Research Journal of Pharmacy and Technology

Mukthinuthalapati Mathrusri Annapurna ¹, Debi Prasad Pradhan ¹, Malineni Sushmitha ¹

Affiliations
1 Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, IN

Abstract

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 C₁₈ 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.

Keywords

Apremilast, RP-HPLC, Validation, Stability-Indicating.

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Mukthinuthalapati Mathrusri Annapurna ¹, Vellanki S. V. Sevyatha ¹, Malineni Sushmitha ¹

Affiliations
1 Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam-530045, IN

Abstract

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.

Keywords

Fluorometholone, Ketorolac Tromethamine, Spectrophotometry, Simultaneous Equation Method, Simultaneous Derivative, Multicomponent Analysis, Q-Analysis, Validation.

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Mukthinuthalapati Mathrusri Annapurna ¹, Malineni Sushmitha ¹, Kunala Anusha ¹

Affiliations
1 Department of Pharmaceutical Analysis and Quality Assurance, GITAM Institute of Pharmacy, GITAM University, Visakhapatnam, IN

Abstract

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).

Keywords

Epalrestat, Phosphate Buffer and Borate Buffer, Spectrophotometry, Validation.

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