Surajpal Verma

RP-HPLC Method Development and Validation for Simultaneous Estimation of Clarithromycin and Paracetamol

The present work describes a simple, rapid, and reproducible reverse phase high performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of clarithromycin (CLA) and paracetamol (PCM). C18 column (Kromasil ODS, 5u2009µm, 250 × 4.6u2009mm) and a mobile phase containing phosphate buffer (0.05u2009M) along with 1-octane sulphonic acid sodium salt monohydrate (0.005u2009M) adjusted to pH 3.2: acetonitrile (50u2009:u200950u2009v/v) mixture was used for the separation and quantification. The flow rate was 1.0u2009mL/min and the eluents were detected by UV detector at 205u2009nm. The retention times were found to be 2.21 and 3.73u2009mins, respectively. The developed method was validated according to ICH guidelines Q2 (R1) and found to be linear within the range of 75–175u2009µg/mL for both drugs. The developed method was applied successfully for assay of clarithromycin and paracetamol in their combined in-house developed dosage forms and in vitro dissolution studies.

Sublingual Delivery of Frovatriptan: An Indication of Potential Alternative Route

Frovatriptan, a 5-HT1B and 5-HT1D receptor agonist, is used for the treatment of acute migraine attack. This molecule is classified into second line therapy because of its slow onset of action (peak response obtained after 4 hours of administration) and low bioavailability (25%). Moreover, its therapy is the most costly among all triptans. Attempt has been made in present work to suggest a way out to fasten its onset of action and to enhance its bioavailability. Prepared tablets were evaluated by physicochemical tests, in vitro permeation studies, ex vivo permeation studies, and histopathological studies. Suitable mathematical calculations were performed to calculate the minimum amount of bioavailability that could be enhanced. Tablets containing chitosan (5% w/w) were found to give optimum results. Prepared tablets can double the bioavailability of frovatriptan and can initiate its response within 10 minutes of its administration. Suggestive alternative has the potential to increase the efficacy of frovatriptan for treating acute migraine attack.

A Stability Indicating Assay Method Development and Validation for the Frovatriptan Succinate Monohydrate by Using UV: A Spectrophotometric Technique

A new simple, reliable, inexpensive, and accurate method was developed for the quantification of Frovatriptan Succinate Monohydrate in different physiological media at 244u2009nm in bulk and in tablet dosage forms. The developed method is an attempt to surpass the disadvantages associated with the reported methods, namely, less sensitive and tedious in usage for routine purposes. Beer’s law was followed over the range of 1.0u2009µg/mL to 4.5u2009µg/mL. Stability indicating assay method was developed and validated as per the ICH guidelines using various parameters, for example, accuracy, precision, limit of quantification, limit of detection, robustness, ruggedness, solution stability, recovery, forced degradation (hydrolysis, photo degradation, thermal degradation, and oxidation), and so forth. Percent relative standard deviation associated with all the parameters was less than 2, showing compliance with the acceptance criteria of ICH guidelines. The developed method was very sensitive as limit of quantification and limit of detection were found to be 0.025u2009µg/mL and 0.00625u2009µg/mL, respectively. Forced degradation studies of drug reveal good stability under the chosen experimental conditions.