Nehal Shah

A new simple, rapid, precise, accurate and specific stability indicating method has been developed for the simultaneous estimation of Niacin (NIA) and Lovastatin (LOVA) in tablet dosage form. A chromatographic column used for separation was (250*4.6mm i.d., 5 mm) C18 (Hyperchrome ODS-BP).The mobile phase was 0.02M Disodium hydrogen Phosphate buffer:Acetonitrile (75:25, pH-5) and UV detection of effluent at 237nm.The flow rate was 1ml/min. The retention times of Niacin and Lovastatin were 3.29 min and 4.75 min, respectively. The range of Linearity for Niacin and Lovastatin were 125-325μg/ml and 5-25 μg/ml respectively. The recoveries of Niacin and Lovastatin were found to be in the range of 99.91-100.42 % and 100.03-100.41% respectively. The optimized RP-HPLC method proved to be specific, accurate and robust for the estimation of Niacin and Lovastatin in tablet dosage form. Stability testing study includes the acid hydrolysis, base hydrolysis, oxidation, thermal degradation, and photolysis.

A Reversed-Phase High Performance liquid chromatographic (RP-HPLC) method was developed for the simultaneous determination of Ambroxol Hydrochloride and Cefpodoxime Proxetile in combined tablet dosage form. The analysis was carried out using Phenomenex Luna C – 18, pre-packed column. Mobile phase, containing Acetonitrile: 0.05 M Potassium Dihydrogen Ortho Phosphate Buffer (70:30) pH adjusted to 6.7 with Tri ethyl Amine was pumped at a flow rate of 1.0 mL/min with UV-detection at 245 nm. Retention time was 3.34 ± 0.01 min and 4.77 ± 0.01 min for Ambroxol Hydrochloride and Cefpodoxime Proxetile, respectively. The method was validated for linearity, accuracy, precision, and specificity. The method showed good linearity in the range of 30 - 60 μg/ml for Ambroxol Hydrochloride and 50 - 100 μg/ml for Cefpodoxime Proxetile. The detection limit of the proposed method was 4.56 and 12.51 μg/ml and the quantification limit was 13.82 and 37.92 μg/ml for Ambroxol Hydrochloride and Cefpodoxime Proxetile, respectively. The % recovery was within the range between 99.57% and 100.27% for Ambroxol Hydrochloride and % recovery was within the range between 99.89% and 100.86% for Cefpodoxime Proxetile. The % R.S.D for precision and accuracy of the method was found to be less than 2%. The method was validated as per the ICH guidelines. The method was successfully applied for routine analysis of Ambroxol Hydrochloride and Cefpodoxime Proxetile in combined tablet dosage form.