HPLC Method Development and Validation of Atorvastatin Calcium in Bulk and Tablet Dossage Form
Journal Title: RADS Journal of Pharmacy and Pharmaceutical Sciences - Year 2018, Vol 6, Issue 1
Abstract
Objective: The present work was aimed at the development of a simple, precise, rapid and selective RP-HPLC method for the estimation of Atorvastatin as API in both- bulk and pharmaceutical formulation. Methods:The method was carried out on HPLC a C18 column (25 cm x 4.6 mm) with mobile phase consisting of methanol:water:acetonitrile: orthophosphoric acid (85:10:4, 1 v/v) and pH was adjusted to 3.2 with flow rate of 1.8 ml per min.Detection was carried out at 247 nm. Besides, all parameters were found to be under required limits including limits of detection and limits of quantification.Further,the method was developed and validated; linearity, accuracy, precision, ruggedness and robustness, through an efficient HPLC technique in accordance with the ICH validation guidelines. Results:The results of all validated parameters - Linearity(r²= 0.999), Accuracy (101.5%) ,Precision, Ruggedness, Robustness, LOD (0.0008µg/ml) and LOQ (0.0002µg/ml) were found to be within required limits. Conclusion:As per above discussion the developed method is in accordance with ICH guidelines and can be easily used for Bulk and pharmaceutical formulation testing.
Authors and Affiliations
Saima Saleem
Keywords
Related Articles
- EP ID EP604394
- DOI -
- Views 179
- Downloads 0
Formulation and In-Vitro Evaluation of Polymers Blend Based Diclofenac Sodium Microparticles for Sustained Release Drug Delivery
Purpose: The purpose of research was to formulate polymeric blend based Diclofenac sodium microparticles for sustained release drug delivery. Method: The diclofenac sodium microparticles were formulated by emulsificatio...
Prevalence of Hirsutism in The Islamia University Bahawalpur, Pakistan
Objective: Population based studies on hirsutism, variability with age and distribution, their associated symptoms are limited in Pakistan. Knowledge on the awareness about hirsutism, variability and their associated sym...
Single Blind, Placebo Control Phase III Study of Insty Granules to Evaluate its Efficacy and Safety
Aims and objectives: Cold symptoms are well recognized as sore throat, nasal congestion and clogging, sneezing, coughing, headache and fatigue. This clinical trial was conducted to evaluate the efficacy and safety of Ins...
Method Development and Validation of RP-HPLC Method For Estimation of Eplerenone In Bulk and Pharmaceutical Formulations
Objective:This method focused on development of simple, selective and precise liquid chromatographic method for determination of Eplerenone in API (Active Pharmaceutical Ingredient) and pharmaceutical formulations Metho...
Adipose tissue-resident macrophages and obesity
Type 2 diabetes and insulin resistance are one of the major consequences of obesity as a result of inflammation in adipose tissues. Adipose tissue-resident macrophages (ATMs) have a primary role in tissue remodeling and...