Informatics Publishing Limited

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

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

Abstract

The proposed study describes an isocratic reversed phase HPLC method for investigation of degradation products of Olmesartan medoxomil API under different stress conditions (acid hydrolysis degradation). Separation of Olmesartan medoxomil and its degradation products 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 followed by Base hydrolysis Structures of the degradation products were studied using a Triple Quadrapole Mass Spectrometer. A separate gradient LCMS method was developed for this purpose Depending on the degradation type, possible chemical reactions were predicted and supported by fragmentation data obtained from LC-MS/NMR. One major products were obtained in solid form using Rotavap and were then analyzed by NMR, IR and TLC to confirm their structural details.

Keywords

Olmesartan Medoxomil, Forced Degradation Studies, Degradation Products, LC, LCMS,NMR, IR and TLC.

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

Affiliations
1 Department of Quality Assurance, Shree Dhanvantry 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 simultaneous determination of Olmesartan medoxomil and Indapamide in a formulation in the presence of its degradation products. In the present study a simple, accurate and precise reverse phase liquid chromatographic method has been developed and validated for simultaneous estimation of Olmesartan medoxomil and Indapamide in tablet dosage form. 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 50-250 microg/mL (r² = 0.998) for Olmesartan medoxomil and 10-50 microg/mL (r² = 0.998) for Indapamide. The retention time of Olmesartan medoxomil and Indapamide were 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

Olmesartan Medoxomil, Indapamide, Hypertension, Stability Study.

Full Text

     

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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