Journal of Pharmaceutical Research

A. B. Thomas ¹, A. A. Chaudhari ¹, R. K. Nanda ¹, L. P. Kothapalli ¹, U. B. Chavan ¹, A. D. Deshpande ¹

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

Abstract

Two spectrophotometric methods have been developed for the simultaneous estimation of Enalapril Maleate (Ena) and Losarton Potassium (Los) in combined tablet dosage forms. The first method involves determination using the absorbance correction method, the sampling wavelengths selected are, 222 nm and 250 nm over the concentration ranges of 2-32 mcg/mL and 1-60 mcg/mL for Ena and Los respectively. The second method is the second order derivative method, the sampling wavelength selected for estimation of Ena and Los are 219.5 nm and 264 nm which show linearity in the concentration ranges of 2-32 mcg/mL and 1-60 mcg/mL respectively. The results of the analysis were validated statistically and recovery studies were carried out as per ICH guidelines. Also the developed methods were successfully employed for dissolution studies in tablet dosage form.

Keywords

Enalapril, Losartan, Absorbance Correction Method, Second Order Derivative Method, Dissolution Studies.

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A. B. Thomas ¹, U. B. Chavan ¹, R. K. Nanda ¹, L. P. Kothapalli ¹, A. D. Deshpande ¹

Affiliations
1 Department of Pharmaceutical chemistry, Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune-411018, Maharashtra, IN

Abstract

Two UV spectrophotometric methods have been developed for the simultaneous estimation of Hydrochlorothiazide (Hctz), Atenolol (Atn) and Losartan Potassium (Los) in combined tablet dosage forms. The first method involves determination using the Area under curve, the sampling wavelength intervals selected are 274.5-270.5 nm, 226-222 nm and 252-248 nm over the concentration ranges of 0.5-30 mcg mL^-1, 1-50 mcg mL^-1 and 1-60 mcg mL^-1 for Hctz, Atn and Los respectively. The second method involves determination using the multicomponent mode of the UV visible spectrophotometer, the sampling wavelengths selected are 272.5 , 224 and 250 nm over the concentration ranges of 0.5-30 mcg mL^-1, 1-50 mcg mL^-1 and 1-60 mcg mL^-1 for Hctz, Atn and Los respectively. The results of the analysis were validated statistically and recovery studies were carried out as per ICH guidelines. The developed methods are simple, rapid, precise, accurate and can be employed for the routine estimation of Hydrochlorothiazide, Atenolol and Losartan Potassium in both bulk and tablet dosage form.

Keywords

Hydrochlorothiazide, Atenolol, Losartan Potassium, Area under Curve Method, Multicomponent Mode Method.

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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.

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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.

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A. B. Thomas ¹, S. D. Patil ¹, L. P. Kothapalli ¹, R. K. Nanda ¹, S. S. Bhosle ¹, A. D. Deshpande ¹

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

Abstract

Three UV spectrophotometric methods have been developed for the simultaneous estimation of Nateglinide (Nat) and Metformin hydrochloride (Met) in combined tablet dosage form. The first method is the Area under curve method, the sampling wavelength ranges selected for estimation of Nat and Met are 214-216 nm and 231-235 nm respectively with linearity in the concentration ranges of 0.5-80 μg /ml and 0.5-40 μg/ ml respectively. Second method involves determination using the Multicomponent mode of the UV visible spectrophotometer, the sampling wavelengths selected are 216 nm and 233nm over the concentration range 0.5-80 μg/ml and 0.5-40 μg/ml for Nat and Met respectively. The third method is the second order derivative method, the sampling wavelengths selected for estimation of Nat and Met are 225 nm and 234 nm with linearity in the concentration range 1-70 μg/ml and 1-40 μg/ml respectively. The results of the analysis were validated statistically and recovery studies were carried out as per ICH guidelines. The developed methods are simple, rapid, precise, accurate and can be employed for the routine estimation of Nateglinide and Metformin hydrochloride in both bulk and tablet dosage form.

Keywords

Nateglinide, Metformin Hydrochloride, Area under Curve Method, Multicomponent Mode, Second Order Derivative.

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