Research Journal of Pharmaceutical Dosage Form and Technology

N. Sunitha ¹, Y. Sujitha ¹, B. Thangabalan ¹, S. Manohar Babu ¹

Affiliations
1 Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), IN

Abstract

A simple, fast, precise, selective and accurate RP-HPLC method was developed and validated for the simultaneous determination of Ketorolac tromethamine and olopatadine HCl from bulk and formulations. Chromatographic separation was achieved isocratically on a Inertsil ODS C18 column (250×4.6 mm, 5 μ particle size) using a mobile phase 0.1 M Sodium di hydrogen orthophosphate: Acetonitrile in the ratio of 55:45. The flow rate was 1 ml/min and effluent was detected at 235nm. The retention time of Ketorolac and olopatadine were 2.507 min and 4.933 min. respectively. Linearity was observed in the concentration range of 4-24μg/ml and 12-72μg/ml for Ketorolac and olopatadine respectively with correlation coefficient of 0.999 for both the drugs. Percent recoveries obtained for ketorolac and olopatadine were 100.03% and 100.04%, respectively. The method was validated according to the ICH guidelines with respect to specificity, linearity, accuracy, precision and robustness. The method developed can be used for the routine analysis of Ketorolac and olopatadine from their combined dosage form.

Keywords

RP-HPLC Method, UV-VIS Detection, Keterolac and Olopatadine Ophthalmic Formulation.

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B. Thangabalan ¹, Ch. Sandhya ¹, N. Sunitha ¹, S. Manohar Babu ¹

Affiliations
1 Department of Pharmaceutical Analysis, SIMS College of Pharmacy, Mangaldas Nagar, Guntur-522 002 (A.P.), IN

Abstract

A simple, fast and precise stability indicating RP - HPLC method was developed for the quantification of Memantine HCl in pure and pharmaceutical dosage form. The quantification was carried out using Intersil ODS C18 4.6 X 150mm, 5μm enhanced polar selectivity column and mobile phase comprised of 0.2M sodium dihydrogen phosphate&0.1M disodium hydrogen phosphate buffer of pH adjusted to 3 with orthophosphoric acid and Acetonitrile in proportion of ratio 50:50 and degassed under ultrasonication. The flow rate was 1ml/min and the effluent was monitored at 272nm. The retention time of Memantine HCl was found to be 3.337 min. The method was validated in terms of linearity, precision, accuracy, specificity, robustness, limit of detection and limit of quantitation in accordance with ICH guidelines. Linearity of Memantine was in the range of 20 - 120 μg/mL. The percentage recoveries of Memantine were 99.66% to 102.5% from the tablet formulation. The stability - indicating capability was established by forced degradation experiments. The proposed method is suitable for determination of Memantine HCl in pharmaceutical dosage form.

Keywords

Chromatography, Memantine HCI, Method Validation, Forced Degradation Study.

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