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P. Rudra Mohan Reddy ¹, J. Sreeramulu ¹, Petla Y. Naidu ², A. Rajasekhara Reddy ³

Affiliations
1 Department of Chemistry, S.K. University, Anantapur 515003, IN
2 Hospira Healthcare India Pvt. Ltd., SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kancheepuram District, Tamilnadu 602105, IN
3 Orchid Chemicals and Pharmaceuticals Ltd, SIPCOT Industrial Park, Irungattukottai, Sriperumbudur, Kancheepuram District, Tamilnadu 602105, IN

Abstract

A reversed-phase high-performance liquid chromatographic method for separation and quantification of impurities of Cefprozil powder for oral suspension dosage form has been developed and validated. Chromatography was performed on a 100 x 4.6 mm, 1.8-μm particle, C18 column with mobile phase-A, 0.23 % Ammonium dihydrogen orthophosphate in water and mobile phase-B, 80 : 20 (v/v) Methanol - mobile phase-A by gradient elution. The system was operated at 0.6 mL min^-1 mobile phase flow rate and the column thermostat was maintained at 25°C. UV detection was performed at 290 nm. Forced degradation studies were conducted on Drug product using ICH stress study guidelines to demonstrate the specificity and stability-indicating nature of the method. The method was validated for precision, accuracy, linearity, specificity and sensitivity in accordance with ICH guidelines. LOD and LOQ for individual impurities were below 0.014 and 0.037 % (w/w) respectively. Validation revealed the method is specific, precise, accurate, linear, robust and reproducible.

Keywords

RP-HPLC, Cefprozil, Validation, Forced Degradation.

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Paluru Rudra Mohan Reddy ¹, J. Sreeramulu ¹, Petla Y. Naidu ², A. Rajasekhara Reddy ³

Affiliations
1 Department of Chemistry, S.K. University, Anantapur-515003, IN
2 Hospira Healthcare India Pvt. Ltd., SIPCOT Industrial Park, Irungattukottai, Sriperumbudur-602105, Kancheepuram District, Tamilnadu, IN
3 Orchid Chemicals and Pharmaceuticals Ltd, SIPCOT Industrial Park, Irungattukottai, Sriperumbudur-602105, Kancheepuram District, Tamilnadu, IN

Abstract

A fast, stability-indicating reversed phase liquid chromatographic method has been developed and subsequently validated for the estimation of impurities of Cephalexin. The developed method utilizes the chemistry of sub 2-μm C-18 column and mobile phase consisting of Potassium dihydrogen phosphate buffer-acetonitrile with gradient elution, at a flow rate of 1.0 mL per minute. The detection was carried out at 254 nm. As there are no simple Fast LC methods reported for the estimation of Impurities/degradants of Cephalexin in Pharmaceutical formulations, the current method was developed and validated. The method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification, ruggedness and robustness. This method has been successfully applied to pharmaceutical formulation and no interference from the excipients used the powder for suspension was found. As the proposed method could effectively separate the drug from its degradants/impurities, it can be employed as stability-indicating method for the determination of instability of the drug in bulk and pharmaceutical formulations.

Keywords

Liquid Chromatography, Drug Product, Degradants, Stability Indicating.

Full Text

     

Paluru Rudra Mohan Reddy ¹, J. Sreeramulu ¹, Petla Y. Naidu ², A. Rajasekhara Reddy ²

Affiliations
1 Department of Chemistry, S.K. University, Anantapur-515003, IN
2 Orchid Chemicals and Pharmaceuticals Ltd, SIPCOT Industrial Park, Irungattukottai, Sriperumbudur-602105, Kancheepuram District, Tamilnadu, IN

Abstract

A fast, stability-indicating reversed phase liquid chromatographic method has been developed and subsequently validated for the estimation of impurities of Pantoprazole. The developed method utilizes sub 2-μm C-18 column and mobile phase consisting of ammonium acetate buffer-acetonitrile with gradient elution, at a flow rate of 0.8 mL per minute. The detection was carried out at 290 nm. The method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification, ruggedness and robustness. This method has been successfully applied to pharmaceutical formulation and no interference from the tablet excipients was found. As the proposed method could effectively separate the drug from its degradants / impurities, ie, pantoprazole related compound A (PA), pantoprazole related compound B (PB), pantoprazole related compound C (PC) and pantoprazole related compound DandF (PDF), it can be employed as stability-indicating method for the determination of instability of the drug in bulk and pharmaceutical formulations.

Keywords

Liquid Chromatography, Pantoprazole, Stability Indicating, Drug Product.

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