A stability-indicating high performance liquid chromatographic (HPLC) assay for the simultaneous determination of atorvastatin and amlodipine in commercial tablets
- Mohammadi, Ali, Rezanour, N, Ansari Dogaheh, M, Ghorbani Bidkorbeh, F, Hashem, M, Walker, Roderick B
- Authors: Mohammadi, Ali , Rezanour, N , Ansari Dogaheh, M , Ghorbani Bidkorbeh, F , Hashem, M , Walker, Roderick B
- Date: 2007
- Language: English
- Type: Article
- Identifier: vital:6403 , http://hdl.handle.net/10962/d1006340
- Description: A simple, rapid, precise and accurate isocratic reversed-phase stability-indicating HPLC method was developed and validated for the simultaneous determination of atorvastatin (AT) and amlodipine (AM) in commercial tablets. The method has shown adequate separation for AM, AT from their associated main impurities and their degradation products. Separation was achieved on a Perfectsil® Target ODS-3, 5 μm, 250 mm × 4.6 mm i.d. column using a mobile phase consisting of acetonitrile–0.025 M NaH2PO4 buffer (pH 4.5) (55:45, v/v) at a flow rate of 1 ml/min and UV detection at 237 nm. The drugs were subjected to oxidation, hydrolysis, photolysis and heat to apply stress conditions. The linearity of the proposed method was investigated in the range of 2–30 μg/ml (r = 0.9994) for AT and 1–20 μg/ml (r = 0.9993) for AM. The limits of detection were 0.65 μg/ml and 0.35 μg/ml for AT and AM, respectively. The limits of quantitation were 2 μg/ml and 1 μg/ml for AT and AM, respectively. Degradation products produced as a result of stress studies did not interfere with the detection of AT and AM and the assay can thus be considered stability-indicating.
- Full Text:
- Date Issued: 2007
- Authors: Mohammadi, Ali , Rezanour, N , Ansari Dogaheh, M , Ghorbani Bidkorbeh, F , Hashem, M , Walker, Roderick B
- Date: 2007
- Language: English
- Type: Article
- Identifier: vital:6403 , http://hdl.handle.net/10962/d1006340
- Description: A simple, rapid, precise and accurate isocratic reversed-phase stability-indicating HPLC method was developed and validated for the simultaneous determination of atorvastatin (AT) and amlodipine (AM) in commercial tablets. The method has shown adequate separation for AM, AT from their associated main impurities and their degradation products. Separation was achieved on a Perfectsil® Target ODS-3, 5 μm, 250 mm × 4.6 mm i.d. column using a mobile phase consisting of acetonitrile–0.025 M NaH2PO4 buffer (pH 4.5) (55:45, v/v) at a flow rate of 1 ml/min and UV detection at 237 nm. The drugs were subjected to oxidation, hydrolysis, photolysis and heat to apply stress conditions. The linearity of the proposed method was investigated in the range of 2–30 μg/ml (r = 0.9994) for AT and 1–20 μg/ml (r = 0.9993) for AM. The limits of detection were 0.65 μg/ml and 0.35 μg/ml for AT and AM, respectively. The limits of quantitation were 2 μg/ml and 1 μg/ml for AT and AM, respectively. Degradation products produced as a result of stress studies did not interfere with the detection of AT and AM and the assay can thus be considered stability-indicating.
- Full Text:
- Date Issued: 2007
The comparison of in vitro release methods for the evaluation of oxytocin release from Pluronic® F127 parenteral formulations
- Chaibva, Faith A, Walker, Roderick B
- Authors: Chaibva, Faith A , Walker, Roderick B
- Date: 2007
- Language: English
- Type: Article
- Identifier: vital:6351 , http://hdl.handle.net/10962/d1006033
- Description: The objective of these studies was to develop a discriminatory in vitro release test for assessing formulation factors that may affect oxytocin (OT) release during formulation development studies of a Pluronic® F127 OT in situ gel-forming parenteral dosage form. An appropriate release assessment method should be able to discriminate between the performance of different formulation compositions (1, 2), and this was the primary criterion used for selection of an appropriate test procedure during the test method development process. ANOVA and the difference (f1) and similarity (f2)factors were used to evaluate the discriminatory behavior of different test methods that were investigated in these studies. The in vitro release tests that were investigated included the use of USP Apparatus 1, 2, and 3; a dialysis bag in USP Apparatus 2; and a membrane-less diffusion method. It was concluded that the use of USP Apparatus 3 was best able to discriminate between OT release for the different formulations tested. USP Apparatus 3 was thus considered the most suitable in vitro release test apparatus for studying formulation factors affecting OT release during the development of a parenteral dosage form prepared using Pluronic® F127.
- Full Text:
- Date Issued: 2007
- Authors: Chaibva, Faith A , Walker, Roderick B
- Date: 2007
- Language: English
- Type: Article
- Identifier: vital:6351 , http://hdl.handle.net/10962/d1006033
- Description: The objective of these studies was to develop a discriminatory in vitro release test for assessing formulation factors that may affect oxytocin (OT) release during formulation development studies of a Pluronic® F127 OT in situ gel-forming parenteral dosage form. An appropriate release assessment method should be able to discriminate between the performance of different formulation compositions (1, 2), and this was the primary criterion used for selection of an appropriate test procedure during the test method development process. ANOVA and the difference (f1) and similarity (f2)factors were used to evaluate the discriminatory behavior of different test methods that were investigated in these studies. The in vitro release tests that were investigated included the use of USP Apparatus 1, 2, and 3; a dialysis bag in USP Apparatus 2; and a membrane-less diffusion method. It was concluded that the use of USP Apparatus 3 was best able to discriminate between OT release for the different formulations tested. USP Apparatus 3 was thus considered the most suitable in vitro release test apparatus for studying formulation factors affecting OT release during the development of a parenteral dosage form prepared using Pluronic® F127.
- Full Text:
- Date Issued: 2007
The effects of buffer molarity, agitation rate and mesh size on verapamil release from modified release mini-tablets using USP Apparatus 3
- Khamanga, Sandile M, Walker, Roderick B
- Authors: Khamanga, Sandile M , Walker, Roderick B
- Date: 2007
- Language: English
- Type: text , Article
- Identifier: vital:6386 , http://hdl.handle.net/10962/d1006307
- Description: The effects of agitation rate, buffer molarity,and mesh size on the dissolution rate of verapamil hydrochloride from sustained release matrix tablets were studied using USP Apparatus 3. Eudragit® and Carbopol® were used as rate-retarding polymers in tablets prepared by wet granulation.The study was conducted to determine whether the drugs exhibit similar release characteristics when tested under the same dissolution conditions. It was found that the dissolution rate of verapamil hydrochloride was affected by the variables assessed in these studies.
- Full Text:
- Date Issued: 2007
- Authors: Khamanga, Sandile M , Walker, Roderick B
- Date: 2007
- Language: English
- Type: text , Article
- Identifier: vital:6386 , http://hdl.handle.net/10962/d1006307
- Description: The effects of agitation rate, buffer molarity,and mesh size on the dissolution rate of verapamil hydrochloride from sustained release matrix tablets were studied using USP Apparatus 3. Eudragit® and Carbopol® were used as rate-retarding polymers in tablets prepared by wet granulation.The study was conducted to determine whether the drugs exhibit similar release characteristics when tested under the same dissolution conditions. It was found that the dissolution rate of verapamil hydrochloride was affected by the variables assessed in these studies.
- Full Text:
- Date Issued: 2007
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