P. Ramalingam

An accurate and precise stability-indicating RP-HPLC method has been developed and validated for the analysis of Erlotinib HCl in tablet dosage forms. The method was developed on a Qualisil Gold C18 (250×4.6mmi.d, 5μm particle size) analytical column using methanol: water in the ratio of 58:42(v/v) as the mobile phase. The instrumental settings were flow rate 1mL/min, column temperature 23oC and the detection wavelength of 246nm using a Photo Diode Array (PDA) detector. The method is linear over a range of 5-50μg/ml. The LOD and LOQ values were found to be 0.81μg/mL and 2.466μg/mL respectively. Erlotinib was exposed to acidic, alkaline, oxidative, photolytic, thermal stress conditions and these stressed samples were analyzed by the proposed method. The drug product was completely separated from the degradants which indicates that the method is specific. Key-words: ErlotinibHCl, RP-HPLC, Stress degradation studies.

  An accurate, precise and reproducible Reverse Phase High Performance Liquid Chromatographic (RP-HPLC) method was developed and validated for the estimation of Metformin Hydrochloride, Glimepiride and Atorvastatin in Pharmaceutical dosage forms. In this method Qualisil gold C18 column (250mmx4.6mm I.D., 5µm particle size) with mobile phase containing 0.1% TFA in Water (pH adjusted to 2.92 with ammonia) and Methanol in the ratio of 28: 72v/v was used. The flow rate was 1ml/min. and the detection wavelength was 235nm1-2. The linearity was observed in the range of 50 - 225µg/ml, 0.2 - 0.9µg/ml and 1 – 4.5 µg/ml for Metformin Hydrochloride, Glimepiride and Atorvastatin with correlation coefficient of 0.9992, 0.9992, and 0.9997 respectively. Retention times were 3.1min, 7.8min, and 10.1min for Metformin Hydrochloride, Atorvastatin and Glimepiride respectively. The proposed method was validated for Linearity, accuracy, precision and Robustness. The proposed method was validated as per ICH guidelines and can be applied for routine quality control analysis of pharmaceutical dosage forms used for Multidrug therapy containing Metformin Hydrochloride, Glimepiride and Atorvastatin. Key words: RP-HPLC, OPA, Multidrug therapy, ICH, Validation.

An accurate, precise and economic reversed phase high performance liquid chromatographic (RP-HPLC) method was developed and validated for the estimation of lamivudine, zidovudine and nevirapine in pharmaceutical dosage forms. In this method Qualisil BDS C8 column (250mmx4.6mm i.d., 5µm particle size) with mobile phase containing water and acetonitrile in the ratio of 70: 30 v/v with pH adjusted to 5 with ortho phosphoric acid (OPA). The flow rate was 1mL/min and the detection wavelength was 250nm. The linearity was observed in the range of 1-15µg/mL for lamivudine, 3-24 µg/mL for zidovudine and 2.5-20 µg/mL for nevirapine. Retention times were 3.1min, 4.4min, and 7.0min for lamivudine, zidovudine and nevirapine respectively. The proposed method was validated as per ICH guidelines for linearity, accuracy, precision and robustness and can be applied for routine quality control analysis of pharmaceutical dosage forms used for multidrug therapy containing lamivudine, zidovudine and nevirapine.