Asian Journal of Pharmacy and Technology

Rucha A. Patel ¹, Meghna P. Patel ¹, Hasumati Raj ¹, Nehal Shah ²

Affiliations
1 Department of Quality Assurance, Shree Dhanvantary Pharmacy College, Kim, Surat, Gujarat, IN
2 Dharmaj Degree of Pharmacy, Dharmaj, Anand, Gujarat, IN

Abstract

An approach of forced degradation study was successfully applied for the development of a stability-indicating high performance liquid chromatographic method for Indapamide in the presence of its degradation products. In the present study a simple, accurate and precise reverse phase liquid chromatographic method has been developed of Olmesartan Indapamide in bulk. Developed Method was achieved on symmetry C18 (150 mm × 4.6 mm, 5 μ) column using a Acetonitrile: 0.02 M Na2HPO4(45:55 v/v) mobile phase and pH 7 adjusted with ortho phosphoric acid. Isocratic elution mode at a flow rate of 1.0 ml/min at Room temperature with a load of 20μl Injection volume. The detection was carried out at 240 nm. The linearity of the proposed method was investigated in the range of 10-50 microg/mL (r2 = 0.998) for Indapamide. The retention time of Indapamide was found to be around 4.79 min and 7.59 min respectively. The drug substances were subjected to stress conditions of acid hydrolysis, base hydrolysis, Oxidative, photolytic and thermal. The developed RP-HPLC method was validated with respect to linearity, accuracy, precision, robustness, LOD and LOQ.

Keywords

Indapamide, Hypertension, Stability Study.

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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

The present manuscript describe simple, sensitive, rapid, accurate, precise and economical first derivative spectrophotometric method for the simultaneous determination of Irbesartan (IRB) and Atorvastatin (ATR) in synthetic mixture. The derivative spectrophotometric method was based on the determination of both the drugs at their respective zero crossing point (ZCP). The first order derivative spectra was obtained in methanol and the determinations were made at 225.20 nm (ZCP of Atorvastatin) for Irbesartan and 308.15 nm (ZCP of Irbesartan) for Atorvastatin. The linearity was obtained in the concentration range of succinate 5-30 μg/ml for Irbesartan and 5- 30 μg/ml for Atorvastatin Succinate. The mean recovery was 99.25 and 99.65% for Irbesartan and Atorvastatin succinate, respectively. The method was found to be simple, sensitive, accurate and precise and was applicable for the simultaneous determination of Irbesartan and Atorvastatin in synthetic mixture. The results of analysis have been validated statistically and by recovery studies. 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,First Order Derivative, Spectroscopy.

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