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Background: Vernal keratoconjunctivitis (VKC) is a recurrent, bilateral, external, ocular inflammation primarily affecting young adults living in warm dry climates. The objectives of the research was to compare the two ophthalmic solutions of olopatadine hydrochloride (0.1%) and epinastine hydrochloride (0.05%) on clinical signs of vernal keratoconjuntivitis and to determine side effects of both the drugs.Methods: The study was carried out in 40 patients who attended the out-patient department (OPD) Ophthalmology, Darbhanga Medical College and Hospital, Laheriasarai from July 2007 to December 2008. Forty patients with symptoms of VKC (ocular itching, ropy discharge, papillary hypertrophy, gelatinous thickening and horner-trantas spots were selected and included in our study.Results: Mean score of palpebral hyperemia at 0, 14, 28 and 42 days in olopatadine treated eye were 2.1, 1.4, 0.8 and 0.4 respectively having p value <0.01, and <0.01 and <0.05 respectively, while mean score at same stages in placebo eye were 2.1, 2, 1.9, and 1.5 having value >0.05. Epinastine treated group mean score of palpebral hyperemia were <0.01 and <0.01 respectively in epinastine treated eye whereas in placebo treated eye, mean score were 2.1, 2.0, 1.8 and 1.6 respectively having p value >0.05 in all stages. Statistically insignificant reduction at day 14 while very significant reduction at day 28 and 42 was observed in epinastine treated eye as compared to placebo.Conclusions: The present study had shown that both olopatadine and epinastine were effective in treating clinical signs of VKC as compared to placebo.
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A simple, specific, accurate and stability-indicating high performance liquid chromatographic method was developed and validated for the determination of Epinastine Hydrochloride in pharmaceutical dosage form. The chromatographic conditions comprised of a reverse-phase, C18 column (150×4.6 mm), 5μm with a mobile phase consisting of a mixture of aqueous phase (3.8g of sodium pantanesulphonate monohydrate and 4.0g of potassium dihydrogen orthophosphate was dissolved in 1L of water and pH of solution was adjusted to 4.5 with o-phosphoric acid) and organic phase (acetonitrile and methanol was mixed in the ratio of 4:1 v/v) in the ratio of 60:40 v/v at a flow rate of 1.0ml/min. Detection was carried out at 220nm. The retention time of Epinastine Hydrochloride was found to be 3.5 min. The calibration curve was found linear between 2-200μg/ml. The percentage recoveries of Epinastine Hydrochloride were found to be in the range of 99.05-100.50%. The method was validated for accuracy, linearity, precision, detection limit, quantitation limit and robustness. The drug was subjected to acidic hydrolysis, basic hydrolysis, neutral hydrolysis, oxidation, photochemical and thermal degradation. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different retention time. As the method could effectively separate the drug from its degradation product, it can be employed as a stability indicating one.
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A simple, specific, accurate and stability-indicating high performance liquid chromatographic method was developed and validated for the determination of Epinastine Hydrochloride in pharmaceutical dosage form. The chromatographic conditions comprised of a reverse-phase, C18 column (150×4.6 mm), 5μm with a mobile phase consisting of a mixture of aqueous phase (3.8g of sodium pantanesulphonate monohydrate and 4.0g of potassium dihydrogen orthophosphate was dissolved in 1L of water and pH of solution was adjusted to 4.5 with o-phosphoric acid) and organic phase (acetonitrile and methanol was mixed in the ratio of 4:1 v/v) in the ratio of 60:40 v/v at a flow rate of 1.0ml/min. Detection was carried out at 220nm. The retention time of Epinastine Hydrochloride was found to be 3.5 min. The calibration curve was found linear between 2-200μg/ml. The percentage recoveries of Epinastine Hydrochloride were found to be in the range of 99.05-100.50%. The method was validated for accuracy, linearity, precision, detection limit, quantitation limit and robustness. The drug was subjected to acidic hydrolysis, basic hydrolysis, neutral hydrolysis, oxidation, photochemical and thermal degradation. All the peaks of degraded product were resolved from the active pharmaceutical ingredient with significantly different retention time. As the method could effectively separate the drug from its degradation product, it can be employed as a stability indicating one.
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To determine the pharmacokinetics and bioequivalence of epinastine (EPN) hydrochloride, a promising histamine H1 receptor antagonist, in healthy Chinese volunteers under fasting conditions. METHODS: EPN hydrochloride test and reference tablets were administered as a single dose on two treatment days separated by a 1-week washout period. After dosing, serial blood samples were collected for a period of 36 h, and plasma EPN hydrochloride concentrations were determined by a validated reversed-phase HPLC method and pharmacokinetic parameters were calculated with DAS software. RESULTS: Plasma concentration-time profiles were adequately described by a two-compartment open model. The compound was rapidly absorbed and cleared slowly from plasma with a half-life of approximately 10 h. The main pharmacokinetic parameters of EPN hydrochloride test and reference tablets were as follow: tmax were (2.2±0.5) and (2.0±0.4)h, Cmax were (66±16)and (68±13)μg/L, t1/2 were(10.1±1.3) and (10.4±2.4)h, AUC0-36 were (592±88) and (601±94)μg·h·L-1, respectively. The relative bioavailability of test tablets was (99±13)%. CONCLUSION: The results indicate that the two formulations of EPN hydrochloride tablets are bioequivalent in the rate and extent of absorption.
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0.05).The relative bioavailability of domestic EPST tablets was(96.70?14.47)%.CONCLUSION: The result of the statistical analysis showed that the two formulations of EPST were bioequivalent.