodizoate and dextromethorphan hydrobromide and 5–30 μg mL−1 for dexamethasone. In addition, the greenness of the developed method was assessed using two different tools indicating their least hazardous effect on the environment.

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Development and Validation of RP-HPLC Method for Simultaneous Estimation of Levocloperastine Fendizoate and Chlorpheniramine Maleate in their Combined Dosage Form

Cited by 2 publications

References 6 publications

Determination and Simultaneously Quantification of Five Organic Volatile Impurities Using Head Space Gas Chromatography in Levocloperastine Fendizoate Active Pharmaceutical Ingredients and Dosage Forms

Determination and Simultaneously Quantification of Five Organic Volatile Impurities Using Head Space Gas Chromatography in Levocloperastine Fendizoate Active Pharmaceutical Ingredients and Dosage Forms

Assessment of the greenness of micellar HPLC method for rapid separation and simultaneous estimation of chlorpheniramine maleate in presence of some co-administered drugs in three pharmaceutical dosage forms using single run

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