Development and Validation of Analytical Methods for Estimation of Calcium Channel Blocker PDF

**A SYNOPSIS** **ON** **Development and validation of analytical methods for estimation of calcium channel blocker** In the partial fulfilment of the requirement For the award of the Degree of **Master of Pharmacy (Quality Assurance)** **Submitted by** **ROHIT KUMAR DWIVEDI** Roll no. 220370...

**A SYNOPSIS** **ON** **Development and validation of analytical methods for estimation of calcium channel blocker** In the partial fulfilment of the requirement For the award of the Degree of **Master of Pharmacy (Quality Assurance)** **Submitted by** **ROHIT KUMAR DWIVEDI** Roll no. 220370805014 **Under the guidance of** **Mrs. Sunita Arya** **Under the co-guidance of** **Dr. Divyanshi Rastogi** download **Gyani Inder Singh Institute of Professional Studies,** **Dehradun, Uttarakhand**  **Veer Madho Singh Bhandari Uttarakhand Technical University (VMSBUTU), Dehradun, Uttarakhand** **2023-2024** **\ ** download**Gyani Inder Singh Institute of Professional Studies,Dehradun, Uttarakhand** **[FORWARDING CERTIFICATE]** **This to certify that the work incorporated in the synopsis entitled "Development and validation of analytical methods for estimation of calcium channel blocker" submitted by ROHIT KUMAR DWIVEDI bearing roll no. 220370805014, in the partial fulfillment of the requirement for the award of degree of Master of Pharmacy Quality Assurance of Veer Madho Singh Bhandari Uttarakhand Technical University, Dehradun, Uttarakhand, India is a bonafide research work by him in Gyani Inder Singh Institute of Professional Studies, Uttarakhand, India.** **SIGNATURE OF EXTERNAL EXAMINER SIGNATURE OF DIRECTOR** **\ ** **Gyani Inder Singh Institute of Professional Studies, Dehradun, Uttarakhand** **[CERTIFICATE]** **This is to certify that ROHIT KUMAR DWIVEDI carried out the research work presented in this synopsis entitled "Development and validation of analytical methods for estimation of calcium channel blocker" for the award of degree of Master in Quality assurance from Veer Madho Singh Bhandari Uttarakhand Technical University, Dehradun under my supervision. The synopsis embodies original work & study are carried out by student himself & the content of synopsis do not from the award of any other degree to the candidate or to anybody else from this or any other University/Institution.** **SIGNATURE OF SUPERVISOR** **SUPERVISOR NAME** **Mrs. Sunita arta** **SIGNATURE OF CO-SUPERVISOR** **CO-SUPERVISOR NAME** **Dr. Divyanshi rastogi** **\ ** download**Gyani Inder Singh Institute of Professional Studies,Dehradun, Uttarakhand** **[DECLARATION BY THE CANDIDATE]** I hereby that the synopsis entitled "**Development and validation of analytical methods for estimation of calcium channel blocker"** is a bonafide and genuine research work will be pursued by me under the guidance of **Mrs. Sunita Arya and Dr. Divyanshi Rastogi, Gyani Inder Singh Institute of Professional studies,** Dehradun, Uttarakhand. **SIGNATURE OF STUDENT** **Rohit kumar dwivedi** **M.PHARM (QUALITY ASSURANCE)** **\ ** **TABLE OF CONTENTS** -------------------------- -------------- **PAGE NO.** **DRUG PROFILE** **LITERATURE SURVEY** **AIMS AND OBJECTIVES** **DRUG PROFILE** **RESEARCH METHODOLOGY** -------------------------- -------------- ***\ *** 1. **INTRODUCTION** **\ ** - - -- -- -- -- -- -- **Diastolic (bottom** **number)** 160 or higher *And* *Or* *Or* *Or* *\ * Less than 80 80--89 90--99 100 or higher - -  1. 2. - - - - - - 3. HPTLC can be used to study purity profile of medicinal substance and to compendial content uniformity test. It is also useful for dissolution studies, BA/BE studies and stability studies. Federal authorities are now recognizing the analytical data collected during the BA / BE studies of the newer molecule. The HPTLC method not only fulfills the basic criteria for quantitative and qualitative research but it is also capable of beingused by personnel with limited technical expertise and under reasonable laboratory facilities. - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - For the establishment of linearity, minimum 5 concentrations are recommended. - - - - - - - - - - - - - - - - - - However, the guideline provides no details on how hydrolytic, photolytic and oxidative studies have to be actually performed. **\ ** 2. **DRUG PROFILE** **\ ** : 4-\[5-(4-methylphenyl)-3(trifluoromethyl) pyrazol :[C17H14F3N3O2S](https://pubchem.ncbi.nlm.nih.gov/#query=C17H14F3N3O2S) : 381.4 g/mol  : 22-40% : 97% : 11 hours : Oral : Ethanol, DMSO, Dimethyl Formamide 5. - - - - - - - 3. **LITERATURE SURVEY** **\ ** 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. **\ ** 4. **AIMS AND OBJECTIVES** **\ ** 1. Development and validation of stability indicating HPTLC methods for the estimation of antihypertensive drugs (Lisinopril Dihydrate, Felodipine, and Cilnidipine) in their pharmaceutical dosage forms. 2. To study the degradation kinetics of Lisinopril Dihydrate in oxidative medium and Felodipine in alkaline medium 3. To develop and validate HPTLC method for simultaneous estimation of Lercanidipine Hydrochloride and Enalapril Maleate in their laboratory mixture 4. Development and validation of HPTLC method for estimating Azilsartan Medoxomil in its pharmaceutical dosage forms 5. (methanol and acetonitrile; 50:50, v/v). The eluted compounds were monitored at255 nm. CEL and DIN were subjected to oxidative, acid, base, hydrolytic, thermal and photolytic stress conditions. 6. The limit of quantitation results were ranged from 0.07 to 0.09 mg/mL for CEL impurities and 0.052 to 0.065 mg/mL for DIN impurities. This method is suitable for the estimation of impurities and assay of CEL and DIN in capsule dosage forms. 5. **RESEARCH METHODOLOGY** **\ ** **METHODOLOGY** : 10mg b. - - - - - - - - - - - - **6. REFERENCES** **\ ** 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34.