Mukthinuthalapati Mathrusri Annapurna

Determination of Cabazitaxel (An Anti-prostate cancer agent) by reverse phase liquid chromatography

Cabazitaxel is used in the treatment of hormone-refractory prostate cancer. It is a semisynthetic taxane that can be used as a precursor molecule obtained from yew tree needles. The authors have developed a stability indicating liquid chromatographic method for the determination of Cabazitaxel in pharmaceutical products. Shimadzu Model CBM-20A/20 Alite HPLC system (PDA detector) with Zorbax SB C18 column (150 mm × 4.6 mm i.d., 3.5 µm particle size) was selected for the quantification of Cabazitaxel. A mixture of tetra butyl ammonium hydrogen sulphate and methanol was used as the mobile phase with a flow rate of 1.0 mL/min (UV detection at 210 nm). The proposed analytical method was statistically validated and forced degradation studies were conducted. Cabazitaxel has shown linearity over the concentration range 0.1-200 µg/mL with regression equation y = 26145x + 22943 (r2=0.9997) and considerable degradation was observed in acidic, alkaline and oxidation conditions. The method is specific as the resolution of Cabazitaxelwas good in presence of its degradation products. This validated stability indicating liquid chromatographic method can be used for the determination of Cabazitaxel in biological studies as well as for the pharmaceutical products.

Stability Indicating RP-HPLC method for the determination of Abiraterone (An Anti-Cancer Drug)

Abiraterone is used for the treatment of prostate cancer for men. Abiraterone is available as Abiraterone acetate. Food and drug administration approves Abiraterone for treatment of men with advanced prostate cancer. A new stability indicating RP-HPLC method has been proposed for the quantification of Abiraterone. Capcell PAK C18 column (100 mm × 4.6 mm i.d., 3 µm particle size) was used for the chromatographic study of Abiraterone acetate with mobile phase mixture 0.1 % acetic acid and acetonitrile (11:89 v/v) (Flow rate: 1.2 mL/min) on Shimadzu Model CBM-20A/20 Alite HPLC system (PDA detector). Forced degradation studies were performed and the method was validated.

Method Development and Validation of a new RP-HPLC method for the simultaneous Assay of Ketorolac Tromethamine and Fluorometholone

A new RP-HPLC method has been developed and validated for the simultaneous determination of Ketorolac tromethamine and Fluorometholone pharmaceutical formulations. Shimadzu Model CBM-20A/20 Alite with C8 Phenomenex column (250 mm × 4.6 mm i.d., 5 µm particle size) was used for the proposed work with a mixture of 0.1M ammonium formate and methanol as mobile phase and flow rate 0.8 ml/min (UV detection at 241 nm). The linear regression equation was found to be y = 35207x + 29529 R² = 0.9995 for Fluorometholone and y = 68207x + 57590 R² = 0.9997 for Ketorolac tromethamine and the method was validated.

First order derivative spectrophotometric methods for the determination of Fluorometholone in ophthalmic preparations

Three simple spectrophotometric techniques have been developed for the quantification of Fluorometholone in ophthalmic preparations using sodium acetate buffer (pH 4), phosphate buffer (pH 4) and phosphate buffer (pH 7) solutions. Linearity was observed over the concentration range 2-25, 2-30 and 1-50 µg/mL in sodium acetate buffer, phosphate buffer (pH 4) and phosphate buffer (pH 7) respectively. The three methods were validated and can be applied for the assay of Fluorometholone in pharmaceutical formulations.

Simultaneous determination of Ketorolac tromethamine and Fluorometholone in Eye drops by spectrophotometry

Four simple spectrophotometric methods have been developed for the simultaneous determination of Fluorometholone and Ketorolac tromethamine in ophthalmic preparations. Simultaneous equation method, absorbance ratio method (Q – Analysis), first derivative method and multicomponent mode of analytical techniques were selected for the determination of Fluorometholone and Ketorolac tromethamine in phosphate buffer (pH 2.0) solution. Fluorometholone and Ketorolac tromethamine has followed linearity over the concentration range 0.1-20 µg/mL and 1-20 µg/mL respectively. The methods were validated and applied for the simultaneous determination of Fluorometholone and Ketorolac tromethamine in the available pharmaceutical formulations i.e. eye drops.

New Analytical Techniques for the Determination of Epalrestat in Pharmaceutical Dosage forms by Spectrophotometry

Epalrestat is an aldose reductase inhibitor. Three simple, precise and accurate Spectrophotometric methods have been developed for the determination of Epalrestat in pharmaceutical formulations. Spectrophotometric analysis was performed and linearity was observed over the concentration range 0.1-25, 0.5-20 and 0.5-20 µg/ml in phosphate buffer (pH 5.0), phosphate buffer (pH 7.0) and borate buffer (pH 9.0) respectively. All the three methods were validated and can be used for the determination of Epalrestat in pharmaceutical formulations (Tablets).

Determination of Raltegravir by derivative and difference spectrophotometric techniques in film coated tablets

Eight simple spectrophotometric techniques have been proposed for the determination of Raltegravir in pharmaceutical preparations. Three zero order (D0), three first order derivative (D!) and two difference spectrophotometric methods have been developed in for the determination of Raltegravir in borate buffer (pH 9), hydrochloric acid and sodium acetate buffer solutions. Linearity has been followed over the concentration range 1-150, 10-150 and 10-150 µg/mL in all the buffers in zero order, first order derivative and difference spectroscopy respectively. All the methods were validated and can be very successfully applied for the determination of Raltegravir in pharmaceutical formulations.

Forced Degradation Studies of Agomelatine: Development and Validation of Stability Indicating RP-HPLC Method using Internal Standard

Agomelatine is an anti-depressent drug. A new simple stability indicating reverse phase liquid chromatographic method has been established for the determination of Agomelatine in presence of an internal standard. Agomelatine is used for the treatment of prostate cancer. The proposed work has been performed on Shimadzu Model CBM-20A/20 Alite with Phenomenex C18 column (250 mm × 4.6 mm i.d., 5 µm particle size) using 0.1% formic acid and acetonitrile mixture as the mobile phase with flow rate 0.6 ml/min (UV detection at 205 nm). The method was validated as per ICH guidelines and the regression equation was found to be y = 0.2084x - 0.0475. Agomelatine was subjected to acidic, alkaline, oxidation, UV and thermal stress degradations and the method was reported to be robust and specific and can be applied for the assay of pharmaceutical formulations.

A new Stability indicating RP-HPLC method for the determination of Apremilast-An Antirheumatic drug

A novel and simple reverse phase liquid chromatographic method has been established for the determination of Apremilast in pharmaceutical dosage forms. Apremilast is used to treat psoriatic arthritis. The proposed work was performed on Shimadzu Model CBM-20A/20 Alite with Intersil ODS3 C 18 column (250 mm × 4.6 mm i.d., 5 μm particle size). A mixture of 0.1% acetic acid and acetonitrile was used as mobile phase in this method with flow rate 0.8 ml/min (UV detection at 203 nm) and the method was validated as per ICH guidelines. The linear regression equation was found to bey = 78597x - 14159 with correlation coefficient 0.9999. Forced degradation studies were performed by exposing the drug Apremilast to acidic, alkaline, oxidation and thermal stress degradations. The proposed RP-HPLC method was found to be robust and specific and this method is suitable for the assay of pharmaceutical dosage forms as well as kinetic studies.

New validated RP-HPLC method for the determination of Vilazodone hydrochloride – A serotonergic Anti-depressant

A new simple liquid chromatographic method has been established for the determination of Vilazodone hydrochloride in pharmaceutical formulations. Vilazodone hydrochloride is a strong dopamine antagonist. Vilazodone hydrochloride was approved by the FDA for use in the United States to treat major depressive disorder in January 21, 2011. A mobile phase containing0.1M Ammonium formate: Methanol (20:80, v/v) with flow rate 0.7 mL/min was used for the present chromatographic study(UV detection 241 nm). Linearity was followed over the concentration range 0.1-120 µg/mL. Forced degradation studies were performed by exposing the drug Vilazodone hydrochloride to alkaline, acidic, and oxidation stress degradations. The method was validated as per ICH guidelines (ICH Guidelines 2005).