Volume-1, Issue-1

RP-HPLC method development and validation for the simultaneous Estimation of simvastatin and ezetimibe in tablet dosage form

Mohammed. Ibrahim*, K.Rajeswar Dutt, Vadthya Rajashekar

Department of Pharmaceutical Analysis And Quality Assurance Smt. Sarojini Ramulamma College of Pharmacy, Sheshadrinagar, Mahabubnagar - 509001, Andhra Pradesh, India.

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Simvastatin and Ezetimibe in pharmaceutical tablet dosage form. Chromatographic analysis was performed on a Symmetry C8 (4.6mm x 150mm, 5μm ) column at ambient temperature with a mixture of ortho phosphoric acid buffer and Acetonitrile in the ratio 40:60 v/v (ortho phosphoric acid buffer preparation; Take 1000ml of HPLC grade water and 1 ml orthophosphoric acid and pH adjested) as mobile phase, at a flow rate of 1.0 mL min-1. UV detection was performed at 221 nm. The method was validated for accuracy, precision, specificity, linearity and sensitivity. The retention times of Simuvastatin and Ezetimibe were 2.190 and 3.515 min, respectively.

RP-HPLC Method Development and Validation for the Simultaneous Estimation of Rosuvastatin and Ezetimibe in Tablet Dosage Form

Vadthya Rajashekar*, K.Rajeswar Dutt, Santhosh Pawar V, Sudheer Kumar Sapavat

Department of Pharmaceutical Analysis and Quality Assurance Smt. Sarojini Ramulamma College of Pharmacy, Sheshadrinagar, Mahabubnagar - 509001, Andhrapradesh, India

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Rosuvastatin and Ezetimibe in pharmaceutical tablet dosage form. Chromatographic analysis was performed on a Symmetry X-terra C8 (4.6mm x 100mm, 5m)column at ambient temperature with a mixture of ortho phosphoric acid buffer and Acetonitrile in the ratio 40:60 v/v as mobile phase, at a flow rate of 1.0 mL min-1. UV detection was performed at 237 nm.. The retention times of Rosuvastatin and Ezetimibe were 2.490 and 3.173 min, respectively. The correlation coefficient of Rosuvastatin and Ezetimibe was found to be 0.999. Calibration plots were linear over the concentration ranges 10–50 μg mL-1 for Rosuvastatin and Ezetimibe, respectively. The Limit of detection was 1.626 and 0.918μg mL-1 and the quantification limit was 4.927 μg mL-1 and 2.783μg mL-1 for Rosuvastatin and Ezetimibe, respectively.

Stability indicating LC-MS method development and validation for Pravastatin

Harika. B*, Madhavi. K, Deepti. K

Department of Pharmaceutical Analysis, Smt.Sarojini Ramulamma College of Pharmacy, Mahabubnagar (509001), A.P. INDIA

A Simple, rapid, presice and accurate reversed phase stability indicating HPLC and LC-QTOF-MS/MS method was developed and validated for determination pravastatin in drug substance. The drug was subjected to acid (1N HCL), neutral and alkaline (1N NAOH) hydrolytic conditions at 800C as well as thermal studies. Photolysis was carried out in 0.1N HCL, water and 0.1 N NaOH at room temperature. Stress studies were performed on 1mg/ml solution of drug, starting with milder conditions followed by stronger conditions so as to get sufficient degradation around 5-20%.the method has shown adequate separation from pravastatin and its degradation products. The separation was achieved on a water’s C-18 (4.6x250mm,5μm) column using 0.01M Ammonium acetate pH (3.0):acetonitrile as a mobile phase in gradient elution mode by LC at flow rate of 1.0ml/min and UV detection at 238 nm. The degradation products were characterized by LC-MS/MS and its fragmentation pathways were proposed.

RP-HPLC Method Development and Validation for the Simultaneous Estimation of Metoprolol and Telmisartan in Tablet Dosage Form

K.Pranitha*, Tabassum, J.Priya, N. Rama Thilagam

M.Pharmacy , Department of Pharmaceutical Analysis, Smt.Sarojini Ramulamma College of Pharmacy, Mahabubnagar(509001) , A.P. INDIA

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Metoprolol And Telmisartan in pharmaceutical tablet dosage form. Chromatographic analysis was performed on a Symmetry X-terra C8 (4.6mm x 150mm, 5μm)column at ambient temperature with a mixture of mixed Orthophosphoric acid buffer, Acetonitrile and Methanol in the ratio 45:10:45 v/v (ortho phosphoric acid buffer preparation; Take 1000ml of HPLC grade water. Dissolve 2.72 grams of Potassium di hydrogen phosphate salt and Adjusted the pH to 3.0 with orthophosphoric acid. as mobile phase, at a flow rate of 0.7 mL min-1. UV detection was performed at 226 nm. The method was validated for accuracy, precision, linearity and sensitivity. The retention times of Metoprolol And Telmisartan were 2.473 and 3.407 min, respectively.

RP-HPLC Method Development and Validation for the Simultaneous Estimation of Atenolol and Indapamide in Pharmaceutical Tablet Dosage Form

K.Madhavi*, B.Harika & K.Deepti

M.Pharmacy, Department of Pharmaceutical Analysis & Quality Assurance, Smt. Sarojini Ramulamma College of Pharmacy, Mahabubnagar(509001), A.P. INDIA

A simple reversed-phase high-performance liquid chromatographic (RP-HPLC) method has been developed and validated for simultaneous determination of Atenolol and Indapamide in pharmaceutical tablet dosage form. Chromatographic analysis was performed on a Symmetry X-terra C8 (4.6mm x 150mm, 5μm)column at ambient temperature with a mixture of mixed Potassium di hydrogen phosphate and Acetonitrile in the ratio 40:60 v/v (Potassium di hydrogen phosphate preparation; Take 1000ml of HPLC grade water. Dissolve 2.72 grams of Potassium di hydrogen phosphate salt and Adjusted the pH to 3.0 with orthophosphoric acid. as mobile phase, at a flow rate of 0.7 mL min-1. UV detection was performed at 240 nm. The method was validated for accuracy, precision, linearity and sensitivity. The retention times of Atenolol and Indapamide were 2.1 and 3.6 min, respectively.

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