Informatics Publishing Limited

A. M. Krupanidhi , H. M. Vagdevi , C. S. Shreedhara , V. P. Vaidya , K. S. Muralikrishna

Abstract

Objective: To study the neuropharmacological activities of the ethanolic extract of Dodonaea viscosa seeds. Materials and methods: Neuropharmacological activities includes behavioural assessment, pentobarbitone-induced sleeping time, motor coordination activity and locomotor activity of the Dodonaea viscosa seeds ethanolic extract was evaluated at the dose of 30 mg/kg and 20 mg/kg (p.o.) respectively. Results: Ethanolic extract of Dodonaea viscosa seeds potentiated phenobarbitone - induced sleeping time, reduced locomotion and the same extract did not induce motor in coordination at dose levels of 30 mg/kg and 20 mg/kg (p.o.). Conclusion: The results of present study have revealed that the ethanolic extract of Dodonaea vsiscosa showed excellent neuropharmacological activities and there is a scope for further envisage.

Keywords

Dodonaea viscosa Seeds, Ethanolic Extract, Hypnosis, Rotarod, Actophotometer

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A. Kasad Pinaz ¹, K. S. Muralikrishna ¹

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

Abstract

A simple, precise and accurate HPLC method has been developed and validated for assay of Rivaroxaban. An isocratic separation was achieved using a phenomenex C18(250×4.6 mm, 5μm),100°A particle size columns with a flow rate of 1 ml/min and using a PDA detector to monitor the elute at 250 nm. The mobile phase consisted of Methanol: Acetronitrile (50:50, v/v). The method was validated for specificity, linearity, precision, accuracy and robustness. The method was linear over the concentration range of 20-100 μg/ml (r²= 0.99995). Intraday system and method precision were determined and accuracy was 99.89 %. The method was found to be robust and suitable for assay of Rivaroxaban in a tablet formulation. Degradation products resulting from the stress studies did not interfere with the detection of Rivaroxaban and the assay is thus stability-indicating.

Keywords

Rivaroxaban, Oral Anticoagulant, 250 nm, Stability Indicating Method, Acid Degradation

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Pinaz A. Kasad ¹, K. S. Muralikrishna ¹

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

Abstract

Rivaroxaban, anti-coagulant is a novel drug for the prevention of venous thromboembolism (VTE) in patients who have undergone elective total hip replacement or total knee replacement surgery and no dissolution study for its estimation has been reported yet. The aim of this work was to develop and validate a dissolution profile for Rivaroxaban in a tablet dosage form using RP-HPLC method. The conditions established for dissolution were: 900 mL of acetate buffer pH=4.5 + 0.2 % sodium lauryl sulphate (SLS) as dissolution medium, using a paddle type dissolution apparatus at a stirring rate of 75 rpm which was able to give % drug release of 98.86% . The drug release was evaluated by RP-HPLC method at 250 nm and a good linearity was observed in the concentration range of 20-60 μg/mL with correlation coefficient of 0.9989. The percentage recovery of Rivaroxaban was found to be 99.63 and % CV (0.22 %; n=6) indicated a good precision of the analytical method.. Robustness of the method was performed by using different rotation speeds and Temperatures. The validation parameters included linearity, accuracy, precision and robustness. Analytical method validation was found to be within the acceptance criteria of the guidelines of ICH Q2 R1, FDA and FIP. The proposed method can be applied for routine quality control analysis of Rivaroxaban

Keywords

Rivaroxaban, Validation, Dissolution Apparatus,RP-HPLC Method, 250 nm

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Pinaz A. Kasad ¹, K. S. Muralikrishna ¹

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

Abstract

A simple, precise and accurate HPLC method has been developed and validated for assay of Rivaroxaban. An isocratic separation was achieved using a phenomenex C18 (250×4.6 mm, 5μm), 100°A particle size columns with a flow rate of 1 ml/min and using a PDA detector to monitor the elute at 250 nm. The mobile phase consisted of Methanol: Acetronitrile (50:50, v/v). The method was validated for specificity, linearity, precision, accuracy and robustness. The method was linear over the concentration range of 20-100 μg/ml (r²= 0.99995).The Drug was subjected to base degradation. The method was found to be robust and suitable for routine analysis of Rivaroxaban. Degradation products resulting from the stress studies did not interfere with the detection of Rivaroxaban and the method is thus stability-indicating.

Keywords

Rivaroxaban, Oral Anticoagulant, 250 nm, Stability Indicating Method, Base Degradation

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Anitha Karun ¹, M. K. Rajesh ¹, K. S. Muralikrishna ¹

Affiliations
1 Division of Crop Improvement, ICAR-Central Plantation Crops Research Institute, Kasaragod 671 124, IN

Abstract

No Abstract.

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A. Kasad Pinaz ¹, K. S. Muralikrishna ¹

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

Abstract

The present research work discusses the development of an Area under the Curve spectrophotometric method for Rivaroxaban. Simple, sensitive, reproducible, accurate, rapid, simple and cost efficient spectrophotometric method has been developed for the estimation of Rivaroxaban in bulk and dosage form. The optimum conditions for the analysis of the drug were established. The study was conducted in Methanol between the wavelengths of 241nm- 260 nm. The method validations was accomplished through evaluation of analytical parameters of linearity, range, accuracy and precision, limit of detection and limit of quantification and robustness as per ICH guidelines. The developed method was linear (r2= 0.999) in the concentration range of 2-12 μg/ml, precise (Mean %RSD inter day is 0.537 and Mean %RSD intraday is 0.297), accurate (% recovery= 99.31%) and sensitive (LOD and LOQ of 0.059 and 0.179 μg/ml respectively). The proposed method is observed to be suitable for the analysis of Rivaroxaban in bulk and Dosage form for quality control purposes.

Keywords

Rivaroxaban, Oral Anticoagulant, AUC Method, Validation.

Full Text

     

A. Kasad Pinaz ¹, K. S. Muralikrishna ¹

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

Abstract

A simple, precise and accurate HPLC method has been developed and validated for assay of Rivaroxaban. An isocratic separation was achieved using a phenomenex C18 (250×4.6 mm, 5μm), 100°A particle size columns with a flow rate of 1 ml/min and using a PDA detector to monitor the elute at 250 nm. The mobile phase consisted of Methanol: Acetronitrile (50:50, v/v). The method was validated for specificity, linearity, precision, accuracy and robustness. The method was linear over the concentration range of 20-100 μg/ml (r²=0.99995). The Drug was subjected to base degradation. The method was found to be robust and suitable for routine analysis of Rivaroxaban. Degradation products resulting from the stress studies did not interfere with the detection of Rivaroxaban and the method is thus stability-indicating.

Keywords

Rivaroxaban, Oral Anticoagulant, 250 nm, Stability Indicating Method, Base Degradation.

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