Journal of Pharmaceutical Research

A. B. Thomas ¹, S. B. Dighe ¹, L. P. Kothapalli ¹, R. K. Nanda ¹, S. N. Jagdale ¹, A. D. Deshpande ¹

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

Abstract

Three UV 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 Q-absorbance ratio method, the sampling wavelengths selected are, 315.0nm (isoabsorptive point) and 233.0 nm (lmax of Cef). The second method is the First order derivative method, the sampling wavelengths selected are 269.0 nm and 240.0 nm for estimation of Cef and Pot.clav. respectively. In both the methods, the linearity range for both Cef and Pot.clav. was in the concentration range of 1.5-50 μg mL^-1. The third method based on ratio derivative spectrophotometry, involves measurement of absorbances at the amplitudes in the first order derivative of the ratio spectra at 246.0 nm and 327.0 nm for Cef and Pot.clav. respectively over the concentration range of 2.5-50 μg mL^-1for both the drugs. The results of the analysis were validated statistically and recovery studies carried out as per ICH guidelines. The developed methods are rapid, precise, accurate, rugged and can be employed for the routine estimation of Cefpodoxime proxetil and Potassium clavulanate in both bulk and tablet dosage form.

Keywords

Cefpodoxime Proxetil, Potassium Clavulanate, Q-Absorbance Ratio Method, First Order Derivative Spectroscopy, Ratio Spectra Derivative Spectrophotometry.

Full Text

   

A. B. Thomas ¹, S. N. Jagdale ¹, R. K. Nanda ¹, L. P. Kothapalli ¹, A. D. Deshpande ¹

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

Abstract

Amlodipine besylate and Telmisartan are used in the treatment of hypertension. A simple, selective and stability indicating High-performance thin-layer chromatography method has been established for the simultaneous analysis of Amlodipine besylate and Telmisartan. The method uses aluminum-backed silica gel 60F₂₅₄ TLC plates as stationary phase with ethyl acetate: methanol: ammonia: glacial acetic acid [7.5:1.5:1.0:0.2 (v/v/v/v)] as mobile phase. Densitometric analysis was carried out in the absorbance mode at 226 nm. This system was found to give compact bands for Amlodipine besylate and Telmisartan with Rf values of 0.34±0.02 and 0.60±0.02 respectively. Linear relationships were obtained between response and amount of drug with high correlation coefficients (r²) in the range 500-6000 ng band^-1 for Amlodipine besylate (r²=0.9951) and 1000-8000 ng band^-1 for Telmisartan (r²= 0.9982). The method was validated for precision, accuracy and robustness as per ICH guidelines. Amlodipine besylate and Telmisartan were subjected to acid, base, oxidation, dry heat, wet heat and photo degradation studies. The degradation products obtained were well resolved from the pure drugs with significantly different Rf values. As the method could effectively separate the drugs from its degradation products, it can be used for stabilityindicating analysis.

Keywords

Amlodipilne Besylate, Telmisartan, HPTLC.

Full Text