Research Journal of Pharmaceutical Dosage Form and Technology

K. Rajendra Prasad ¹, S. Kathirvel ¹

Affiliations
1 Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi road, Guntur. A.P., IN

Abstract

A simple, rapid, sensitive and precise high performance liquid chromatography (HPLC) method has been developed for the estimation of Mycophenolate mofetil in bulk and pharmaceutical dosage form. In this method RP-C18 column (250mmx4.6mm I.D and5μm particle size) with mobile phase consisting of acetonitrile and 0.02M phosphate buffer in the ratio of 50:50 v/v in isocratic mode was used. The detection wavelength is 230 nm and the flow rate is 1 ml/min. In the range of 10-60 μg/ml, the linearity of Mycophenolate mofetil shows a correlation coefficient of 0.999. The proposed method was validated by determining sensitivity, accuracy, precision and system suitability parameters. The mobile phase selected for the method is simple, fast, accurate and precise and hence can be applied for routine quality control analysis of Mycophenolate mofetil in bulk and its pharmaceutical dosage form. The method was fully validated according to ICH guidelines.

Keywords

Mycophenolate Mofetil, High Performance Liquid Chromatography, Validation.

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T. Gopi Raju ¹, M. Gayatri Ramya ², A. Rajesh ³, S. Kathirvel ³, Sanjay Kumar Gupta ⁴

Affiliations
1 Department of Pharmaceutical Chemistry, Telangana University, Nizamabad – 503322, IN
2 Department of Pharmaceutics, Acharya Nagarjuna University, Nagarjuna Nagar- 522 510, IN
3 Department of Pharmaceutics and Pharmaceutical Analysis, Hindu College of Pharmacy, Guntur -522002, IN
4 Department of Pharmaceutics, Shadan College of Pharmacy, Hyderabad, Andhra Pradesh -500008, IN

Abstract

A simple, precise, accurate and new stability-indicating reversed-phase high-performance liquid chromatographic (RPHPLC) method was developed and validated as per International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines to determine efafirenz in tablet dosage form. The drug was successfully eluted at 6.264 min by mixture of ammonium dihydrogen phosphate buffer, acetonitrile and triethylamine (30:70:1) on C18 column (150 mm × 4.6 mm, 5 μm) at the flow of 1.5 ml/min. Drug content was determined in between 99.79% and 100.33% with standard deviation of 0.217. The validated RP-HPLC method may be successfully applied for assay, dissolution studies, bio-equivalence studies, as well as routine analysis in pharmaceutical industries.

Keywords

RP-HPLC, Efavirenz, ICH.

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K. Madhu Babu ¹, S. Kathirvel ²

Affiliations
1 Department of Pharmaceutical Analysis, Hindu College of Pharmacy, Amaravathi Road, Guntur, Andhra Pradesh – 522002, IN
2 Hindu College of Pharmacy, Amaravathi Road, Guntur, Andhra Pradesh - 522002, IN

Abstract

A simple, sensitive, accurate spectrophotometric method has been developed for the estimation of Tapentadol hydrochloride in bulk and pharmaceutical formulation. The method is based on the formation of blue colored chromogen with Folin-Ciocalteu reagent in the presence of NaOH and obeys beer's law in the range of 5 - 35μg/mL exhibiting the maximum absorbance at 763nm. The limit of detection and quantification were found to be 0.76#956;g/mL and 2.33#956;g/mL respectively. The calibration curve demonstrated a linear relationship between the absorbance and concentration, with the correlation coefficient higher than 0.9999. The Regression Equation of the curve was Y=0.0248x-0.0436. The method was fully validated according to ICH guidelines.

Keywords

Tapentadol Hydrochloride, Folin-Ciocalteu (FC) Reagent, NaOH, Validation, ICH Guidelines.

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S. Kathirvel ¹, A. Suneetha ²

Affiliations
1 Hindu College of Pharmacy, Amaravathi Road, Guntur-500 002, A.P, IN
2 Hindu College of Pharmacy, Amaravathi Road, Guntur, Andhra Pradesh-522002, IN

Abstract

A simple, rapid, sensitive and precise HPLC method has been developed for the estimation of risperidone in oral solution. In this method RP-C18 Phenominex Gemini column (250 mm x 4.6 mm i.d.,5μm particle size) with mobile phase consisting of 0.5% ammonium acetate buffer, acetonitrile and methanol in the ratio of 50:20:30 v/v/v in isocratic mode was used. The detection wavelength is 260 nm and the flow rate is 1.5 mL/min. In the range of 20-100μg/mL, the linearity of risperidone shows a correlation coefficient of 0.9999. The percentage recovery ranges from 98.95-101.50%. The proposed method was validated by determining sensitivity, accuracy, precision and linearity.

Keywords

Risperidone, HPLC, Oral Solution, Validation.

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