RP-HPLC method development and validation for quantification of daclatasvir dihydrochloride and its application to pharmaceutical dosage form.

Daclatasvir dihydrochloride is an antiviral drug used in the treatment of Hepatitis C and for its estimation in drug product, no Pharmacopeial method is available. Therefore, a simple, rapid, precise and accurate isocratic RP-HPLC method was developed and validated for quantification of daclatasvir dihydrochloride in pharmaceutical dosage form. The quantification was carried out using Hypersil ODS - C18 Column (250mm, 4.6mm, 5µm), Shimadzu LC-2030 Prominence-I Series. The mobile phase composed of phosphate buffer (pH 3.5, adjusted with ortho phosphoric acid) and acetonitrile (60:40 v/v). The flow rate was 1.0ml/min with UV detection at 308 nm. The validation of developed method was conducted for specificity, linearity, accuracy, precision, LOD and LOQ. A linearity was established in the concentration range of 0.5-150% with coefficient of correlation 0.9993. The limit of detection (LOD) was 0.005µg/ml and the limit of quantification (LOQ) was 0.01µg/ml. The method was successfully applied to the assay and in-vitro dissolution studies of daclatasvir dihydrochloride in tablet dosage form. It can be concluded that this method can be very helpful in the quality control estimation of daclatasvir dihydrochloride in different pharmaceutical products intended for hepatitis C infections.

Comparative pharmacokinetic evaluation of extended release itopride HCl pellets with once daily tablet formulation in healthy human subjects: a two treatment, four period crossover study in fasted and fed condition.

OBJECTIVE: In this study, pharmacokinetics (PKs) and bioavailability of newly developed extended release (ER) Itopride HCl 150 mg encapsulated ER pellets (test) and 150 mg Ganaton ER once-daily (OD) tablets (reference) were compared and evaluated under fasted and fed conditions. METHODS: Twelve healthy human subjects were enrolled in a single dose, randomized; two treatments, two sequences, four period crossover study. A modified and validated liquid chromatographic method was used for the estimation of Itopride HCl in plasma samples. The data were analyzed through non-compartmental model using PK software Phoenix Winnonlin version 7. The outcome was measured on logarithmically transformed data, where p > 0.05 was considered as non-significant with 90% CI limit of 0.8-1.25. RESULTS: The Cmax, AUC0-t, and AUC0-∞ values of Itopride HCl 150 mg ER pellets versus that of OD 150 mg tablets, in fed and fasted states, were within the limits specified by FDA to establish bioequivalence. The relative bioavailability of Itopride HCl 150 mg ER pellets were 1.019 (fed) and 1.081(fasted). The 90% CIs of AUC values for Itopride HCl 150 mg ER pellets and OD 150 mg tablets in fed versus fast were significantly greater and were not within 80-125% limit. CONCLUSION: The test and reference formulations had similar pharmacokinetic parameters in each condition studied. However, an increase in the amount of drug was observed in the fed state.

Drug development of herbomineral capsule (ALG-06) used for hypopigmentation specially in vitiligo.

Many herbomineral preparations in traditional medicines are being used from time immemorial like Kushta Abrak Safaid, Busoor-e-Labinyah etc. as therapeutics remedies in common ailments such type of preparations are known to have additive and pronounced effects to cure any obstinate disease condition. The main objective of this research study is the formulation of herbomineral capsule (ALG-06) to treat such type of condition like hypopigmentation in case of vitiligo. In order to achieve the best quality of this formulation physicochemical analysis i.e. fluorescence test, ash values, extractive values and moisture content of combined powdered drug of herbs and minerals were performed followed by phytopharmaceutical calculation of flow ability of blended powder by means of angle of repose, porosity, bulk and tap density, compressibility and hausner ratio, these properties assisted to estimate the best form of powdered material filled in right size of capsule for the desired strength i.e.500mg. Accelerated stability studies were also performed to establish the efficacy of the formulation. In this regard organoleptic properties (color, odor, appearance and taste), weight variation, disintegration and bio burden of ALG-06 formulation were monitored at 40°C/75% relative humidity (RH) along with a room temperature (RT) for a period of one month.