Asian Journal of Research in Chemistry

R. K. Nanda ¹, S. E. Potawale ¹, V. V. Bhagwat ¹, S. C. Hamane ¹, R. S. Deshmukh ²

Affiliations
1 D.Y.Patil Pratishthan’s Padmashree Dr. D.Y.Patil Institute of Pharmaceutical, Sciences and Research, Pimpri, Pune-411018, IN
2 Sinhgad College of Pharmacy, Vadgaon, Pune-411041, IN

Abstract

A simple, precise, accurate and rapid HPLC method has been developed, and validated for the determination of Aspirin, Atorvastatin Calcium simultaneously, in combined dosage form. Acetonitrile: 0.02 M Phosphate buffer with pH 6.1 (50%:50% v/v) is used as the mobile phase, pH adjusted with Sodium Hydroxide (1% aqueous). Mobile phase was delivered at the flow rate of 1.0 ml/min., 239 nm is the detection wavelength for this study. The applicability of the method for simultaneous determination of Aspirin, Atorvastatin Calcium was verified by the determination of these compounds in marketed capsules. Results of the analysis were validated statistically, and by recovery studies. Linearity for Aspirin And Atorvastatin Calcium was in the range of 5-35 μg/ml and 1-7 μg/ml, respectively and reproducibility was found to be satisfactory. The % assay (Mean±S.D.) was found to be 99.33±0.501 and 101.4±0.18 for Aspirin and Atorvastatin Calcium respectively. The recovery and RSD values are within the limits given in ICH guide lines. Method development indicates the suitability of proposed method for the routine determination of these compounds in capsule dosage form. The proposed method can be successfully used to determine the drug contents of marketed formulation.

Keywords

RP-HPLC, Validation, Aspirin, Atorvastatin.

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R. K. Nanda ¹, V. V. Bhagwat ¹, S. E. Potawale ¹, S. C. Hamane ¹

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

Abstract

A new simple high performance thin layer chromatographic (HPTLC) method for simultaneous determination of Cefixime and Potassium Clavulanate combined tablet dosage form has been developed and validated. The separation was carried out on Merck aluminum plates precoated with silica gel 60 F₂₅₄, using Acetone: Water: Acetic acid 8:0.8:1.2 (v/v/v) as mobile phase. The separated spots were stained with Iodine vapors and scanned at 410 nm. The retention factor for Cefixime and Potassium Clavulanate were found to be 0.23±0.01 and 0.68±0.01. The method was validated with respect to linearity, accuracy, precision, robustness, in accordance with ICH guidelines. The calibration curve was found to be linear over a range of 0.5-3.0 μg per spot for Cefixime and 0.310-1.870 μg per spot for Potassium Clavulanate. The method has been successfully applied for the analysis of drugs in pharmaceutical formulation. The % assay (Mean±S.D.) was found to be 100.29±0.9933 for Cefixime and 100.95±1.005 for Potassium Clavulanate.

Keywords

Cefixime, Potassium Clavulanate, HPTLC, Tablet Dosage Form.

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R. K. Nanda ¹, S. E. Potawale ¹, V. V. Bhagwat ¹, S. C. Hamane ¹, R. S. Deshmukh ²

Affiliations
1 Dr. D. Y. Patil Institute of Pharmaceutical Sciences and Research, Pimpri, Pune-411018, IN
2 Sinhgad College of Pharmacy, Vadgaon, Pune-411041, IN

Abstract

A simple, precise and economical procedure for the simultaneous estimation of Aspirin and Atorvastatin Calcium in capsule formulation has been developed. The first method employs simultaneous equations (Method I) which involve absorbance measurement at 225.5 nm (λ max of Aspirin) and 246.0 (λ max of Atorvastatin Calcium). Second method involves absorbance ratio (Method II), which uses the ratio of absorbances measured at two selected wavelengths, one at isoabsorptive point (232.5 nm) and other being the max of one of the two compounds. Third method involves measurement of area under curve (AUC). For this method wavelength ranges were chosen between 223.5-227.5 nm and 244-248 nm for Aspirin and Atorvastatin Calcium respectively. Results of analysis for methods were tested and validated for various parameters according to ICH guidelines, hence can be adopted for the routine analysis of Aspirin and Atorvastatin Calcium in tablet dosage form.

Keywords

Aspirin, Atorvastatin Calcium, Simultaneous Equation Method, Absorbance Ratio Method, Area Under Curve Method.

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