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Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms.
Pharmazie. 2008 Aug; 63(8):562-7.P

Abstract

A simple and rapid stability-indicating HPLC method was developed for determination of promethazine hydrochloride (PMZ) in hot-melt extruded (HME) films and sustained release tablets. Chromatographic separation was achieved on a 150 mm x 4.6 mm i.d., 3 microm particle size, C8 (2) column with acetonitrile-25mM phosphate buffer (pH 7.0), 50:50 (v/v) as mobile phase at a flow rate of 1 mL min(-1). Quantitation was achieved with UV detection at 249 nm based on peak area. The method was validated in terms of linearity, precision, accuracy, robustness specificity, limits of detection and quantitation according to ICH guidelines. Specificity was validated by subjecting the drug to acid, base, oxidative, reductive and dry heat degradations. None of the degradation products obtained by forced degradation interfered with the PMZ peak. The method was successfully applied for assessing the stability of the drug in the HME films and sustained release tablet formulations. In addition, uniformity of PMZ content in HME films was also determined using the method developed. Excipients present in either of the dosage forms analyzed did not interfere with the analysis indicating the specificity of the method. Due to its simplicity and accuracy, the method is suitable for application to various dosage forms.

Authors+Show Affiliations

Thumma S
Department of Pharmaceutics, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.
Zhang SQ
No affiliation info available
Repka MA
No affiliation info available

MeSH

Chromatography, High Pressure LiquidDosage FormsHistamine H1 AntagonistsHot TemperatureHydrogen-Ion ConcentrationHydrolysisOxidation-ReductionPromethazineReference StandardsReproducibility of ResultsSolubilitySpectrophotometry, Ultraviolet

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18771002

Citation

Thumma, S, et al. "Development and Validation of a HPLC Method for the Analysis of Promethazine Hydrochloride in Hot-melt Extruded Dosage Forms." Die Pharmazie, vol. 63, no. 8, 2008, pp. 562-7.
Thumma S, Zhang SQ, Repka MA. Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. Pharmazie. 2008;63(8):562-7.
Thumma, S., Zhang, S. Q., & Repka, M. A. (2008). Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. Die Pharmazie, 63(8), 562-7.
Thumma S, Zhang SQ, Repka MA. Development and Validation of a HPLC Method for the Analysis of Promethazine Hydrochloride in Hot-melt Extruded Dosage Forms. Pharmazie. 2008;63(8):562-7. PubMed PMID: 18771002.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Development and validation of a HPLC method for the analysis of promethazine hydrochloride in hot-melt extruded dosage forms. AU - Thumma,S, AU - Zhang,Shuang-Qing, AU - Repka,M A, PY - 2008/9/6/pubmed PY - 2008/9/26/medline PY - 2008/9/6/entrez SP - 562 EP - 7 JF - Die Pharmazie JO - Pharmazie VL - 63 IS - 8 N2 - A simple and rapid stability-indicating HPLC method was developed for determination of promethazine hydrochloride (PMZ) in hot-melt extruded (HME) films and sustained release tablets. Chromatographic separation was achieved on a 150 mm x 4.6 mm i.d., 3 microm particle size, C8 (2) column with acetonitrile-25mM phosphate buffer (pH 7.0), 50:50 (v/v) as mobile phase at a flow rate of 1 mL min(-1). Quantitation was achieved with UV detection at 249 nm based on peak area. The method was validated in terms of linearity, precision, accuracy, robustness specificity, limits of detection and quantitation according to ICH guidelines. Specificity was validated by subjecting the drug to acid, base, oxidative, reductive and dry heat degradations. None of the degradation products obtained by forced degradation interfered with the PMZ peak. The method was successfully applied for assessing the stability of the drug in the HME films and sustained release tablet formulations. In addition, uniformity of PMZ content in HME films was also determined using the method developed. Excipients present in either of the dosage forms analyzed did not interfere with the analysis indicating the specificity of the method. Due to its simplicity and accuracy, the method is suitable for application to various dosage forms. SN - 0031-7144 UR - https://www.unboundmedicine.com/medline/citation/18771002/Development_and_validation_of_a_HPLC_method_for_the_analysis_of_promethazine_hydrochloride_in_hot_melt_extruded_dosage_forms_ DB - PRIME DP - Unbound Medicine ER -