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Ph.D.
(Pharmacy)
DEVELOPMENT AND VALIDATION OF ANALYTICAL METHODS FOR
THE ESTIMATION OF DRUGS USED FOR THE TREATMENT OF
RESPIRATORY DISEASES
Ph.D. Scholar : Patel Bhoomiben Hasmukhbhai
Research Supervisor : Dr. Satish A Patel

Regi. No.: 16146021010
Abstract :
The present work represents UV spectrophotometric method, Chemometrics assisted UV
spectrophotometric method, RP-HPLC, and Stability indicating RP-HPLC method for the
determination of anti-viral drugs in single and in the combined dosage form. The
Difference spectroscopic method was developed for the estimation of Daclatasvir
Dihydrochloride in dosage form. The simultaneous estimation of Sofosbuvir and
Daclatasvir Dihydrochloride in the dosage form was accomplished by the application of
the Dual wavelength method, Ratio derivative method, Chemometrics (CLS, ILS, PCR and
PLS) assisted UV spectroscopic methods. UV spectrophotometric methods like the
Simultaneous equation method, Q - absorbance ratio method, Dual Wavelength method,
First Derivative Method, Ratio Derivative Method were developed for the simultaneous
determination of Lamivudine and Dolutegravir Sodium in dosage form. The RP-HPLC
method was developed for the simultaneous determination of Lamivudine and
Dolutegravir Sodium in the dosage form. Chemometrics assisted (CLS, ILS, PCR and PLS)
spectrophotometric methods and Ratio Derivative (Double Divisor) Method have been
developed for simultaneous estimation of Abacavir Sulphate, Lamivudine and
Dolutegravir Sodium in the dosage form. The Stability Indicating RP-HPLC method and
Chemometrics-assisted UV spectrophotometric method were developed for the
simultaneous estimation of Emtricitabine, Tenofovir Alafenamide Fumarate and
Dolutegravir Sodium in the dosage form. The degradation study was carried out under
different environments like acidic, alkaline, neutral, oxidative, photolytic and thermal
conditions. All the developed methods were validated in terms of linearity, accuracy,
precision, robustness, limit of detection, the limit of quantitation, repeatability and system
suitability as per ICH Q2 (R1) guideline. The developed methods were statistically
compared using one way ANOVA.
The calibration curve of all the developed methods was found linear over the proposed
concentration range. Percentage assay values and Percent recoveries of the drug were
obtained within the limit specified in ICH guidelines i.e. 98-102%. The stability indicating
RP-HPLC method was able to detect and/or separate the drugs from their degradants.
Statistical outcomes suggested that there exists no significant difference between the
developed methods. All the developed methods were found simple, sensitive, accurate,
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