Asian Journal of Research in Chemistry

Asha B. Thomas ¹, Shweta B. Dighe ¹, Rabindra K. Nanda ¹, Avinash D. Deshpande ¹

Affiliations
1 Department of Pharmaceutical Chemistry, Dr. D.Y.Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune-411 018, IN

Abstract

Three simple, precise, accurate and reproducible spectrophotometric methods have been developed for the simultaneous estimation of Cefpodoxime proxetil (Cef) and Potassium clavulanate (Pot.clav.) in combined tablet dosage forms. The first method involves determination using the simultaneous equation method, the sampling wavelengths selected are 233.0 nm and 312.0 nm for Cef and Pot.clav. respectively. The second method involves determination using the multicomponent mode of the UV visible spectrophotometer, the sampling wavelengths selected are 233.0 nm and 312.0 nm for Cef and Pot.clav. respectively. The third method involves determination using the Area under curve, the sampling wavelength intervals selected are 235.0-231.0 nm and 314.0-310.0 nm for Cef and Pot.clav. respectively. All the methods were found linear in the concentration range of 1.5-50 μg/ml for both Cef and Pot.clav. The results of the analysis were validated statistically and recovery studies were carried out as per ICH guidelines.

Keywords

Cefpodoxime Proxetil, Potassium Clavulanate, Simultaneous Equation Method, Multicomponent Mode of Analysis, Area under Curve Method.

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Lata P. Kothapalli ¹, Rahul R. Shahane ¹, Rabindra K. Nanda ¹, Asha B. Thomas ¹

Affiliations
1 Department of Pharmaceutical Chemistry, Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune 18, Maharashtra, IN

Abstract

A high-performance thin-layer chromatographic method was developed and validated for simultaneous determination of Domperidone maleate (DOM) and Naproxen Sodium (NAP) in combined dosage formulation. The chromatography was performed on pre-coated silica gel 60 F 254 plates using Toluene: Dichloromethane: Ethyl acetate: GAA (5:3:2:0.1 v/v/v/v) as mobile phase. Densitometric evaluation of the chromatograph was performed at 272 nm. The two drugs were satisfactorily resolved with Rf values 0.12 ± 0.02 and 0.70 ± 0.03 for DOM and NAP, respectively. The accuracy and reliability of the method was assessed by studying linearity for DOM (10-60 ng/band) and for NAP (250-1500 ng/band), presicion and accuracy and specificity, in accordance with ICH guidelines. The method determined the two drugs simultaneously from dosage forms without any interference of the tablet excipients. DOM and NAP were also subjected to acid, base, oxidation, heat and photo-degradation studies. The degradation products obtained were well resolved from the pure drugs when subjected to acid and alkali degradation and oxidative stress. The developed method could effectively separate the drugs from its degradation products and hence can be used as a stability-indicating assay.

Keywords

Domperidone Maleate, Naproxen Sodium, High Performance Thin Layer Chromatography, Forced Degradation, Validation.

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