DEVELOPMENT AND VALIDATION OF A STABILITY INDICATING RP-HPLC METHOD FOR THE DETERMINATION OF POTENTIAL DEGRADATION PRODUCTS OF DIFLUPREDNATE IN OPHTHALMIC EMULSION
Journal Title: International Journal of Pharmacy and Pharmaceutical Sciences - Year 2018, Vol 10, Issue 9
Abstract
Objective: The objective of the current study was to develop and validate a simple, robust, precise and accurate RP-HPLC (reverse phase-high performance liquid chromatography) method for the quantitative determination of potential degradation products of Difluprednate (DIFL) in the ophthalmic emulsion.Methods: Chromatographic separation was achieved on the YMC pack ODS-AQ (150× 4.6) mm, 3μm column with a mobile phase containing a gradient mixture of mobile phase A (0.02M Ammonium formate buffer pH 4.5 adjusted with formic acid) and Acetonitrile as mobile phase B, at flow rate of 1.5 ml/min and with UV detection at 240 nm.Results: The peak retention time of DIFL was found at about 17.2 min, the RRT of degradation product-1 (DP-1), degradation product-2 (DP-2), and degradation product-3 (DP-3), were found to be about 0.49, 0.65 and 0.79 respectively (calculated with respect to Difluprednate). Stress testing was performed in accordance with an ICH (international council for harmonisation) guideline Q1A (R2) [1]. The method was validated as per ICH guideline Q2 (R1)[2]. The calibration curve was found to be linear in the concentration range of 0.1 to 0.75 µg/ml for Difluprednate, DP-1, DP-2 and DP-3. The LOD (Limit of detection) was found to be 0.1µg/ml and LOQ (Limit of quantification) of 0.15µg/ml for Difluprednate, DP-1, DP-2 and DP-3 respectively. The recovery from LOQ to 150% was within 90-110%. The forced degradation data confirms the stability indicating the nature of the method.Conclusion: A simple, robust, precise and accurate RP-HPLC method for the quantitative determination of potential degradation products of Difluprednate in the ophthalmic emulsion was developed and validated.Â
Authors and Affiliations
Murlidhar V. Zope, Rahul M. Patel, Ashwinikumari Patel, Samir G. Patel
Keywords
Related Articles
- EP ID EP566162
- DOI 10.22159/ijpps.2018v10i9.26342
- Views 79
- Downloads 0
EVALUATION OF HEPATOPROTECTIVE ACTIVITY OF STEM EXTRACTS OF CUSCUTA REFLEXA (ROXB) IN RATS
Objective: Cuscuta Reflexa (Convolvulaceae) is a plant with a variety of ethnic medicinal uses along with antioxidant activity. Hence it was planned to evaluate the hepatoprotective activity with alcoholic extracts of st...
EFFECT OF AQUEOUS EXTRACT OF AZOLLA FILICULOIDES IN GASTRIC MUCOSA OF ULCERATED RATS
Objective: To investigate the anti ulcer effect of aqueous extract of Azolla  filiculoides (AF) in experimentally induced gastric ulceration in male Wistar rats.Methods: Twenty four rats were divided into four groups of...
ANTIMICROBIAL PEPTIDE P34 INFLUENCES GENE EXPRESSION OF LISTERIA MONOCYTOGENES GROWING IN SOFT CHEESE
Objective: To evaluate whether antimicrobial substances produced by autochthonous lactic acid bacteria (LAB) from Minas Frescal cheese are able to enhance the activity of bacteriocin P34 against Listeria monocytogenes an...
PHARMACOVIGILANCE/REPORTING ADVERSE DRUG REACTIONS: AN APPROACH TO ENHANCE HEALTH SURVEILLANCE AND EXTENDING MARKET SHARE BY MINIMIZING THE CHANCES OF DRUG WITHDRAWALS
Any unintended response of a drug which; apart from the doses that cover therapy of a disease; includes lack of efficacy, overdose and its misuse can be termed as an adverse drug reaction. In this scenario, adverse effec...
PHYTOCHEMICAL COMPOSITION OF SARGASSUM POLYCYSTUM C. AGARDH AND SARGASSUM DUPLICATUM J. AGARDH
Objective: The present study was aimed to reveal the phytochemical composition of Sargassum polycystum C. Agardh and Sargassum duplicatum J. Agardh from Manapad, Thoothukudi district, Tamil Nadu, India.Methods: Seaweeds...