Asian Journal of Pharmacy and Technology

Virani Paras ¹, Virani Kinjal ²

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

Abstract

Analytical method is primary requirement of the pharmaceutical industry. In pharmaceutical industry various analytical methods is used like chromatography, spectroscopy method, electrochemical method, ion incorporating method, etc. Irbesartan is Irbesartan is classified as an angiotensin II receptor type 1 antagonist. Angiotensin II receptor type 1 antagonists are widely used in treatment of diseases like hypertension, heart failure, myocardial infarction and diabetic nephropathy. Atorvastatin is the most efficacious of the currently available HMG-CoA Reductase inhibitors used in anti lipidemic and also used in atherosclerosis, stroke and cardiac risk. In recently approved new fixed dose combination of Irbesartan and atorvastatin in market of Korea so it require analytical method development which help in industry for new drug delivery system development. This review highlights the role, need and application of various analytical techniques for Irbesartan and atorvastatin combination and their corresponding analytical methods in the pharmaceutical industry.

Keywords

Analytical Method, Irbesartan, Atorvastatin, Pharmaceutical Industry, Fixed Dose Combination.

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Virani Paras ¹, Sojitra Rajanit ¹, Savaj Bhadresh ¹, Raj Hashumati ¹, Jain Vineet ¹, Patel Kalpesh ¹, Sutariya Vishnu ¹

Affiliations
1 Quality Assurance Department, Shree Dhanvantary Pharmacy College, Kim, Surat, IN

Abstract

A simple, accurate, rapid and precise reverse phase high performance liquid chromatographic method was developed for simultaneous estimation of Irbesartan and Atorvastatin in synthetic mixture. Inertsil C18, 150 mm x 4.6 mm, 5 μm particle size in gradient mode with mobile phase Acetonitrile: 0.1% Formic acid (40: 60 v/v) and pH adjusted to 3.5 ± 0.1 with orthophosphoric acid was used. The flow rate was 1.0 ml/min and absorbance of individual component was measured at 262 nm. The retention times of Irbesartan and Atorvastatin were found to be 3.993 and 7.733 min, respectively. Linearity for Irbesartan and Atorvastatin was in the range of 400 - 800 and 50- 100μg/ml with correlation coefficient values 0.9995and 0.9994, the percentage recovery obtained was 99.88and 99.70 %, respectively.

Keywords

Irbesartan, Atorvastatin, RP-HPLC, Method Validation.

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Sojitra Rajanit ¹, Virani Paras ¹, Hashumati Raj ¹

Affiliations
1 Department of Quality Assurance, Shree Dhanvantry Pharmacy College, Kim, Surat, IN

Abstract

A new simple, economical, precise and accurate method are described for the simultaneous determination of Nifedipine (NIF) and Metoprolol Succinate (MET) in combined tablet dosage form. The proposed method was applied for the determination of Nifedipine and Metoprolol Succinate in synthetic mixture, for determination of sampling wavelength, 10μg/ml of each of NIF and MET were scanned in 200-400 nm range and sampling wavelengths were 313nm for NIF and 275.40nm for MET are selected for development and validation of absorption correction method. For this method linearity observed in the range of 5-25μg/ml for NIF and 25-125μg/ml for MET, and in their pharmaceutical formulation with mean percentage recoveries 100.68 and 100.33, respectively. The method was validated according to ICH guidelines and can be applied for routine quality control testing.

Keywords

Spectroscopic Method, Absorption Correctedmethod, Nifedipine And Metoprolol Succinate.

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