Asian Journal of Research in Chemistry

Sagar B. Wankhede ¹, Vishal N. Borole ¹, Sohan S. Chitlange ¹

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

Abstract

Two simple, sensitive, rapid spectrophotometric methods have been developed for simultaneous estimation of diclofenac sodium (DFS) and omeprazole (OME) in capsules. First method involves solving simultaneous equations based on measurement of absorbance at two wavelengths 248.0 nm and 301.5 nm λ max of DFS and OME, respectively. Second method involves formation of Q-absorbance equation at 255.5 nm (isoabsorptive point) and 301.5 nm (λ max of OME). Beer's law was obeyed in the concentration range of 10-50 μg/ml and 5-25 μg/ml for DFS and OME, respectively. The methods were validated as per ICH guidelines. Statistical analysis proved that the methods were accurate, precise, and reproducible for analysis of DFS and OME in capsules. The wide linearity range, sensitivity, accuracy and simple procedure imply that the proposed technique demonstrated to be appropriate for routine analysis and quality control assay of capsules.

Keywords

Diclofenac Sodium, Omeprazole, Simultaneous Equation Method, Q-Absorbance Ratio Method.

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Sohan S. Chitlange ¹, Kaushalendra K. Chaturvedi ¹, Sneha R. Tawargeri ¹, Sagar B. Wankhede ¹

Affiliations
1 Padmashree Dr. D.Y. Patil Institute of Pharmaceutical Sciences and Research, Sant Tukaram Nagar, Pimpri, Pune-411018, Maharashtra, IN

Abstract

Rapid, accurate and sensitive method for simultaneous determination of salbutamol sulphate (SAL) and prednisolone (PRE) in pharmaceutical dosage form was developed in the present work. The first developed method wasArea under curve method, wavelength selected is232-222nm for salbutamol and 249-239nm for prednisolone respectively. Linearity was observed in concentration range of 6-20μg/ml for salbutamol as well as for prednisolone. Second developed method was high performance thin layer chromatography (HPTLC). The mobile phase selected was Ethyl acetate: Chloroform: methanol (6.0: 4.0:1.0 v/v/v) with UV detection at 230 nm. Retention factor for SAL and PRE were found to be 0.17 ± 0.02 and 0.52 ± 0.03 respectively. For HPTLC method, linearity was observed in the concentration range of 1-6μg/band for salbutamol and 2-6μg/band for prednisolone and drugs was subjected to oxidation, acid hydrolysis, base hydrolysis and sun light to apply stress condition for degradation studies. Results of analysis were validated statistically and by recovery studies.

Keywords

Salbutamol Sulphate, Prednisolone, Area under Curve Method, TLC-Densitometry and Degradation Studies.

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Sagar B. Wankhede ¹, Nitin R. Dixit ¹, Somnath S. Zambare ¹, Sohan S. Chitlange ¹

Affiliations
1 Padmashree Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Sant Tukaram Nagar, Pimpri, Pune-411018, Maharashtra, IN

Abstract

A simple, specific, accurate and precise reverse phase high performance liquid chromatographic method have been developed and validated for simultaneous determination of Atorvastatin calcium and Metoprolol succinate in capsules. Chromatography was carried out by gradient technique on a reversed-phase C-18 column (4.6 mm×250 mm, 5 μm) using acetonitrile-phosphate buffer (pH 3.5)-methanol (50:40:10, v/v/v) as a mobile phase at a flow rate of 1.0 ml/min and UV detection at 276 nm. The linearity of the calibration curves for each analyte in the desired concentration range was good (r²>0.99). The method was accurate and precise with recoveries in the range of 99.84% and 100.62% for both the drugs and relative standard deviation (R.S.D.)<2. The proposed method is highly sensitive, accurate and precise and hence was successfully applied for the reliable quantification of API content in the commercial formulation containing these drugs in combination. The different analytical performance parameters such as linearity, accuracy, precision, robustness, limit of detection (LOD) and limit of quantification (LOQ) were determined according to International Conference on Harmonization ICH Q2B guidelines.

Keywords

Atorvastatin Calcium, Metoprolol Succinate, RP-HPLC.

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Sohan S. Chitlange ¹, Ranjana Soni ¹, Sagar B. Wankhede ¹, Amol A. Kulkarni ¹

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

Abstract

Three simple spectrophotometric methods have been developed for simultaneous estimation of dexibuprofen and paracetamol from tablet dosage form. Ethanol (95%) was used as solvent. Method-I involves, formation of Q-absorbance equation at 235.5 nm (isoabsorptive point) and 249.5 nm (λ_max of paracetamol); Method-II simultaneous equation method involves the measurement of absorbances at two wavelengths 223 nm (λ_max of dexibuprofen) and 249.5 nm (λ_max of paracetamol) and Method-III multicomponent mode of analysis involves the measurement of absorbances at two wavelengths 223 nm (λ_max of dexibuprofen) and 249.5 nm (λ_max of paracetamol); The linearity lies between 2-7 μg/ml for dexibuprofen and 4-14 μg/ml for paracetamol for all the three methods. The accuracy and precision of the methods were determined and validated stastically. All the methods showed good reproducibility and recovery with % RSD less than 1. All method were found to be rapid, specific, precise and accurate and can be successfully applied for the routine analysis of dexibuprofen and paracetamol in bulk and combined dosage form.

Keywords

Dexibuprofen, Paracetamol, Q-Absorbance Ratio Method, Simultaneous Equation Method.

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