Asian Journal of Pharmaceutical Analysis

Paras Virani ¹, Kinjal Dungrani ²

Affiliations
1 Shree Dhanvantary Pharmacy College, Kim. Surat, IN
2 Globela Pharma Private Limited. Surat, IN

Abstract

A simple, rapid and precise ultraviolet spectroscopy method was developed and validated for quantitative analysis of irbesartan in bulk drug. It is an angiotensin II receptor (AT1 subtype) antagonist. It is used for the treatment of hypertension. It shows maximum absorbance at 246 nm. Beer Lambert's was obeyed in the concentration range of in the range of 5-30 μg/ml. The method was successfully validated in accordance to USP pharmacopeia and ICH guideline for accuracy, precision, rang and linearity. The linear regression analysis data for calibration plots showed good linear relationship and obtain correlation factor is greater than 0.999 for irbesartan. The % Recovery/Accuracy was within the range between 98% and 102%. The percentage RSD for precision was found to be less than 2%. Thus method was successfully applied for routine analysis of irbesartan in bulk samples.

Keywords

Accuracy, ICH Guideline, Irbesartan, Precision, Validation, Ultraviolet Spectroscopy USP Pharmacopeia.

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Paras Virani ¹, Rajanit Sojitra ², Hasumati Raj ², Vineet Jain ²

Affiliations
1 Gujarat Technological University, Gujarat, IN
2 Quality Assurance Department, Shree Dhanvantary Pharmacy College, Kim, Surat, IN

Abstract

Atorvastatin is the most efficacious of the currently available HMG-CoA Reductase inhibitors used in antilipidemic and also used in athresclerosis, stroke, cardiac risk. The clinical and pharmaceutical analysis of this drug requires effective analytical procedures for quality control and pharmacodynamic and pharmacokinetic studies as well as stability study. An extensive survey of the literature published in various analytical and pharmaceutical chemistry related journals has been conducted and the instrumental analytical methods which were developed and used for determination as single or combination with other drugs in bulk drugs, formulations and biological fluids have been reviewed. This review covers the most recent many analytical methods including spectrophotometric methods, chromatographic method including HPLC, HPTLC and RP HPLC, liquid chromatography tendam mass spectroscopy were reported.

Keywords

Atorvastatin, Analytical Method, HPLC, Hmg-Coa Reductase Inhibitors, Antilipidemic.

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Paras Virani ¹, Rajanit Sojitra ², Bhadresh Savaj ², Hasumati Raj ², Vineet Jain ²

Affiliations
1 Gujarat Technological University, Gujarat, IN
2 Quality Assurance Department, Shree Dhanvantary Pharmacy College, Kim, Surat, IN

Abstract

A simple, accurate and precise spectroscopic method was developed for simultaneous estimation of Irbesartan and atorvastatin in synthetic mixture using Q absorption Ratio Method. In this spectroscopic method, 234.7 nm (as an isoabsorptive point) and 226 nm wavelengths (λmax of any of the two drugs) were selected for measurement of absorptivity. Both the drugs show linearity in a concentration range of 05-30 μg/ml at their respective λmax and at the isoabsorptive point. Accuracy, precision and recovery studies were done by QC samples covering lower, medium and high concentrations of the linearity range. The relative standard deviation for accuracy, precision studies were found to be within the acceptance range (<2%). The limit of determination was 0.365μg/ml and 0.0622μg/ml for Irbesartan and atorvastatin, respectively. The limit of quantification was 1.108μg/ml and 0.188μg/ml for Irbesartan and atorvastatin, respectively. Recovery of Irbesartan and atorvastatin were found to be 100.51% and 100.16% respectively confirming the accuracy of the proposed method. The proposed method is recommended for routine analysis since they are rapid, simple, accurate and also sensitive and specific by no heating and no organic solvent extraction.

Keywords

Irbesartan, Atorvastatin, Simultaneous Estimation, Q Absorption Ratio Method, Q Value Analysis Method.

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