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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Debi Prasad Pradhan ¹, Mukthinuthalapati Mathrusri Annapurna ¹

Affiliations
1 Department of Pharmaceutical Ananlysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM(Deemed to be University), Vishakapatnam, Andhra Pradesh-530045, IN

Abstract

Oxcarbazepine is an anticonvulsant drug used for the treatment of epilepsy. It acts by decreasing the abnormal electrical activity in the brain. A new stability indicating HPLC method was developed for the quantification of Oxcarbazepine in tablets. Waters e2695 Separations module with Waters 2489 UV detector with Hypersil BDS C18 column (250 mm x 4.6 mm, 5μ) was operated with column temperature 50°C. The detector was monitored at 215 nm and the chromatographic study was run for 20 min. Linearity was observed over 5.0-150 μg/mL with linear regression equation y = 47,910x + 6493.8 with correlation coefficient R² = 0.9999. The LOQ and LOD were found to be 4.5129 μg/mL and 1.4898 μg/mL respectively. Forced degradation studies were performed for Oxcarbazepine capsules and the method was validated as per ICH guidelines.

Keywords

Oxcarbazepine, RP-HPLC, Stability Indicating, Validation, ICH Guidelines.

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Debi Prasad Pradhan ¹, Mukthinuthalapati Mathrusri Annapurna ¹

Affiliations
1 Department of Pharmaceutical Analysis & Quality Assurance, GITAM Institute of Pharmacy, GITAM (Deemed to be University), Visakhapatnam, Andhra Pradesh-530045, IN

Abstract

Racecadotril is an anti-diarrheal drug. Waters Alliance e2695 with PDA detector (2998) Zorbax SB C18 column (150 x 4.6 mm, 3.5 μm) (Isocratic mode) was used for the quantification of Racecadotril. A mixture of water and Acetonitrile (50:50) was used as diluent and the injection volume was 20 μl. The flow rate was 1.0mL/min (Detection wave length 230 nm). Linearity was evaluated in the concentration range 1-360 μg/ml with regression equation y = 14710 x+9958.9(Correlation coefficient R² = 0.9996). The LOD and LOQ were found to be 0.2942 μg/mL and 0.9694 μg/mL respectively. Forced degradation studies were conducted for Racecadotril capsules and method validation was performed as per ICH guidelines.

Keywords

Racecadotril, LC-TQ-MS, Forced Degradation Studies, Validation, ICH Guidelines.

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