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Development and Validatin of a Normal Phase HPTLC Method for Simultaneous Estimation of Cetirizine Hydrochloride and Phenylephrine Hydrochloride in Fixed Dose Combination Tablets

Development and Validatin of a Normal Phase HPTLC Method for Simultaneous Estimation of... Abstract:This paper presents the development and validation of a method for the simultaneous analysis of Cetirizine hydrochloride (CTZ) and Phenylephrine hydrochloride (PHE) using high performance thin-layer chromatography (HPTLC) with densitometric detection. Separation was performed on silica gel G 60F254 plates. The mobile phase is comprised of Toluene: Ethyl acetate: Methanol: Ammonia (5:2:3:0.4 v/v/v/v). Detection wavelength was 254 nm. The Rf values were 0.31 30 ± 0.05 and 0.49 ± 0.05 for PHE and CTZ, respectively. The linear regression analysis data for the calibration plots showed a good linear relationship with r2 ≥0.999 in the concentration range of 2–12 μg for both drugs. The method was validated for accuracy, precision, robustness, and specificity, limit of detection and limit of quantitation. Statistical analysis proves that the method is repeatable and selective for estimation of both the drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Analytical Chemistry Letters Taylor & Francis

Development and Validatin of a Normal Phase HPTLC Method for Simultaneous Estimation of Cetirizine Hydrochloride and Phenylephrine Hydrochloride in Fixed Dose Combination Tablets

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Development and Validatin of a Normal Phase HPTLC Method for Simultaneous Estimation of Cetirizine Hydrochloride and Phenylephrine Hydrochloride in Fixed Dose Combination Tablets

Abstract

Abstract:This paper presents the development and validation of a method for the simultaneous analysis of Cetirizine hydrochloride (CTZ) and Phenylephrine hydrochloride (PHE) using high performance thin-layer chromatography (HPTLC) with densitometric detection. Separation was performed on silica gel G 60F254 plates. The mobile phase is comprised of Toluene: Ethyl acetate: Methanol: Ammonia (5:2:3:0.4 v/v/v/v). Detection wavelength was 254 nm. The Rf values were 0.31...
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Publisher
Taylor & Francis
Copyright
© 2013 The Experimental Psychology Society
ISSN
2230-7532
eISSN
2229-7928
DOI
10.1080/22297928.2013.838432
Publisher site
See Article on Publisher Site

Abstract

Abstract:This paper presents the development and validation of a method for the simultaneous analysis of Cetirizine hydrochloride (CTZ) and Phenylephrine hydrochloride (PHE) using high performance thin-layer chromatography (HPTLC) with densitometric detection. Separation was performed on silica gel G 60F254 plates. The mobile phase is comprised of Toluene: Ethyl acetate: Methanol: Ammonia (5:2:3:0.4 v/v/v/v). Detection wavelength was 254 nm. The Rf values were 0.31 30 ± 0.05 and 0.49 ± 0.05 for PHE and CTZ, respectively. The linear regression analysis data for the calibration plots showed a good linear relationship with r2 ≥0.999 in the concentration range of 2–12 μg for both drugs. The method was validated for accuracy, precision, robustness, and specificity, limit of detection and limit of quantitation. Statistical analysis proves that the method is repeatable and selective for estimation of both the drugs. As the method could effectively separate the drug from its degradation products, it can be employed as a stability indicating method.

Journal

Analytical Chemistry Letters – Taylor & Francis

Published: May 4, 2013

Keywords: Phenylephrine hydrochloride and Cetrizine hydrochloride; HPTLC; Stability Indicating Method; Degradation

References

  • Government of India, Ministry of Health and Family Welfare; Published by The Indian Pharmacopoeia
  • Government of India, Ministry of Health and Family Welfare; Published by The Indian Pharmacopoeia
  • Sequential injection spectrophotometric determination of Phenylephrine hydrochloride in pharmaceutical preparations
  • Applications of derivative UV332 spectrophotometry for the determination of Cetirizine dihydrochloride in preparations
  • Spectrophotometric and high performance liquid chromatographic determination of Cetirizine dihydrochloride in pharmaceutical tablets
  • Development and validation of a RP-HPLC method for the determination of Chlorpheniramine maleate and Phenylephrine in pharmaceutical dosage form
  • Method development and validation for simultaneous determination of Ebastine and Phenylephrine hydrochloride in tablet formulation by RP-HPLC
  • Validation of method for simultaneous determination of Paracetamol and Phenylephrine in pharmaceutical formulation by reversed phase liquid chromatography
  • Simultaneous determination of Paracetamol, Phenylephrine hydrochloride, Oxolamine citrate and Chlorpheniramine maleate by HPLC in pharmaceutical dosage forms
  • Simultaneous estimation of Ambroxol hydrochloride and Cetirizine hydrochloride in tablet dosage form by RP-HPLC method
  • Determination and quantification of Cetirizine HCl in dosage formulations by RP-HPLC
  • Development and validation of a rapid RP-HPLC method for the determination of Cetirizine or Fexofenadine with Pseudoephedrine in binary pharmaceutical dosage forms
  • Determination of Cetirizine dihydrochloride, related impurities and preservatives in oral solution and tablet dosage forms using HPLC
  • Spectrophotometric and high performance liquid chromatographic determination of Cetirizine dihydrochloride in pharmaceutical tablets
  • Determination of Cetirizine in tablets and compounded capsules: comparative study between CE and HPLC
  • Fluorometric determination of Phenylephrine hydrochloride by liquid chromatography in human plasma
  • Simultaneous determination of Lignocaine hydrochloride and Phenylephrine hydrochloride by HPTLC
  • Stability indicating HPTLC method for the simultaneous determination of Pseudoephedrine and Cetirizine in pharmaceutical formulations
  • Development and validation of HPTLC method for simultaneous estimation of Cetirizine hydrochloride and Phenylpropanolamine hydrochloride in tablet dosage form
  • Stability indicating HPTLC method development and validation for estimation of Ambroxol hydrochloride and Cetirizine dihydrochloride in combine tablet dosage form
  • Simultaneous stability-indicating determination of Phenylephrine hydrochloride, Phenylpropanolamine hydrochloride, and Guaifenesin in dosage forms by reversed-phase paired-ion high-performance liquid chromatography
  • Development and validation of RP-HPLC method for simultaneous estimation of Cetirizine HCl and Phenylephrine HCl in combined dosage form
  • Simultaneous estimation of Phenylephrine hydrochloride, Paracetamol, Caffeine and Cetirizine dihydrochloride from tablet dosage form using RP-HPLC
  • Handbook of Chemometrics and Qualimetrics Part A